To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.

September 14, 2020 updated by: GlaxoSmithKline

A Phase I; Multi-Center; Open-Label (Parts 1 and 2); Randomized, Double-Blind, Placebo-Controlled (Part 3); Single-Dose; 3-Part Study to Evaluate the Relative Bioavailability of Three Formulations in Healthy Subjects, Food Effect on Tablet Formulation in Healthy Subjects, and Pharmacokinetics of Gepotidacin (GSK2140944) in Japanese Subjects in Fasted and Fed States

This study is divided in 2 parts. Part 1a is being conducted to evaluate the safety, tolerability, and relative bioavailability of the 2 free base tablet formulations (roller compacted [RC] and high shear wet granulation [HSWG]) compared to the reference capsule formulation under fasted conditions. This is a 3-period; cross-over study that will guide which gepotidacin formulation will be used for future studies. Following review of pharmacokinetic (PK) and safety data in Part 1a, a decision will be made whether to proceed with Parts 1b and 2.

Part 1b is a 2-period, cross-over study and will assess the effect of food on the PK of the selected gepotidacin tablet formulation from Part 1a. In Part 2, the PK of the selected gepotidacin tablet formulation from Part 1a in Japanese (2a) and Chinese (2b) subjects will be evaluated under fasted conditions.

The duration of the study (from Screening to the Follow-up visit) will be approximately 44 days (Part 1a), 41 days (Part 1b) and 38 days (Part 2a and 2b each), respectively. The approximate number of subjects enrolled in Part 1a will be 27 (9 subjects in each of the 3 treatment sequences), 16 in Part 1b (8 subjects in each of the 2 treatment sequences) and 12 Japanese and 12 Chinese subjects in Part 2a and 2b, respectively.

Study Overview

Status

Completed

Conditions

Infections, Bacterial

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Anaheim, California, United States, 92801
    - GSK Investigational Site
- Texas
  - Austin, Texas, United States, 78744
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

Male or female subjects between 18 and 64 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the investigator based on medical history, clinical laboratory results (serum chemistry, hematology, urinalysis, and serology), vital sign measurements, 12-lead ECG results, and physical examination findings. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator feels and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Additional inclusion criteria for Japanese subjects (Part 2a only): the subject was a non-naturalized Japanese citizen and held a Japanese passport, the subject had 2 Japanese parents and 4 Japanese grandparents who were all non naturalized Japanese citizens, as confirmed by interview and the subject had been living outside of Japan for up to 10 years as confirmed by interview.
Additional inclusion criteria for Chinese subjects (Part 2b only): the subject was a non-naturalized Chinese citizen and held a Chinese passport, the subject had 2 Chinese parents and 4 Chinese grandparents who were all non naturalized Chinese citizens, as confirmed by interview, the subject had been living outside of China for up to 10 years as confirmed by interview.
Body weight for subjects in Part 1a and 1b: more than equal to (>=) 50 kilogram (kg) and body mass index (BMI) within the range 19 and 32 kilogram per meter square (kg/m^2), inclusive and for Japanese and Chinese subjects (Part 2a and 2b): >=50 kg and BMI within the range 18 and 32 kg/m^2, inclusive.
Male or female: a female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin test, not lactating, and at least one of the following conditions applies. Non-reproductive potential defined as: pre-menopausal females with one of the following: documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, documented bilateral oophorectomy and postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle-stimulating hormone and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential from 30 days prior to the first dose of study medication and until completion of the Follow-up visit.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Exclusion Criteria

Subject has a clinically significant abnormality in past medical history or at the Screening physical examination that in the investigator's opinion may place the subject at risk or interfere with outcome variables of the study. This includes, but is not limited to, history or current cardiac, hepatic, renal, neurologic, gastrointestinal, respiratory, hematologic, or immunologic disease.
Subject has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the subject at risk, in the opinion of the investigator.
QTc more than (>) 450 millisecond (msec).
Use of a systemic antibiotic within 30 days of Screening.
Within 2 months before Screening, either a confirmed history of Clostridium difficile diarrhea infection or a past positive Clostridium difficile toxin test.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinic uses heparin to maintain intravenous cannula patency).
Subjects cannot use any over-the-counter, or prescription medication (except for hormonal contraceptives and/or acetaminophen), vitamin supplement, or herbal medication within 7 days (or 5 half-lives, whichever is longer) before dosing and during the study.
History of regular alcohol consumption within 6 months of screening defined as an average weekly intake of >21 units (or an average daily intake of >3 units) for males or an average weekly intake of >14 units (or an average daily intake >2 units) for females. One unit is equivalent to 270 milliliter (mL) of full strength beer, 470 mL of light beer, 30 mL of spirits, or 100 mL of wine.
Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 3 months before screening.
History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
Presence of hepatitis B surface antigen, positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
Female subject has a positive pregnancy test result or is lactating at Screening or upon admission to the clinic.
ALT >1.5×upper limit of normal (ULN)
Bilirubin >1.5×ULN (isolated bilirubin >1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin less than [<] 35 percent [%]).
Urinalysis positive for blood without other cause identified.
A positive pre-study drug/alcohol screen.
A positive test for human immunodeficiency virus antibody.
Subject has clinically significant abnormal findings in serum chemistry, hematology, or urinalysis results obtained at Screening or Day -1.
Donation of blood in excess of 500 mL within 12 weeks prior to dosing or participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Previous exposure to gepotidacin within 12 months prior to the first dosing day.
Exclusion criteria for screening and baseline 12-lead ECG (a single repeat is allowed for eligibility determination): male subjects with heart rate <40 and >100 beats per minute (bpm), female subjects with heart rate <50 and >100 bpm, PR interval <120 and >220 msec for male and female subjects, QRS duration <70 and >120 msec in both male and female subjects and corrected QT interval using Bazett's formula (QTcB) or corrected QT interval using Fridericia's formula (QTcF) >450 msec in both male and female subjects. Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization). Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block [second degree or higher], Wolf Parkinson White syndrome), sinus pauses >3 seconds, non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats) or any significant arrhythmia which, in the opinion of the principal investigator and GlaxoSmithKline medical monitor, will interfere with the safety of the individual subject.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Subject is unable to comply with all study procedures, in the opinion of the investigator.
The subject should not participate in the study, in the opinion of the investigator or sponsor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part1a: Gepotidacin 1500 mg-Sequence A-capsules, B-RC, C-HSWG Subjects will be receive treatment sequence (ABC) which is a single dose of gepotidacin 1500 mg (three tablets of 500 mg) reference capsule (Treatment A) in Period 1, 1500 mg (two tablets of 750 mg) RC tablet (Treatment B) in Period 2 or 1500 mg (two tablets of 750 mg) HSWG tablet (Treatment C) in Period 3, according to randomization. There will be a washout period of at least 3 days between doses.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin Capsule It is a pink gelatin size 00 capsule with no identifying markings containing slightly agglomerated pale yellow to grayish yellow to yellowish gray powder. This is an immediate release capsules containing gepotidacin 500 mg (mesylate salt) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing capsules.
EXPERIMENTAL: Part1a: Gepotidacin 1500 mg-Sequence C-HSWG, A-capsules, B-RC) Subjects will receive treatment sequence (CAB) to receive a single dose of gepotidacin 1500 mg (two tablets of 750 mg) HSWG tablet (Treatment C) in Period 1, 1500 mg (three tablets of 500 mg) reference capsule (Treatment A) in Period 2 or 1500 mg (two tablets of 750 mg) RC tablet (Treatment B) in Period 3 according to randomization. There will be a washout period of at least 3 days between doses.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin Capsule It is a pink gelatin size 00 capsule with no identifying markings containing slightly agglomerated pale yellow to grayish yellow to yellowish gray powder. This is an immediate release capsules containing gepotidacin 500 mg (mesylate salt) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing capsules.
EXPERIMENTAL: Part1a: Gepotidacin 1500 mg-Sequence B-RC, C-HSWG, A-capsules) Subjects will receive treatment sequence (BCA) to receive a single dose of gepotidacin 1500 mg (two tablets of 750 mg) RC tablet (Treatment B) in period 1, 1500 mg (two tablets of 750 mg) HSWG tablet (Treatment C) in Period 2, or 1500 mg (three tablets of 500 mg) (Treatment A) in Period 3 reference capsule according to randomization.. There will be a washout period of at least 3 days between doses.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin Capsule It is a pink gelatin size 00 capsule with no identifying markings containing slightly agglomerated pale yellow to grayish yellow to yellowish gray powder. This is an immediate release capsules containing gepotidacin 500 mg (mesylate salt) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing capsules.
EXPERIMENTAL: Part1b: Gepotidacin 1500 mg-Sequence DE-fasted followed by fed Subjects will receive treatment sequence (DE) according to randomization which is a single 1500 mg (two tablets of 750 mg) dose of gepotidacin tablet (RC or HSWG) selected from Part 1a under fasted condition (Treatment D) in Period 1 followed by fed conditions (Treatment E) in period 2. There will be a washout period of at least 3 days between doses.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.
EXPERIMENTAL: Part1b: Gepotidacin 1500 mg-Sequence ED-fed followed by fasted Subjects will be receive treatment sequence (ED) according to randomization which is single 1500 mg (two tablets of 750 mg) dose of gepotidacin tablet (RC or HSWG) selected from Part 1a under fed condition (Treatment E) in period 1 followed by fasted conditions (Treatment D) in Period 2. There will be a washout period of at least 3 days between doses.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.
EXPERIMENTAL: Part 2a: Gepotidacin 1500 mg (RC or HSWG)- Japanese subjects Japanese subjects will receive a single 1500 mg (two tablets of 750 mg) dose of gepotidacin tablet (RC or HSWG) selected from Part 1a.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.
EXPERIMENTAL: Part 2b: Gepotidacin 1500 mg (RC or HSWG)- Chinese subjects Chinese subjects will receive a single 1500 mg (two tablets of 750 mg) dose of gepotidacin tablet (RC or HSWG) selected from Part 1a.	Drug: Gepotidacin RC Tablet The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets. Drug: Gepotidacin HSWG Tablet The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.

What is the study measuring?

Primary Outcome Measures

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a Time Frame: Up to 14 days	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Participants with non-serious AEs and SAEs has been reported. Safety Population comprised of all participants who received at least 1 dose of study medication and had at least 1 post dose safety assessment.	Up to 14 days
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Hematology Parameter Blood Ery. for Part 1a Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a Time Frame: Baseline and up to 14 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a Time Frame: Baseline and up to 14 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a Time Frame: Baseline and up to 14 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) for Part 1a Time Frame: Baseline and up to 14 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1a. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).	Baseline and up to 14 days
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a Time Frame: Up to 14 days	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 1a. Only categories with significant values have been presented.	Up to 14 days
Number of Participants With AEs and SAEs for Part 1b Time Frame: Up to 11 days	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Up to 11 days
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1b Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 1b Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1b Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum albuim and serum protein for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin in Part 1b Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1b Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 1b Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 1b Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 1b Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Hematology Parameter Blood Ery. for Part 1b Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1b Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Vital Sign Parameters SBP and DBP for Part 1b Time Frame: Baseline and up to 11 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in Vital Sign Parameter Heart Rate for Part 1b Time Frame: Baseline and up to 11 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in ECG Parameter Heart Rate for Part 1b Time Frame: Baseline and up to 11 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 1b Time Frame: Baseline and up to 11 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1b. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Baseline and up to 11 days
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1b Time Frame: Up to 11 days	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Up to 11 days
Number of Participants With Non-serious AEs and SAEs for Part 2 Time Frame: Up to 11 days	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.	Up to 11 days
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Clinical Chemistry Parameter Serum Estradiol for Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of chemistry parameter namely serum estradiol for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the indicated time point were analyzed. NA indicates standard deviation was not calculated as a single participant was analyzed.	Baseline and up to 11 days
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Hematology Parameter Blood Ery. for Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2 Time Frame: Baseline and up to 11 days	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2 Time Frame: Baseline and up to 11 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in Vital Sign Parameter Heart Rate for Part 2 Time Frame: Baseline and up to 11 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in ECG Parameter Heart Rate for Part 2 Time Frame: Baseline and up to 11 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2 Time Frame: Baseline and up to 11 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 2. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.	Baseline and up to 11 days
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2 Time Frame: Baseline and up to 11 days	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 4+ 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 2. Only categories with significant values have been presented.	Baseline and up to 11 days
Number of Participants With Non-serious AEs and SAEs for Part 3 Time Frame: Up to 14 days	AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.	Up to 14 days
Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3 Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3 Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3 Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3 Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin and serum creatinine for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm	Baseline and up to 14 days
Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3 Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3 Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3 Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3 Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in Hematology Parameter Blood Ery. for Part 3 Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3 Time Frame: Baseline and up to 14 days	Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3 Time Frame: Baseline and up to 14 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in Vital Sign Parameter Heart Rate for Part 3 Time Frame: Baseline and up to 14 days	Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in ECG Parameter Heart Rate for Part 3 Time Frame: Baseline and up to 14 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3 Time Frame: Baseline and up to 14 days	A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 3. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.	Baseline and up to 14 days
Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3 Time Frame: Up to 14 days	Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 3. Only categories with significant values have been presented.	Up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Barth A, Hossain M, Brimhall DB, Perry CR, Tiffany CA, Xu S, Dumont EF. Pharmacokinetics of Oral Formulations of Gepotidacin (GSK2140944), a Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor, in Healthy Adult and Adolescent Participants. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0126321. doi: 10.1128/AAC.01263-21. Epub 2021 Oct 11.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 4, 2016

Primary Completion (ACTUAL)

October 17, 2017

Study Completion (ACTUAL)

October 17, 2017

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (ESTIMATE)

August 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

117351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug-drug Interaction Study of Gepotidacin

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GlaxoSmithKline
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Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function

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A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Single Dose and Repeat Dose of GSK3342830

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Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)

Infections, Bacterial

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GlaxoSmithKline
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Completed

Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function

Infections, Bacterial

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GlaxoSmithKline

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A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants

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Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects

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A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis) (SIS)

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Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function

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A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome

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Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain

Pain, Postoperative | Complex Regional Pain Syndromes | Spinal Cord Injuries | Nerve Injury | Post Herpetic Neuralgia | Post-Stroke Pain | Post Radiation Brain Injury | Post Radiation Plexopathy | Nerve Root Avulsion

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National Institute of Neurological Disorders and Stroke (NINDS); National Institutes...

Completed

Scalar Closed Loop Intraoperative Study

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Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of Plasma Gepotidacin for Part 1a Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for pharmacokinetic (PK) analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 milliliters (mL) of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. The PK Parameter Population consisted of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. Statistics has been presented on geometric least square (LS) means.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Area Under the Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC [0-t]) of Plasma Gepotidacin for Part 1a Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Statistics has been presented on geometric LS means.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Relative Bioavailability of Drug (Frel) of Plasma Gepotidacin for Part 1a Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. NA indicates data was not available as this was the reference capsule the Frel of each tablet type was being compared to.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Maximum Observed Concentration (Cmax) Determined Directly From the Concentration Time Data of Plasma Gepotidacin for Part 1a Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Statistics has been presented on geometric LS means.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Time to First Occurrence of Cmax (Tmax) of Plasma Gepotidacin for Part 1a Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Plasma Gepotidacin for Part 1a Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Terminal Phase Half-life (t1/2) of Plasma Gepotidacin for Part 1a Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Total Unchanged Drug (Total Amount of Drug Excreted in Urine [Ae Total]) for Part 1a Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours	PK urine samples were collected at 0 (predose), 0 to 2, 2 ot 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours
Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Plasma Gepotidacin for Part 1a Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours
Renal Clearance of Drug in Urine (CLr) for Part 1a Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours
Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants available at the specific time points were analyzed (represented by n = X in the category titles).	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours
Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 12 Hours (AUC [0-12]) for Part 1a Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.
Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 24 Hours (AUC [0-24]) After Dosing for Part 1a Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours
Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 48 Hours (AUC [0-48]) After Dosing for Part 1a Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants with data available at the indicated time point were analyzed.	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours
AUC (0-infinity) of Plasma Gepotidacin for Part 1b Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
AUC (0-t) of Plasma Gepotidacin for Part 1b Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Cmax of Plasma Gepotidacin for Part 1b Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Tmax of Plasma Gepotidacin for Part 1b Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Tlag of Plasma Gepotidacin for Part 1b Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
t1/2 of Plasma Gepotidacin for Part 1b Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
AUC (0-infinity) of Plasma Gepotidacin for Part 2 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
AUC (0-t) of Plasma Gepotidacin for Part 2 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Cmax of Plasma Gepotidacin for Part 2 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Tlag of Plasma Gepotidacin for Part 2 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Tmax of Plasma Gepotidacin for Part 2 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
t1/2 of Plasma Gepotidacin for Part 2 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Total Unchanged Drug (Ae Total) for Part 2 Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.
Ae (t1-t2) for Part 2 Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.
AUC (0-12) for Part 2 Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.
AUC (0-24) for Part 2 Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.	PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.
AUC (0-48) for Part 2 Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.
fe% for Part 2 Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.
CLr for Part 2 Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.	PK urine samples were collected at pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.
AUC (0-infinity) of Plasma Gepotidacin for Part 3 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
AUC (0-t) of Plasma Gepotidacin for Part 3 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Cmax of Plasma Gepotidacin for Part 3 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Tmax of Plasma Gepotidacin for Part 3 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Tlag of Plasma Gepotidacin for Part 3 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
t1/2 of Plasma Gepotidacin for Part 3 Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period	Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.	Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period
Total Unchanged Drug (Ae Total) for Part 3 Time Frame: Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours	PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher	Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours

To Assess Bioavailability, Food Effect and Pharmacokinetics of Gepotidacin Tablets: A Phase I, Single-Dose, 2 Part Study in Healthy Subjects.

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Clinical Trials on Infections, Bacterial

Clinical Trials on Gepotidacin RC Tablet

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