Trial Outcomes & Findings for First Time in Human (FTIH) Safety and Pharmacokinetics (PK) Study of GSK3036656 in Healthy Subjects (NCT NCT03075410)
NCT ID: NCT03075410
Last Updated: 2019-04-19
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above. Safety Population comprised of all randomized participants who received at least one dose of study medication.
COMPLETED
PHASE1
30 participants
Up to 12 weeks
2019-04-19
Participant Flow
This was a double blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics (PK) of single and repeat doses of GSK3036656 in healthy adult participants. The study was conducted at 1 center in United Kingdom from 02-April-2017 to 04-August-2017. Part A was a crossover design, Part B was a parallel group design..
20 participants screened, 8 were screen failures (SF). 9 were randomized at the beginning of Part A. During Part A, 2 of the 3 participants who withdrew were replaced, hence 11 randomized. 30 participants screened, 7 were SF, 4 passed screening but were kept in reserve, hence 19 randomized in Part B.
Participant milestones
| Measure |
PartA - Placebo/15 mg/25 mg/5 mg (Fed)
Participants received matching placebo to GSK3036656 5 milligrams (mg) followed by GSK3036656 15 mg followed by GSK3036656 25 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
|
PartA - Placebo/15 mg/25 mg/Placebo
Participants received matching placebo to GSK3036656 5 mg followed by GSK3036656 15 mg followed by GSK3036656 25 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
|
PartA - 5 mg/Placebo/25 mg/5 mg (Fed)
Participants received SK3036656 5 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 25 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
|
PartA - 5 mg/Placebo/25 mg/Placebo
Participants received SK3036656 5 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 25 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
|
PartA - 5 mg/15 mg/Placebo/5 mg (Fed)
Participants received GSK3036656 5 mg followed by GSK3036656 15 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
|
PartA - 5 mg/15 mg/Placebo/Placebo
Participants received GSK3036656 5 mg followed by GSK3036656 15 mg followed by matching placebo to GSK3036656 5 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
|
Part B-Placebo
Participants received matching placebo to active GSK3036656 5 mg / 15mg capsules orally once daily for 14 days.
|
Part B-Repeat GSK3036656 5 mg
Participants received repeat dosing of GSK3036656 5 mg capsules orally once daily for 14 days.
|
Part B-Repeat GSK3036656 15 mg
Participants received repeat dosing of GSK3036656 15 mg capsules orally once daily for 14 days.
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Part A-Period 1 (14 Days)
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Part A-Period 1 (14 Days)
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Part A-Period 1 (14 Days)
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Part A-Washout Period 1 (14 Days)
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Part A-Washout Period 1 (14 Days)
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Part A-Period 2 (14 Days)
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Part A-Period 2 (14 Days)
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Part A-Washout Period 2 (14 Days)
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Part A-Washout Period 2 (14 Days)
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Part A-Period 3 (14 Days)
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Part A-Period 3 (14 Days)
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Part A-Period 3 (14 Days)
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Part A-Washout Period 3 (14 Days)
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Part A-Washout Period 3 (14 Days)
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Part A-Washout Period 3 (14 Days)
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Part A-Period 4 (14 Days)
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Part A-Period 4 (14 Days)
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Part A-Period 4 (14 Days)
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Part B (up to 28 Days)
STARTED
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Part B (up to 28 Days)
COMPLETED
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Part B (up to 28 Days)
NOT COMPLETED
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Reasons for withdrawal
| Measure |
PartA - Placebo/15 mg/25 mg/5 mg (Fed)
Participants received matching placebo to GSK3036656 5 milligrams (mg) followed by GSK3036656 15 mg followed by GSK3036656 25 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
|
PartA - Placebo/15 mg/25 mg/Placebo
Participants received matching placebo to GSK3036656 5 mg followed by GSK3036656 15 mg followed by GSK3036656 25 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
|
PartA - 5 mg/Placebo/25 mg/5 mg (Fed)
Participants received SK3036656 5 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 25 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
|
PartA - 5 mg/Placebo/25 mg/Placebo
Participants received SK3036656 5 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 25 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
|
PartA - 5 mg/15 mg/Placebo/5 mg (Fed)
Participants received GSK3036656 5 mg followed by GSK3036656 15 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
|
PartA - 5 mg/15 mg/Placebo/Placebo
Participants received GSK3036656 5 mg followed by GSK3036656 15 mg followed by matching placebo to GSK3036656 5 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
|
Part B-Placebo
Participants received matching placebo to active GSK3036656 5 mg / 15mg capsules orally once daily for 14 days.
|
Part B-Repeat GSK3036656 5 mg
Participants received repeat dosing of GSK3036656 5 mg capsules orally once daily for 14 days.
|
Part B-Repeat GSK3036656 15 mg
Participants received repeat dosing of GSK3036656 15 mg capsules orally once daily for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A-Period 2 (14 Days)
Personal reasons
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1
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0
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1
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0
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0
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0
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0
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0
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0
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Part A-Period 3 (14 Days)
Reaction to ECG tabs causing a rash
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1
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0
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0
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0
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0
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0
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0
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0
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0
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Baseline Characteristics
First Time in Human (FTIH) Safety and Pharmacokinetics (PK) Study of GSK3036656 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Part A - Placebo/15 mg/25 mg/5 mg (Fed)
n=3 Participants
Participants received matching placebo to GSK3036656 5 mg followed by GSK3036656 15 mg followed by GSK3036656 25 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
|
Part A - Placebo/15 mg/25 mg/Placebo
n=1 Participants
Participants received matching placebo to GSK3036656 5 mg followed by GSK3036656 15 mg followed by GSK3036656 25 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
|
Part A - 5 mg/Placebo/25 mg/5 mg (Fed)
n=3 Participants
Participants received SK3036656 5 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 25 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
|
Part A - 5 mg/Placebo/25 mg/Placebo
n=1 Participants
Participants received SK3036656 5 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 25 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
|
Part A - 5 mg/15 mg/Placebo/5 mg (Fed)
n=2 Participants
Participants received GSK3036656 5 mg followed by GSK3036656 15 mg followed by matching placebo to GSK3036656 5 mg followed by GSK3036656 5 mg (fed) capsules orally for 14 Days.
|
Part A - 5 mg/15 mg/Placebo/Placebo
n=1 Participants
Participants received GSK3036656 5 mg followed by GSK3036656 15 mg followed by matching placebo to GSK3036656 5 mg followed by matching placebo to GSK3036656 5 mg capsules orally for 14 Days.
|
Part B-Placebo
n=4 Participants
Participants received matching placebo to active GSK3036656 5 mg / 15mg capsules orally once daily for 14 days.
|
Part B-Repeat GSK3036656 5 mg
n=7 Participants
Participants received repeat dosing of GSK3036656 5 mg capsules orally once daily for 14 days.
|
Part B-Repeat GSK3036656 15 mg
n=8 Participants
Participants received repeat dosing of GSK3036656 15 mg capsules orally once daily for 14 days.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.7 Years
STANDARD_DEVIATION 5.03 • n=93 Participants
|
25 Years
STANDARD_DEVIATION NA • n=4 Participants
|
26.3 Years
STANDARD_DEVIATION 2.52 • n=27 Participants
|
28.0 Years
STANDARD_DEVIATION NA • n=483 Participants
|
34.0 Years
STANDARD_DEVIATION 1.41 • n=36 Participants
|
50.0 Years
STANDARD_DEVIATION NA • n=10 Participants
|
30.3 Years
STANDARD_DEVIATION 9.43 • n=115 Participants
|
31.9 Years
STANDARD_DEVIATION 6.26 • n=40 Participants
|
35.1 Years
STANDARD_DEVIATION 7.88 • n=8 Participants
|
32.5 Years
STANDARD_DEVIATION 7.39 • n=62 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
7 Participants
n=40 Participants
|
8 Participants
n=8 Participants
|
29 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Asian-South Asian Heritage
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Black/ African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
5 Participants
n=40 Participants
|
8 Participants
n=8 Participants
|
23 Participants
n=62 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=62 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Population for Part A
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above. Safety Population comprised of all randomized participants who received at least one dose of study medication.
Outcome measures
| Measure |
Part A-Matching Placebo
n=9 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 Participants
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Non-serious Adverse Events (nSAE) and Serious Adverse Events (SAEs) for Part A
nSAE
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Non-serious Adverse Events (nSAE) and Serious Adverse Events (SAEs) for Part A
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety Population for Part B
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above.
Outcome measures
| Measure |
Part A-Matching Placebo
n=4 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=7 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=8 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
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Number of Participants With nSAE and SAEs for Part B
nSAE
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With nSAE and SAEs for Part B
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
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—
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.
12-lead ECGs were collected during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) intervals. At each time point at which triplicate ECGs were required, three individual ECG tracings were obtained as closely as possible in succession, but no more than 2 to 5 minutes apart. ECG findings were categorized as normal, abnormal not clinically significant (A-NCS) and abnormal clinically significant (A-CS). Only A-NCS and A-CS worst case post-Baseline values have been presented. Only those participants with data available at the indicated time point were analyzed.
Outcome measures
| Measure |
Part A-Matching Placebo
n=9 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 Participants
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings for Part A
A-NCS
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings for Part A
A-CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety Population for Part A
12-lead ECGs were collected during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT interval and QTcF intervals. At each time point at which triplicate ECGs were required, three individual ECG tracings were obtained as closely as possible in succession, but no more than 2 to 5 minutes apart. ECG findings were categorized as normal, A-NCS and A-CS. Only A-NCS and A-CS worst case post-Baseline values have been presented.
Outcome measures
| Measure |
Part A-Matching Placebo
n=4 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=7 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=8 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Subjects With Clinically Relevant Changes in ECG in Part B
A-NCS
|
1 Participants
|
3 Participants
|
3 Participants
|
—
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—
|
|
Number of Subjects With Clinically Relevant Changes in ECG in Part B
A-CS
|
0 Participants
|
0 Participants
|
0 Participants
|
—
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—
|
PRIMARY outcome
Timeframe: 25 hours for each periodPopulation: Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.
Continuous cardiac telemetry was performed from approximately 1 hour pre-dose to 24 hours post dosing . Number of participants who had abnormal findings upon cardiac telemetry assessment have been presented.
Outcome measures
| Measure |
Part A-Matching Placebo
n=9 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 Participants
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Cardiac Telemetry Findings for Part A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 25 hours for each periodPopulation: Safety Population for Part B
Continuous cardiac telemetry was performed from approximately 1 hour pre-dose to 24 hours post dosing . Number of participants who had abnormal findings upon cardiac telemetry assessment have been presented.
Outcome measures
| Measure |
Part A-Matching Placebo
n=4 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=7 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=8 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Cardiac Telemetry Findings for Part B
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.
SBP and DBP were assessed in supine position with a completely automated device. Measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). The PCI range for SBP was less than 85 mmHg (lower) and greater than 160 mmHg (upper) while that for DBP was less than 45 mmHg (lower) and greater than 100 mmHg (upper).
Outcome measures
| Measure |
Part A-Matching Placebo
n=9 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 Participants
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance (PCI) for Part A
SBP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance (PCI) for Part A
DBP
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety Population for Part B
SBP and DBP were assessed in supine position with a completely automated device. Measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). The PCI range for SBP was less than 85 mmHg (lower) and greater than 160 mmHg (upper) while that for DBP was less than 45 mmHg (lower) and greater than 100 mmHg (upper).
Outcome measures
| Measure |
Part A-Matching Placebo
n=4 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=7 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=8 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Parameters SBP and DBP of PCI for Part B
SBP
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Sign Parameters SBP and DBP of PCI for Part B
DBP
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.
Heart rate was assessed in supine position with a completely automated device. Measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). The PCI range for heart was less than 40 bpm (lower) and greater than 110 bpm (upper).
Outcome measures
| Measure |
Part A-Matching Placebo
n=9 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 Participants
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Parameter Heart Rate of PCI for Part A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety Population for Part B
Heart rate was assessed in supine position with a completely automated device. Measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). The PCI range for heart was less than 40 bpm (lower) and greater than 110 bpm (upper).
Outcome measures
| Measure |
Part A-Matching Placebo
n=4 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=7 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=8 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Parameter Heart Rate of PCI for Part B
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 6 weeksPopulation: Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.
Number of participants with temperature data of PCI have been presented.
Outcome measures
| Measure |
Part A-Matching Placebo
n=9 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 Participants
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Parameter Temperature of PCI for Part A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety Population for Part B
Number of participants with temperature data of PCI have been presented.
Outcome measures
| Measure |
Part A-Matching Placebo
n=4 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=7 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=8 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Parameter Temperature of PCI for Part B
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.
Blood samples were collected for the assessment of clinical chemistry parameters namely blood urea nitrogen (BUN), creatinine, glucose, cholesterol, potassium, sodium, calcium, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase, triglycerides, total and direct bilirubin, total protein, albumin and troponin. Only categories with PCI values have been presented, therefore only AST is presented.
Outcome measures
| Measure |
Part A-Matching Placebo
n=9 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 Participants
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Parameters of PCI for Part A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety Population for Part B
Blood samples were collected for the assessment of clinical chemistry parameters namely BUN, creatinine, glucose, cholesterol, potassium, sodium, calcium, AST, ALT, alkaline phosphatase, triglycerides, total and direct bilirubin, total protein, albumin and troponin. Only categories with PCI values have been presented.
Outcome measures
| Measure |
Part A-Matching Placebo
n=4 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=7 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=8 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Parameters of PCI for Part B
ALT
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Chemistry Parameters of PCI for Part B
AST
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.
Blood samples were collected for the assessment of hematology parameters platelet count, red blood cell count, hemoglobin, hematocrit, reticulocytes, mean corpuscle volume, mean corpuscular hemoglobin, neutrophils, lymphocytes, monocytes, basophils and eosinophils. Only categories with PCI values have been presented.
Outcome measures
| Measure |
Part A-Matching Placebo
n=9 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 Participants
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Hematology Parameters of PCI for Part A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety Population for Part B
Blood samples were collected for the assessment of hematology parameters platelet count, red blood cell count, hemoglobin, hematocrit, reticulocytes, mean corpuscle volume, mean corpuscular hemoglobin, neutrophils, lymphocytes, monocytes, basophils and eosinophils. Only categories with PCI values have been presented.
Outcome measures
| Measure |
Part A-Matching Placebo
n=4 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=7 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=8 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Hematology Parameters of PCI for Part B
Leukocytes
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Hematology Parameters of PCI for Part B
Neutrophils
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 72 hours post-dosePopulation: Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.
Urinalysis included dipstick urine test which was used to screen for glucose, ketones, occult blood and protein up to 72 hours post dose. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose, ketones, occult blood and protein can be read as negative, trace, trace-intact, trace-lysed,1+ and 2+ indicating proportional concentrations in the urine sample. Only categories with non-negative values have been presented. Only those participants with data available the indicated time points were analyzed.
Outcome measures
| Measure |
Part A-Matching Placebo
n=9 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 Participants
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
Day -1, Ketone, Trace
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
Day -1, Occult blood, 1+
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
Day -1, Occult blood, 2+
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
Day -1, Occult blood, trace-intact
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
Day -1, Occult blood, trace-lysed
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
Day -1, Protein, Trace
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
24 hours, Ketones, 2+
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
24 hours, Occult blood, 2+
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
24 hours, Occult blood, trace-intact
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
24 hours, Occult blood, trace-lysed
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
72 hours, Ketone, Trace
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
72 hours, Occult blood, 1+
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
72 hours, Occult blood, trace-intact
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
72 hours, Occult blood, trace-lysed
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part A
72 hours, Protein, Trace
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 72 hours post-dosePopulation: Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 72 hours in Part A. Only those participants with data available at the indicated time points were analyzed.
Outcome measures
| Measure |
Part A-Matching Placebo
n=9 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 Participants
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part A
pH at Day -1
|
6.08 pH
Standard Deviation 0.469
|
6.00 pH
Standard Deviation 0.548
|
5.50 pH
Standard Deviation 0.548
|
5.92 pH
Standard Deviation 0.492
|
6.70 pH
Standard Deviation 1.483
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part A
pH at 24 hours
|
6.04 pH
Standard Deviation 0.498
|
6.50 pH
Standard Deviation 0.447
|
5.83 pH
Standard Deviation 0.258
|
6.08 pH
Standard Deviation 0.204
|
6.80 pH
Standard Deviation 1.095
|
|
Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part A
pH at 72 hours
|
6.46 pH
Standard Deviation 0.753
|
6.00 pH
Standard Deviation 1.095
|
5.92 pH
Standard Deviation 0.492
|
6.42 pH
Standard Deviation 0.665
|
7.30 pH
Standard Deviation 0.671
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety Population for Part B
Urinalysis included dipstick urine test which was used to screen for glucose, ketones, occult blood and protein up to 14 days post dose The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose, ketones, occult blood and protein can be read as negative, trace, trace-intact, trace-lysed, 1+ and 2+ indicating proportional concentrations in the urine sample. Only categories with non-negative values have been presented. Only those participants available at the specified time points were analyzed represented by n=x in the category titles. Period 1 = Cohort 1 in Part B, Period 2 = Cohort 2 in Part B.
Outcome measures
| Measure |
Part A-Matching Placebo
n=4 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=7 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=8 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Day 6,Occult blood,Trace-lysed,n=2,0,8
|
0 Participants
|
—
|
2 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Day 10, Ketones, Trace,n=2,0,8
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Follow up (week 8), Occult blood, n=4,7,8
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Day -1, Ketones, Trace,n=2,7,0
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Day -1, Occult blood,Trace-intact,n=2,7,0
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Day 14, Ketones, Trace,n=2,7,0
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Day 14, protein, 1+,n=2,7,0
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Day -1,Occult blood,Trace-intact,n=2,0,8
|
1 Participants
|
—
|
2 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Day 6,Occult blood,Trace-intact,n=2,0,8
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Day 14, Protein, 2+,n=2,0,8
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Follow-up (week 8), Ketones, n=4,7,8
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Parameters for Part B
Follow-up(week 8),Occult blood,Trace-lysed,n=4,7,8
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Safety Population for Part B
Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 8 weeks in Part B. Only those participants available at the specified time points were analyzed represented by n=x in the category titles. Period 1 = Cohort 1 in Part B, Period 2 = Cohort 2 in Part B.
Outcome measures
| Measure |
Part A-Matching Placebo
n=4 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=7 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=8 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Period 1, Day -1, n=2, 7, 0
|
6.25 pH
Standard Deviation 0.354
|
6.71 pH
Standard Deviation 0.906
|
—
|
—
|
—
|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Period 1, Day 10, n=2, 7, 0
|
6.25 pH
Standard Deviation 0.354
|
6.14 pH
Standard Deviation 0.244
|
—
|
—
|
—
|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Period 2, Day 10, n=2, 0, 8
|
6.00 pH
Standard Deviation 0.000
|
—
|
6.38 pH
Standard Deviation 0.354
|
—
|
—
|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Period 2, Day 14, n=2, 0, 8
|
6.00 pH
Standard Deviation 0.000
|
—
|
6.38 pH
Standard Deviation 0.582
|
—
|
—
|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Period 1, Day 4, n= 2, 7, 0
|
6.25 pH
Standard Deviation 0.354
|
5.79 pH
Standard Deviation 0.393
|
—
|
—
|
—
|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Period 1, Day 6, n=2, 7, 0
|
6.25 pH
Standard Deviation 0.354
|
6.43 pH
Standard Deviation 0.535
|
—
|
—
|
—
|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Period 1, Day 14, n=2, 7, 0
|
6.75 pH
Standard Deviation 0.354
|
7.00 pH
Standard Deviation 0.957
|
—
|
—
|
—
|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Period 2, Day -1, n=2, 0, 8
|
6.50 pH
Standard Deviation 0.707
|
—
|
6.81 pH
Standard Deviation 0.594
|
—
|
—
|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Period 2, Day 4, n=2, 0, 8
|
5.50 pH
Standard Deviation 0.707
|
—
|
6.25 pH
Standard Deviation 0.378
|
—
|
—
|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Period 2, Day 6, n=2, 0, 8
|
6.50 pH
Standard Deviation 0.000
|
—
|
6.69 pH
Standard Deviation 0.458
|
—
|
—
|
|
Urine pH Analysis by Dipstick Method for Part B
pH, Follow-up (week 8), n=4, 7, 8
|
6.63 pH
Standard Deviation 0.750
|
6.29 pH
Standard Deviation 0.488
|
6.88 pH
Standard Deviation 0.744
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 Ethylenediaminetetraacetic acid (EDTA) tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. PK population comprised of participants in the Safety population who administered at least one dose of active treatment and had at least one evaluable PK sample.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) Following Single Dose Administration of GSK3036656 for Part A
|
771.0468 hour*nanograms/milliliter
Geometric Coefficient of Variation 26.0
|
3252.9152 hour*nanograms/milliliter
Geometric Coefficient of Variation 24.1
|
5686.4151 hour*nanograms/milliliter
Geometric Coefficient of Variation 11.4
|
782.7766 hour*nanograms/milliliter
Geometric Coefficient of Variation 18.1
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Cmax will be derived from the PK samples collected at the indicated time points Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
AUC From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK3036656 Following Single Dose Administration for Part A
|
1404.5416 hour*nanograms/milliliter
Geometric Coefficient of Variation 29.9
|
3796.1488 hour*nanograms/milliliter
Geometric Coefficient of Variation 19.8
|
6557.7764 hour*nanograms/milliliter
Geometric Coefficient of Variation 13.8
|
1450.7468 hour*nanograms/milliliter
Geometric Coefficient of Variation 9.4
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Drug Concentration (Cmax) of GSK3036656 Following Single Dose Administration for Part A
|
49.06 nanograms/milliliter
Geometric Coefficient of Variation 30.5
|
177.61 nanograms/milliliter
Geometric Coefficient of Variation 23.1
|
207.38 nanograms/milliliter
Geometric Coefficient of Variation 18.5
|
47.37 nanograms/milliliter
Geometric Coefficient of Variation 23.5
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3036656 Following Single Dose Administration for Part A
|
1.250 hours
Interval 0.5 to 1.5
|
1.000 hours
Interval 0.5 to 2.0
|
0.875 hours
Interval 0.75 to 2.0
|
2.000 hours
Interval 1.0 to 4.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of GSK3036656 Following Single Dose Administration for Part A
|
38.3230 hours
Interval 25.632 to 70.97
|
28.4128 hours
Interval 24.462 to 32.497
|
47.9680 hours
Interval 35.996 to 67.36
|
32.4248 hours
Interval 30.449 to 46.455
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1Population: PK Population for Part B
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1. The actual date and time of each blood sample collection was recorded. Results presented are for Day 1.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
AUC[0-t] Following Repeated Dose Administration of GSK3036656 for Part B
|
485.5625 hour*nanograms/milliliter
Geometric Coefficient of Variation 12.3
|
1891.0416 hour*nanograms/milliliter
Geometric Coefficient of Variation 9.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14Population: PK Population for Part B
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14The actual date and time of each blood sample collection was recorded. Results presented are for Day 14.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
AUC From Time Zero During a Dosing Interval of Duration Tau (AUC[0-tau]) of GSK3036656 Following Repeated Dose Administration for Part B
|
1392.2221 hour*nanograms/milliliter
Geometric Coefficient of Variation 12.5
|
4461.2565 hour*nanograms/milliliter
Geometric Coefficient of Variation 23.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13Population: PK Population for Part B
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13. The actual date and time of each blood sample collection was recorded.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Cmax of GSK3036656 Following Repeated Dose Administration for Part B
Day 14
|
97.04 nanograms/milliliter
Geometric Coefficient of Variation 19.8
|
309.55 nanograms/milliliter
Geometric Coefficient of Variation 20.2
|
—
|
—
|
—
|
|
Cmax of GSK3036656 Following Repeated Dose Administration for Part B
Day 1
|
48.40 nanograms/milliliter
Geometric Coefficient of Variation 33.6
|
178.79 nanograms/milliliter
Geometric Coefficient of Variation 32.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13Population: PK Population for Part B
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13. The actual date and time of each blood sample collection was recorded.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Tmax of GSK3036656 Following Repeat Dose Administration for Part B
Day 14
|
0.7500 hours
Interval 0.5 to 1.5
|
0.7500 hours
Interval 0.5 to 1.5
|
—
|
—
|
—
|
|
Tmax of GSK3036656 Following Repeat Dose Administration for Part B
Day 1
|
1.0000 hours
Interval 0.5 to 3.0
|
0.7500 hours
Interval 0.5 to 1.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14.Population: PK Population for Part B
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14. The actual date and time of each blood sample collection was recorded. Results presented are for Day 14.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
t1/2 of GSK3036656 Following Repeated Dose Administration for Part B
|
40.1802 hours
Interval 30.843 to 66.636
|
34.5109 hours
Interval 24.758 to 54.625
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. For the food effect assessment, the selected dose was given with a high fat meal.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
AUC (0-t) of GSK3036656 Following Single Dose Administration in Fed Condition in Part A
|
771.0468 hours*nanograms/milliliter
Geometric Coefficient of Variation 26.0
|
3252.9152 hours*nanograms/milliliter
Geometric Coefficient of Variation 24.1
|
5686.4151 hours*nanograms/milliliter
Geometric Coefficient of Variation 11.4
|
782.7766 hours*nanograms/milliliter
Geometric Coefficient of Variation 18.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. For the food effect assessment, the selected dose was given with a high fat meal.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
AUC (0-infinity) of GSK3036656 Following Single Dose Administration in Fed Condition in Part A
|
1404.5416 hours*nanograms/milliliter
Geometric Coefficient of Variation 29.9
|
3796.1488 hours*nanograms/milliliter
Geometric Coefficient of Variation 19.8
|
6557.7764 hours*nanograms/milliliter
Geometric Coefficient of Variation 13.8
|
1450.7468 hours*nanograms/milliliter
Geometric Coefficient of Variation 9.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. For the food effect assessment, the selected dose was given with a high fat meal.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Cmax of GSK3036656 Following Single Dose Administration in Fed Condition in Part A
|
49.06 nanograms/milliliter
Geometric Coefficient of Variation 30.5
|
177.61 nanograms/milliliter
Geometric Coefficient of Variation 23.1
|
207.38 nanograms/milliliter
Geometric Coefficient of Variation 18.5
|
35.54 nanograms/milliliter
Geometric Coefficient of Variation 23.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. For the food effect assessment, the selected dose was given with a high fat meal.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
t1/2 of GSK3036656 Following Single Dose Administration in Fed Condition in Part A
|
38.3230 hours
Interval 25.632 to 70.97
|
28.4128 hours
Interval 24.462 to 32.497
|
47.9680 hours
Interval 35.996 to 67.36
|
32.4248 hours
Interval 30.449 to 46.455
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. For the food effect assessment, the selected dose was given with a high fat meal.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Tmax of GSK3036656 Following Single Dose Administration in Fed Condition in Part A
|
1.250 hours
Interval 0.5 to 1.5
|
1.000 hours
Interval 0.5 to 2.0
|
0.875 hours
Interval 0.75 to 2.0
|
2.000 hours
Interval 1.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14Population: PK Population for Part B
AUC Ro was calculated as Day 14 AUC(0-tau)/Day 1 AUC(0-t), where t and tau= 24 hours.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Observed Accumulation Ratio Based on AUC (AUC [Ro]) of GSK3036656 in Part B
|
2.8672 Ratio of AUC
Geometric Coefficient of Variation 9.1
|
2.3592 Ratio of AUC
Geometric Coefficient of Variation 21.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14Population: PK Population for Part B
Rcmax was calculated as Day 14 Cmax/Day 1 Cmax. Statistics has been presented on geometric least square means.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Observed Accumulation Ratio Based on Cmax (RCmax) of GSK3036656 in Part B
|
2.0052 Ratio of Cmax
Geometric Coefficient of Variation 24.3
|
1.7313 Ratio of Cmax
Geometric Coefficient of Variation 26.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14Population: PK Population for Part B
Rss was calculated as Day 14 AUC (0-tau)/Day 1 AUC (0-inf). It was not possible to calculate AUC(0-inf) on Day 1 for the repeat dosing period, therefore it was not possible to calculate the (Rss).Na indicates data was not available.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Steady State Ratio (Rss) of GSK3036656 in Part B
|
NA Ratio of AUC
Geometric Coefficient of Variation NA
It was not possible to calculate AUC(0-inf) on Day 1 for the repeat dosing period, therefore it was not possible to calculate the steady state ratio (Rss).
|
NA Ratio of AUC
Geometric Coefficient of Variation NA
It was not possible to calculate AUC(0-inf) on Day 1 for the repeat dosing period, therefore it was not possible to calculate the steady state ratio (Rss).
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (24 hours), Day 12 (Pre-dose ), Day 13 (Pre-dose ), Day 14 (Pre-dose), Day 14 (24 hours)Population: PK Population for Part B
Blood samples for the analysis of Ctau were collected at Day 1 (24 hours), Day 12 (Pre-dose ), Day 13 (Pre-dose ), Day 14 (Pre-dose), Day 14 (24 hours). Ctau samples collected were used to assess attainment of steady state. Statistics has been presented on geometric least square means.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Trough Plasma Concentrations at the End of the Dosing Interval (Ctau) of GSK3036656 Following Repeat Dose Administrations in Part B
Day 1, 24 hours
|
14.32 nanograms/milliliter
Geometric Coefficient of Variation 10.8
|
57.69 nanograms/milliliter
Geometric Coefficient of Variation 10.5
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of the Dosing Interval (Ctau) of GSK3036656 Following Repeat Dose Administrations in Part B
Day 13, Pre-dose
|
41.78 nanograms/milliliter
Geometric Coefficient of Variation 14.5
|
131.77 nanograms/milliliter
Geometric Coefficient of Variation 28.8
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of the Dosing Interval (Ctau) of GSK3036656 Following Repeat Dose Administrations in Part B
Day 14, Pre-dose
|
43.66 nanograms/milliliter
Geometric Coefficient of Variation 15.1
|
139.54 nanograms/milliliter
Geometric Coefficient of Variation 32.5
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of the Dosing Interval (Ctau) of GSK3036656 Following Repeat Dose Administrations in Part B
Day 12, Pre-dose
|
38.31 nanograms/milliliter
Geometric Coefficient of Variation 20.8
|
139.14 nanograms/milliliter
Geometric Coefficient of Variation 21.6
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of the Dosing Interval (Ctau) of GSK3036656 Following Repeat Dose Administrations in Part B
Day 14, 24 hours
|
44.34 nanograms/milliliter
Geometric Coefficient of Variation 14.8
|
139.25 nanograms/milliliter
Geometric Coefficient of Variation 28.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for the analysis of AUC (0-infinity) were collected at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. AUC(0-infinity) following single doses was used for assessment of dose proportionality.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
AUC (0-infinity) as a Measure of Dose Proportionality of GSK3036656 Following Single Dose Administrations for Part A
|
1404.5416 hours*nanograms/milliliter
Geometric Coefficient of Variation 29.9
|
3796.1488 hours*nanograms/milliliter
Geometric Coefficient of Variation 19.8
|
6557.7764 hours*nanograms/milliliter
Geometric Coefficient of Variation 13.8
|
1450.7468 hours*nanograms/milliliter
Geometric Coefficient of Variation 9.4
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for the analysis of AUC (0-t) were collected at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. AUC(0-t) following single doses was used for assessment of dose proportionality.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
AUC (0-t) as a Measure of Dose Proportionality of GSK3036656 Following Single Dose Administrations for Part A
|
771.0468 hours*nanograms/milliliter
Geometric Coefficient of Variation 26.0
|
3252.9152 hours*nanograms/milliliter
Geometric Coefficient of Variation 24.1
|
5686.4151 hours*nanograms/milliliter
Geometric Coefficient of Variation 11.4
|
782.7766 hours*nanograms/milliliter
Geometric Coefficient of Variation 18.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each periodPopulation: PK Population for Part A
Blood samples for the analysis of Cmax were collected at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. Cmax following single doses was used for assessment of dose proportionality.
Outcome measures
| Measure |
Part A-Matching Placebo
n=6 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 Participants
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=5 Participants
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Cmax as a Measure of Dose Proportionality of GSK3036656 Following Single Dose Administrations for Part A
|
49.06 hours*nanograms/milliliter
Geometric Coefficient of Variation 30.5
|
177.61 hours*nanograms/milliliter
Geometric Coefficient of Variation 23.1
|
207.38 hours*nanograms/milliliter
Geometric Coefficient of Variation 18.5
|
47.37 hours*nanograms/milliliter
Geometric Coefficient of Variation 23.5
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13Population: PK Population for Part B
Blood samples for the assessment of AUC (0-tau) were collected at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13. AUC (0-tau) following repeat doses was used for assessment of dose proportionality.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
AUC (0-tau) as a Measure of Dose Proportionality of GSK3036656 Following Repeat Dose Administrations for Part B
|
1392.2221 hours*nanograms/milliliter
Geometric Coefficient of Variation 12.5
|
4461.2565 hours*nanograms/milliliter
Geometric Coefficient of Variation 23.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13Population: PK Population for Part B
Blood samples for the assessment of Cmax were collected at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13. Cmax following repeat doses was used for assessment of dose proportionality.
Outcome measures
| Measure |
Part A-Matching Placebo
n=7 Participants
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=8 Participants
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
|---|---|---|---|---|---|
|
Cmax as a Measure of Dose Proportionality of GSK3036656 Following Repeat Dose Administrations for Part B
Day 1
|
48.40 nanograms/milliliter
Geometric Coefficient of Variation 33.6
|
178.79 nanograms/milliliter
Geometric Coefficient of Variation 32.8
|
—
|
—
|
—
|
|
Cmax as a Measure of Dose Proportionality of GSK3036656 Following Repeat Dose Administrations for Part B
Day 14
|
97.04 nanograms/milliliter
Geometric Coefficient of Variation 19.8
|
309.55 nanograms/milliliter
Geometric Coefficient of Variation 20.2
|
—
|
—
|
—
|
Adverse Events
Part A-Matching Placebo
Part A-GSK3036656 5 mg
Part A-GSK3036656 15 mg
Part A-GSK3036656 25 mg
Part A-GSK3036656 5 mg (Fed)
Part B-Matching Placebo
Part B-GSK3036656 5 mg
Part B-GSK3036656 15 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A-Matching Placebo
n=9 participants at risk
Participants received single dosing of matching placebo to GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 5 mg
n=6 participants at risk
Participants received single dosing of GSK3036656 5 mg capsules orally.
|
Part A-GSK3036656 15 mg
n=6 participants at risk
Participants received single dosing of GSK3036656 15 mg capsules orally.
|
Part A-GSK3036656 25 mg
n=6 participants at risk
Participants received single dosing of GSK3036656 25 mg capsules orally.
|
Part A-GSK3036656 5 mg (Fed)
n=5 participants at risk
Participants received single dosing of GSK3036656 5 mg capsules in the fed state orally.
|
Part B-Matching Placebo
n=4 participants at risk
Participants received matching placebo to active GSK3036656 5 mg / 15mg capsules orally once daily for 14 days.
|
Part B-GSK3036656 5 mg
n=7 participants at risk
Participants received repeat dosing of GSK3036656 5 mg capsules orally once daily for 14 days.
|
Part B-GSK3036656 15 mg
n=8 participants at risk
Participants received repeat dosing of GSK3036656 15 mg capsules orally once daily for 14 days.
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Liver function test increased
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
14.3%
1/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
33.3%
2/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
16.7%
1/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
16.7%
1/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
28.6%
2/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
20.0%
1/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
16.7%
1/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
16.7%
1/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
16.7%
1/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
14.3%
1/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
12.5%
1/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
General disorders
Medical device site reaction
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
14.3%
1/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/9 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/6 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/5 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/4 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
14.3%
1/7 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
0.00%
0/8 • nSAEs and SAEs were collected from Day -1 until 12 weeks in Part A and until 8 weeks in Part B.
Safety Population was used to assess nSAEs and SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER