- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02691325
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects
A Single Centre, Three Part, Randomised, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA™ Dry Powder Inhaler to Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21225
- GSK Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between 20 and 75 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Normal spirometry at Screening (forced expiratory volume in 1 second and forced vital capacity >=80% of predicted - measurements to be taken in triplicate and the highest value must be >=80% of predicted).
- A subject with a clinical abnormality or laboratory parameter(s) outside the reference range for the population being studied may be included only if the investigator, in consultation with the medical monitor if needed, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >=50 kilograms (kg) and body mass index (BMI) within the range 18 to 35 kg/square meter (m^2) (inclusive).
Male subjects. Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until at least 10 days after the last dose of study medication.
- Vasectomy with documentation of azoospermia.
- Male condom plus partner use of one of the contraceptive options: Contraceptive subdermal implant, Intrauterine device or intrauterine system, Combined estrogen and progestogen oral contraceptive, Injectable progestogen, Contraceptive vaginal ring and Percutaneous contraceptive patches.
Female subjects. Female subjects are eligible to participate if they are not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and a serum or urine hCG test on admission), 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; Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). 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.
- Female of reproductive potential (FRP) must agrees to the use of male condom with spermicide in addition to one of the following methods from the list of highly effective contraceptive methods from 30 days prior to the first dose of study medication and until at least 10 days after the last dose of study medication: Contraceptive subdermal implant; Intrauterine device or intrauterine system; Combined estrogen and progestogen oral contraceptive; Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject.
The list does not apply to FRP with same sex partners or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis, when this is their preferred and usual lifestyle. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and protocol.
Exclusion Criteria:
- Asthma or a history of asthma (except in childhood, which has now remitted).
- Alanine Aminotransferase (ALT) and bilirubin >1.5 Upper Limit of Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if fractionated and direct bilirubin <35%)
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Corrected QT interval by Fridericia's formula (QTcF) > 450 milliseconds (msec).
- Unable to refrain from the use of prescription drugs (except contraceptives and HRT) or non-prescription drugs (except acetaminophen), including vitamins, herbal and dietary supplements from 7 days before the first dose of study medication until the follow-up visit, unless in the opinion of the Investigator and GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedure or compromise subject safety.
- The subject has received any type of vaccination within 4 weeks of their first dose of study medication, or is expected to be vaccinated within 4 weeks after their last dose of study medication.
- Current smoker or a history of smoking within 6 months of Screening, or a total pack year history of >5 pack years. (number of pack years = [number of cigarettes per day/20] x number of years smoked)
- History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 alcoholic drinks for males or >7 alcoholic drinks for females. One alcoholic drink is equivalent to 12 grams (g) of alcohol: 12 ounces (360 milliliters [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- Unable to refrain from the consumption of Seville oranges, grapefruit or grapefruit juice, pummelos, exotic citrus fruits, or grapefruit hybrids from 7 days before all doses of study medication and until collection of the final pharmacokinetic sample in each study period.
- History of sensitivity to any of the study medications, or components thereof (including lactose and Magnesium stearate) 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 (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. Subjects with a positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C Ribonucleic acid (RNA) polymerase chain reaction (PCR) test is obtained.
- A positive test for Human Immunodeficiency Virus(HIV) antibody (according to local policies).
- A positive drug/alcohol screen at screening or on admission (Day -1). - Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period.
- The subject has participated in a clinical trial and has received an investigational product (excluding participation in Part A of this study) 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).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A (Sequence 1) - Placebo, GSK2269557 200 mcg
Subjects will receive a single dose of GSK2269557 matching placebo (one inhalation) in treatment period 1, and single dose of GSK2269557 200 microgram (mcg) (2 inhalations of GSK2269557 100 mcg) in treatment period 2 via the ELLIPTA DPI.
The washout period between each dosing day will be at least 14 days.
Doses of GSK2269557 may be modified based on emerging data.
|
GSK2269557 ELLIPTA DPI contains GSK2269557 blended with lactose and magnesium stearate.
This will be supplied in two strength of 100 mcg per blister.
Placebo ELLIPTA DPI contains lactose.
|
Experimental: Part A (Sequence 2) - GSK2269557 100 mcg, Placebo
Subjects will receive a single dose of GSK2269557 100 mcg (one inhalation) in treatment period 1, and single dose of GSK2269557 matching placebo (two inhalations) in treatment period 2 via the ELLIPTA DPI.
The washout period between each dosing day will be at least 14 days.
Doses of GSK2269557 may be modified based on emerging data.
|
GSK2269557 ELLIPTA DPI contains GSK2269557 blended with lactose and magnesium stearate.
This will be supplied in two strength of 100 mcg per blister.
Placebo ELLIPTA DPI contains lactose.
|
Experimental: Part A (Sequence 3) - GSK2269557 100 mcg, GSK2269557 200 mcg
Subjects will receive a single dose of GSK2269557 100 mcg (one inhalation) in treatment period 1, and single dose of GSK2269557 200 mcg (2 inhalations of GSK2269557 100 mcg) in treatment period 2 via the ELLIPTA DPI.
The washout period between each dosing day will be at least 14 days.
Doses of GSK2269557 may be modified based on emerging data.
|
GSK2269557 ELLIPTA DPI contains GSK2269557 blended with lactose and magnesium stearate.
This will be supplied in two strength of 100 mcg per blister.
Placebo ELLIPTA DPI contains lactose.
|
Experimental: Part B- GSK2269557 200 mcg
Subjects will receive repeated doses of GSK2269557 200 mcg (2 inhalations of GSK2269557 100 mcg) once daily via the ELLIPTA DPI for 10 days.
Doses of GSK2269557 may be modified based on emerging data from Part A.
|
GSK2269557 ELLIPTA DPI contains GSK2269557 blended with lactose and magnesium stearate.
This will be supplied in two strength of 100 mcg per blister.
|
Experimental: Part B- GSK2269557 matching Placebo
Subjects will receive repeated doses of GSK2269557 matching Placebo (2 inhalations) once daily via the ELLIPTA DPI for 10 days.
|
Placebo ELLIPTA DPI contains lactose.
|
Experimental: Part C- GSK2269557 200 mcg with and without activated charcoal
Subjects will receive a single dose of GSK2269557 200 mcg (2 inhalations of GSK2269557 100 mcg) via the ELLIPTA DPI with activated charcoal in one treatment period and without ingestion of activated charcoal in another treatment period.
The washout period between each dosing day will be at least 14 days.
Dose of GSK2269557 may be modified based on emerging data from Part A.
|
GSK2269557 ELLIPTA DPI contains GSK2269557 blended with lactose and magnesium stearate.
This will be supplied in two strength of 100 mcg per blister.
The activated charcoal will be supplied by the clinical site.
Charcoal will be administered as a suspension of 5 gram activated charcoal in 40 mL of water.
The suspension will be made to drunk, in its entirety.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part A: Number of subjects with any adverse event(s) (AE) and serious adverse event(s) (SAE)
Time Frame: Up to 6 weeks
|
An AE is any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
|
Up to 6 weeks
|
Part B and C: Number of subjects with any AE and SAE
Time Frame: Up to 4 weeks
|
An AE is any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
|
Up to 4 weeks
|
Part A: Systolic and diastolic blood pressure as a measure of safety
Time Frame: Up to 9 weeks
|
Up to 9 weeks
|
|
Part B: Systolic and diastolic blood pressure as a measure of safety
Time Frame: Up to 7 weeks
|
Up to 7 weeks
|
|
Part C: Systolic and diastolic blood pressure as a measure of safety
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
|
Part A: Heart rate as a measure of safety
Time Frame: Up to 9 weeks
|
Up to 9 weeks
|
|
Part B: Heart rate as a measure of safety
Time Frame: Up to 7 weeks
|
Up to 7 weeks
|
|
Part C: Heart rate as a measure of safety
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
|
Part A: Temperature as a measure of safety
Time Frame: Up to 9 weeks
|
Up to 9 weeks
|
|
Part B: Temperature as a measure of safety
Time Frame: Up to 7 weeks
|
Up to 7 weeks
|
|
Part C: Temperature as a measure of safety
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
|
Part A: Respiratory rate as a measure of safety
Time Frame: Up to 9 weeks
|
Up to 9 weeks
|
|
Part B: Respiratory rate as a measure of safety
Time Frame: Up to 7 weeks
|
Up to 7 weeks
|
|
Part C: Respiratory rate as a measure of safety
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
|
Part A: 12-lead electrocardiogram (ECG) as a measure of safety
Time Frame: Up to 9 weeks
|
All scheduled ECGs will be performed after the subject has rested quietly for at least 5 minutes in a supine position.
|
Up to 9 weeks
|
Part B: 12-lead ECG as a measure of safety
Time Frame: Up to 7 weeks
|
All scheduled ECGs will be performed after the subject has rested quietly for at least 5 minutes in a supine position.
|
Up to 7 weeks
|
Part C: 12-lead ECG as a measure of safety
Time Frame: Up to 8 weeks
|
Up to 8 weeks
|
|
Part A: Composite of hematology parameters as a measure of safety
Time Frame: Up to 9 weeks
|
The following hematology parameters will be measured: hemoglobin, Hematocrit, Red blood cell (RBC) count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Platelet count, white blood cell (WBC) count, Total neutrophils (Absolute), Eosinophils (Absolute), Monocytes (Absolute), Basophils (Absolute), and Lymphocytes (Absolute).
|
Up to 9 weeks
|
Part B: Composite of hematology parameters as a measure of safety
Time Frame: Up to 7 weeks
|
The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, MCV, MCH, Platelet count, WBC count, Total neutrophils (Absolute), Eosinophils (Absolute), Monocytes (Absolute), Basophils (Absolute), and Lymphocytes (Absolute).
|
Up to 7 weeks
|
Part C: Composite of hematology parameters as a measure of safety
Time Frame: Up to 8 weeks
|
The following hematology parameters will be measured: Hemoglobin, Hematocrit, RBC count, MCV, MCH, Platelet count, WBC count, Total neutrophils (Absolute), Eosinophils (Absolute), Monocytes (Absolute), Basophils (Absolute), and Lymphocytes (Absolute).
|
Up to 8 weeks
|
Part A: Composite of chemistry parameters as a measure of safety
Time Frame: Up to 9 weeks
|
The following chemistry parameters will be measured: Blood Urea nitrogen (BUN), Uric Acid, Creatinine, Glucose, Calcium, Sodium, Potassium, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Total Bilirubin, Alkaline phosphatase (ALP), Total albumin, Total protein, Total bilirubin and Direct bilirubin.
|
Up to 9 weeks
|
Part B: Composite of chemistry parameters as a measure of safety
Time Frame: Up to 7 weeks
|
The following chemistry parameters will be measured: BUN, Uric Acid, Creatinine, Glucose, Calcium, Sodium, Potassium, AST, ALT, ALP, Total albumin, Total protein, Total bilirubin and Direct bilirubin.
|
Up to 7 weeks
|
Part C: Composite of chemistry parameters as a measure of safety
Time Frame: Up to 8 weeks
|
The following chemistry parameters will be measured: BUN, Uric Acid, Creatinine, Glucose, Calcium, Sodium, Potassium, AST, ALT, ALP, Total albumin, Total protein, Total bilirubin and Direct bilirubin.
|
Up to 8 weeks
|
Part A: Composite of urinalysis parameters as a measure of safety
Time Frame: Up to 6 weeks
|
The following urinalysis parameters will be measured: power of hydrogen (pH), Glucose, Protein, Blood, Ketones by dipstick; specific gravity and Microscopy (if blood or protein is abnormal)
|
Up to 6 weeks
|
Part B: Composite of urinalysis parameters as a measure of safety
Time Frame: Up to 4 weeks
|
The following urinalysis parameters will be measured: pH, Glucose, Protein, Blood, Ketones by dipstick; specific gravity and Microscopy (if blood or protein is abnormal)
|
Up to 4 weeks
|
Part C: Composite of urinalysis parameters as a measure of safety
Time Frame: Up to 4 weeks
|
The following urinalysis parameters will be measured: pH, Glucose, Protein, Blood, Ketones by dipstick; specific gravity and Microscopy (if blood or protein is abnormal)
|
Up to 4 weeks
|
Part A, B and C: Spirometry measurement as a measure of safety
Time Frame: Screening and Day 1 (Pre-dose and 30 minute (min) post-dose)
|
Screening and Day 1 (Pre-dose and 30 minute (min) post-dose)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part A and C: Plasma concentrations of GSK2269557
Time Frame: Pre-dose, 5 min and 30 min, 1 hour (h), 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Pre-dose, 5 min and 30 min, 1 hour (h), 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Part B: Plasma concentrations of GSK2269557
Time Frame: Day 1: pre-dose, and 5 minute (min) and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Day 1: pre-dose, and 5 minute (min) and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Part A and C: Area under the plasma concentration curve (AUC) from time zero to infinity [AUC(0-infinity)] of GSK2269557 following single dose administration
Time Frame: Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Part A and C: AUC from time zero to the time of last quantifiable concentration [AUC(0-t)] of GSK2269557 following single dose administration
Time Frame: Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Part A and C: maximum observed plasma concentration (Cmax)
Time Frame: Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Part A and C: Time to maximum observed concentration (tmax) of GSK2269557 following single dose administration
Time Frame: Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Part A and C: Terminal half life (t1/2) of GSK2269557 following single dose administration
Time Frame: Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Part A and C: concentration at trough (Ctrough) of GSK2269557 following single dose administration
Time Frame: Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Part B: AUC(0-infinity) of GSK2269557 following repeat dose administration
Time Frame: Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Part B: AUC(0-t) of GSK2269557 following repeat dose administration
Time Frame: Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Part B: Cmax of GSK2269557 following repeat dose administration
Time Frame: Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Part B: tmax of GSK2269557 following repeat dose administration
Time Frame: Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Part B: t1/2 of GSK2269557 following repeat dose administration
Time Frame: Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Part B: Ctrough of GSK2269557 following repeat dose administration
Time Frame: Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Day 1: pre-dose, and 5 min and 24 h post-dose (Day 2 pre-dose); Days 6, 7, 8, 9: pre-dose; Day 10: pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h and 24 h post-dose (Day 11), Day 12: 48 h post-dose; and Day 13: 72 h post-dose
|
Part C: AUC from time zero to 24 hours post dose [AUC(0-24)] for GSK2269557 following the inhaled route with and without charcoal
Time Frame: Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Pre-dose and 5 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h post dose of each treatment period
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201544
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.
Clinical Trials on Pulmonary Disease, Chronic Obstructive
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on GSK2269557 ELLIPTA DPI
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveJapan
-
GlaxoSmithKlineCompletedAsthmaCanada, United States
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited States
-
GlaxoSmithKlineCompletedAsthmaUnited States, Argentina, Japan, Poland, Canada, Russian Federation, Spain, Germany, Hungary, South Africa, Italy, Mexico, Romania, Bulgaria, China, Lithuania
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveGermany
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompleted