- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04309656
A Study in Two Panels of Healthy Adult Participants to Assess Single-Dose Immediate-Release and Single-Dose Dispersible Formulations of Pretomanid
March 13, 2020 updated by: Global Alliance for TB Drug Development
An Open-label, Randomized, Four-period, Crossover Study in Two Panels of Healthy Adult Subjects to Assess the Relative Bioavailability, Food Effect, and Dose-dependence of Single-dose Immediate-release and Single-dose Dispersible Formulations of Pretomanid
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
Each panel of 24 subjects will be randomized according to the same 4-sequence, 4- period Williams design, in which each participant will receive four single-dose treatments.
Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours.
Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours.
The two panels will be investigated concurrently.
Study Type
Interventional
Enrollment (Actual)
48
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
-
-
Texas
-
San Antonio, Texas, United States, 78217
- Worldwide Clinical Trials Early Phase Services, LLC
-
-
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
19 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
- Male or female. Females must not be pregnant or breastfeeding.
- Willing and able to comply with the contraception requirements.
- Between 19 and 50 years of age (inclusive) at the time of screening.
- Body mass index (BMI) between 18.50 and 32 kg/m2 (inclusive) and weighs a minimum of 50 kg.
- Willing and able to remain in the study unit for the entire confinement period and return for the outpatient follow-up visit.
- Willing and able to consume the entire high-calorie, high-fat breakfast meal in the timeframe required during the designated study period.
- Willing and able to comply with the protocol and the assessments therein, including all restrictions.
Exclusion Criteria:
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
- A clinically significant abnormal finding on the physical examination, medical history, electrocardiogram (ECG), or clinical laboratory results.
- Vital signs at screening (measured sitting after a minimum 3 minutes rest) as follows: blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg or a heart rate lower than 40 bpm or higher than 99 bpm. Out-of-range vital signs may be repeated once.
- History or presence of allergic or adverse response to pretomanid or related drugs.
- On a significantly abnormal diet during the 4 weeks preceding the first dose of study medication.
- Participation in another clinical trial (randomized subjects only) within 30 days before the first dose of study medication.
- Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, or vitamins) within 7 days before the first dose of study medication until the end of study visit without evaluation and approval by the Investigator. Up to 3 grams per day of acetaminophen is allowed at the discretion of the Investigator prior to dosing.
- Use of any prescription medication, except hormonal contraceptive or hormonal replacement therapy, from 14 days before the first dose of study medication until the end-of-study visit without evaluation and approval by the Investigator.
- Use of any drugs or substances known to lower the seizure threshold.
- Use of any drugs or treatment with any known drugs that are moderate or strong inducers or inhibitors of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) and/or P-gp, including St. John's Wort, within 30 days before the first dose of study medication, and that, in the Investigator's judgment, may impact subject safety or the validity of the study results.
- Female with a positive pregnancy test result.
- Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine.
- Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) at screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
- Hemoglobin <10.0 g/dL.
- ALT (alanine transaminase) or AST (aspartate aminotransferase) >2.0 x the upper limit of normal (ULN).
- Hyperbilirubinemia >1.5 x ULN.
- Surgery within the past 90 days prior to dosing as determined by the Investigator to be clinically relevant.
- History or presence of alcoholism or drug abuse within the past 2 years as determined by the Investigator to be clinically relevant.
- Any clinically significant electrocardiogram abnormality at Screening (as deemed by decision of the Investigator and the Study Sponsor's Medical Monitor).
- QTcF interval >450 msec for males or >470 msec for females at screening, Day -1, or Day 1 (pre-dose), or history of prolonged QT syndrome.
- Family history of Long-QT Syndrome or sudden death without a preceding diagnosis of a condition that could be causative of sudden death (such as known coronary artery disease, congestive heart failure or terminal cancer).
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Panel 1: Pretomanid after meal
Each participant will receive four single-dose treatments.
Panel 1 will receive a meal before dosing.
|
Other Names:
|
EXPERIMENTAL: Panel 2: Pretomanid after fast
Each participant will receive four single-dose treatments.
Panel 2 will fast before dosing.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative bioavailability - Cmax
Time Frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Bioavailability will be determined separately for each panel using Cmax (maximum plasma concentration)
|
intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Relative bioavailability - AUC 0-t
Time Frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Bioavailability will be determined separately for each panel using AUC 0-t (area under the time vs concentration curve from time 0 to time t)
|
intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Relative bioavailability - AUC 0-inf
Time Frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Bioavailability will be determined separately for each panel using AUC 0-inf (area under the time vs concentration curve from time 0 to infinite time)
|
intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food effect - Cmax
Time Frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Food effect on bioavailability will be determined separately for each panel using Cmax.
|
intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Food effect - AUC 0-t
Time Frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Food effect on bioavailability will be determined separately for each panel using AUC 0-t.
|
intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Food effect - AUC 0-inf
Time Frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Food effect on bioavailability will be determined separately for each panel using AUC 0-inf.
|
intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Dose effect - Cmax
Time Frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Dose effect on bioavailability of the dispersible pediatric formulations will be determined separately for each panel using Cmax.
|
intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Dose effect - AUC 0-t
Time Frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Dose effect on bioavailability of the dispersible pediatric formulations will be determined separately for each panel using AUC 0-t.
|
intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Dose effect - AUC 0-inf
Time Frame: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Dose effect on bioavailability of the dispersible pediatric formulations will be determined separately for each panel using AUC 0-inf.
|
intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
|
Taste perception of pediatric formulations by questionnaire
Time Frame: On days 1, 8, 15, and 22 following dosing
|
Formulations will be evaluated for taste, smell and mouth feel.
Each item is scored on a scale of 1 to 5 with higher values indicating a more negative result.
|
On days 1, 8, 15, and 22 following dosing
|
Adverse Events - relatedness using Adverse Event Attribution/Causality Ratings
Time Frame: throughout the study, approximately 33 days
|
Study participants will be monitored daily for adverse events.
Reported adverse events (AE) will be rated for relatedness on five levels, from not related to certain.
Moving higher on the scale means increased likelihood of the event being related to treatment.
|
throughout the study, approximately 33 days
|
Adverse events - severity
Time Frame: throughout the study, approximately 33 days
|
Study participants will be monitored daily for AE.
Reported events will be rated for severity using Division of Microbiology and Infectious Disease (DMID) Toxicity Tables.
|
throughout the study, approximately 33 days
|
Adverse events - overall incidence
Time Frame: throughout the study, approximately 33 days
|
The overall number of AE will be collected.
|
throughout the study, approximately 33 days
|
Adverse events - AE leading to withdrawal
Time Frame: throughout the study, approximately 33 days
|
The number of AE leading to withdrawal from the study will be collected.
|
throughout the study, approximately 33 days
|
Adverse events - Serious Adverse Events
Time Frame: throughout the study, approximately 33 days
|
The number of serious adverse events (SAEs) will be collected.
|
throughout the study, approximately 33 days
|
Vital signs - blood pressure
Time Frame: days 1-26 and day 33
|
Systolic and diastolic blood pressure will be measured daily.
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days 1-26 and day 33
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Vital signs - pulse rate
Time Frame: days 1-26 and day 33
|
Pulse rate will be taken daily.
|
days 1-26 and day 33
|
Vital signs - body temperature
Time Frame: days 1-26 and day 33
|
Temperature will be taken daily.
|
days 1-26 and day 33
|
Vital signs - respiration rate
Time Frame: days 1-26 and day 33
|
Respiration rate will be measured daily.
|
days 1-26 and day 33
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Vital signs - pulse oximetry
Time Frame: days 1-26 and day 33
|
Pulse oximetry measurements will be made daily.
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days 1-26 and day 33
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Vital signs - body weight
Time Frame: days 1-26 and day 33
|
Body weight will be measured daily.
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days 1-26 and day 33
|
Electrocardiogram (ECG) - Heart rate
Time Frame: intake (predose), day 1, day 8, day 15, day 22, and day 33
|
Heart rate will be evaluated from an ECG.
|
intake (predose), day 1, day 8, day 15, day 22, and day 33
|
Electrocardiogram (ECG) - PR interval
Time Frame: intake (predose), day 1, day 8, day 15, day 22, and day 33
|
PR interval will be evaluated from an ECG.
|
intake (predose), day 1, day 8, day 15, day 22, and day 33
|
Electrocardiogram (ECG) - RR interval
Time Frame: intake (predose), day 1, day 8, day 15, day 22, and day 33
|
RR interval will be evaluated from an ECG.
|
intake (predose), day 1, day 8, day 15, day 22, and day 33
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Electrocardiogram (ECG) - QRS complex
Time Frame: intake (predose), day 1, day 8, day 15, day 22, and day 33
|
QRS complex will be evaluated from an ECG.
|
intake (predose), day 1, day 8, day 15, day 22, and day 33
|
Electrocardiogram (ECG) - QT interval
Time Frame: intake (predose), day 1, day 8, day 15, day 22, and day 33
|
QT interval will be evaluated from an ECG.
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intake (predose), day 1, day 8, day 15, day 22, and day 33
|
Electrocardiogram (ECG) - QTc interval (corrected by Bazett's formula)
Time Frame: intake (predose), day 1, day 8, day 15, day 22, and day 33
|
QTc interval (corrected by Bazett's formula) will be evaluated from an ECG.
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intake (predose), day 1, day 8, day 15, day 22, and day 33
|
Electrocardiogram (ECG) - QTc interval (corrected by Fridericia's formula)
Time Frame: intake (predose), day 1, day 8, day 15, day 22, and day 33
|
QTc interval (corrected by Fridericia's formula) will be evaluated from an ECG.
|
intake (predose), day 1, day 8, day 15, day 22, and day 33
|
Hematology - hemoglobin
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Hemoglobin will be measured in blood sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Hematocrit- hematocrit
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Hematocrit will be measured in blood sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Hematology- Total and differential leukocyte count
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Total and differential leukocyte count will be measured in blood sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Hematology- Red blood cell count
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Red blood cell count will be measured in blood sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Hematology- Platelet count
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Platelet count will be measured in blood sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - albumin
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Albumin will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - blood urea nitrogen
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Blood urea nitrogen will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - creatinine
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Creatinine will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - total bilirubin
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Total bilirubin will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - alkaline phosphatase
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Alkaline phosphatase will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - aspartate transaminase
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Aspartate transaminase will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - alanine transaminase
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Alanine transaminase will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - sodium
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Sodium will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - potassium
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Potassium will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - chloride
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Chloride will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - lactate dehydrogenase
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Lactate dehydrogenase will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - calcium
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Calcium will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - uric acid
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Uric acid will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - glucose
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Glucose will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - gamma-glutamyl transferase
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Gamma-glutamyl transferase will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Serum chemistry - magnesium
Time Frame: intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Magnesium will be measured in serum sample.
|
intake (predose), day 5, day 12, day 19, day 26, and day 33
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cynthia A Zamora, Worldwide Clinical Trials Early Phase Services, LLC
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.
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)
January 14, 2020
Primary Completion (ACTUAL)
February 28, 2020
Study Completion (ACTUAL)
February 28, 2020
Study Registration Dates
First Submitted
January 23, 2020
First Submitted That Met QC Criteria
March 13, 2020
First Posted (ACTUAL)
March 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 16, 2020
Last Update Submitted That Met QC Criteria
March 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pa-824-CL-011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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