Trial Outcomes & Findings for GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers (NCT NCT04493684)
NCT ID: NCT04493684
Last Updated: 2025-07-16
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/Standard of care (SOC) to prevent one of the other outcomes mentioned before.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
91 participants
Primary outcome timeframe
Up to 27 weeks
Results posted on
2025-07-16
Participant Flow
This study includes 3 parts. In part 1, 34 participants were randomized. In part 2, 40 participants were randomized. In part 3, 17 participants were randomized.
Participant milestones
| Measure |
Part 1 (Cohort 1) - Single Dose (SD) Placebo (PBO)/GSK3739937 SD 80 mg/GSK3739937 SD 320 mg
Participants received single oral dose of placebo as suspension in Treatment Period 1, followed by single oral dose of 80 milligrams (mg) of GSK3739937 in Treatment Period 2, and followed by single oral dose of 320 mg of GSK3739937 in Treatment Period 3.
|
Part 1 (Cohort 1) - GSK3739937 SD 10 mg/ SD PBO/ GSK3739937 SD 320 mg
Participants received single oral dose of 10 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of placebo as suspension in Treatment Period 2, and followed by single oral dose of 320 mg of GSK3739937 as suspension in Treatment Period 3.
|
Part 1 (Cohort 1) - GSK3739937 SD 10 mg/ GSK3739937 SD 80 mg/SD PBO
Participants received single oral dose of 10 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of 80 mg of GSK3739937 as suspension in Treatment Period 2, and followed by single oral dose of placebo as suspension in Treatment Period 3.
|
Part 1 (Cohort 1) - GSK3739937 SD 800 mg
Participants received single oral dose of 800 mg of GSK3739937 as suspension in Treatment Period 1.
|
Part 1 (Cohort 1) - SD PBO
Participants received single oral dose of Placebo in Treatment Period 1.
|
Part 1 (Cohort 2) - SD PBO/ GSK3739937 SD 160 mg/ GSK3739937 SD 640 mg
Participants received single oral dose of Placebo as suspension in Treatment Period 1, followed by single oral dose of 160 mg of GSK3739937 as suspension in Treatment Period 2, and followed by single oral dose of 640 mg of GSK3739937 as suspension Treatment in Period 3.
|
Part 1 (Cohort 2) - GSK3739937 SD 30mg/ SD PBO/ GSK3739937 SD 640mg
Participants received single oral dose of 30 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of Placebo as suspension in Treatment Period 2, and followed by single oral dose of 640 mg of GSK3739937 as suspension in Treatment Period 3.
|
Part 1 (Cohort 2) - GSK3739937 SD 30 mg/ GSK3739937 SD 160 mg/SD PBO
Participants received single oral dose of 30 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of 160 mg of GSK3739937 in Period 2, and followed by single oral dose of Placebo in Period 3.
|
Part 2 - Once Daily (QD) PBO
Participants received once daily oral doses of Placebo as suspension for 14 days in Treatment Period 1.
|
Part 2 (Cohort 3) - GSK3739937 QD 25 mg
Participants received once daily oral doses of 25 mg of GSK3739937 as suspension for 14 days in Treatment Period 1.
|
Part 2 (Cohort 4) - GSK3739937 QD 50 mg
Participants received once daily oral doses of 50 mg of GSK3739937 as suspension for 14 days in Treatment Period 1.
|
Part 2 (Cohort 5) - GSK3739937 QD 100 mg
Participants received once daily oral doses of 100 mg of GSK3739937 as suspension for 18 days in Treatment Period 1.
|
Part 2 - Once Weekly (QW) PBO
Participants received once weekly oral doses of Placebo as suspension for over 3 weeks in Treatment Period 1.
|
Part 2 (Cohort 6) - GSK3739937 QW 500 mg
Participants received once weekly oral doses of 500 mg of GSK3739937 as suspension for over 3 weeks in Treatment Period 1.
|
Part 3 (Cohort 7) - GSK3739937 PiB Fed/ GSK3739937 Tablet Fed/ GSK3739937 Tablet Fasted
Participants received single dose of 100 mg of powder in bottle (PiB) as oral suspension under moderate fed conditions in Treatment Period 1, followed by single oral dose of 100 mg of GSK3739937 tablet under moderate fed conditions in Treatment Period 2 and followed by single dose of 100 mg of GSK3739937 tablet under fasted conditions in Treatment Period 3.
|
Part 3 (Cohort 7) - GSK3739937 Tablet Fed/ GSK3739937 Tablet Fasted/ GSK3739937 PiB Fed
Participants received single oral dose of 100 mg of GSK3739937 tablet under moderate fed conditions in Treatment Period 1, followed by single oral dose of 100 mg GSK3739937 tablet under fasted conditions in Treatment Period 2 and followed by single dose of 100 mg PiB as oral suspension under moderate fed conditions in Treatment Period 3.
|
Part 3 (Cohort 7) - GSK3739937 Tablet Fasted/ GSK3739937 PiB Fed/ GSK3739937 Tablet Fed
Participants received single oral dose of 100 mg of GSK3739937 tablet under fasted condition in Treatment Period 1, followed by single oral dose of 100 mg PiB as oral suspension under moderate fed conditions in Treatment Period 2 and followed by single oral dose of 100 mg GSK3739937 tablet under fed conditions in Treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 1:Treatment Period 1-Up to 9 Weeks
STARTED
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3
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3
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3
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6
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3
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3
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3
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3
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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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0
|
|
Part 1:Treatment Period 1-Up to 9 Weeks
COMPLETED
|
2
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3
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2
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6
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3
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2
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3
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3
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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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0
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Part 1:Treatment Period 1-Up to 9 Weeks
NOT COMPLETED
|
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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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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0
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0
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0
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Part 1:Treatment Period 2-Up to 9 Weeks
STARTED
|
4
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3
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3
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0
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0
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3
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3
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3
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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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0
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|
Part 1:Treatment Period 2-Up to 9 Weeks
COMPLETED
|
3
|
3
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3
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0
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0
|
3
|
2
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3
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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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0
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Part 1:Treatment Period 2-Up to 9 Weeks
NOT COMPLETED
|
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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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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0
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0
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|
Part 1:Treatment Period 3-Up to 9 Weeks
STARTED
|
4
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3
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3
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0
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0
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4
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3
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3
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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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0
|
|
Part 1:Treatment Period 3-Up to 9 Weeks
COMPLETED
|
3
|
3
|
3
|
0
|
0
|
3
|
3
|
3
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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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0
|
|
Part 1:Treatment Period 3-Up to 9 Weeks
NOT COMPLETED
|
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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1
|
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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0
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0
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0
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|
Part 2:Treatment Period 1-Up to 5 Weeks
STARTED
|
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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9
|
7
|
7
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7
|
3
|
7
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0
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0
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0
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|
Part 2:Treatment Period 1-Up to 5 Weeks
NOT COMPLETED
|
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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0
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0
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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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|
Part 2:Treatment Period 1-Up to 5 Weeks
COMPLETED
|
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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9
|
7
|
7
|
6
|
3
|
7
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0
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0
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0
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|
Part 3:Treatment Period 1-Up to 4 Weeks
STARTED
|
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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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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5
|
6
|
6
|
|
Part 3:Treatment Period 1-Up to 4 Weeks
COMPLETED
|
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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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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5
|
5
|
6
|
|
Part 3:Treatment Period 1-Up to 4 Weeks
NOT COMPLETED
|
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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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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1
|
0
|
|
Part 3:Treatment Period 2-Up to 4 Weeks
STARTED
|
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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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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5
|
5
|
6
|
|
Part 3:Treatment Period 2-Up to 4 Weeks
COMPLETED
|
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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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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5
|
4
|
6
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|
Part 3:Treatment Period 2-Up to 4 Weeks
NOT COMPLETED
|
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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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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1
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0
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Part 3:Treatment Period 3-Up to 4 Weeks
STARTED
|
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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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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5
|
4
|
6
|
|
Part 3:Treatment Period 3-Up to 4 Weeks
COMPLETED
|
0
|
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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0
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0
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0
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0
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0
|
5
|
4
|
6
|
|
Part 3:Treatment Period 3-Up to 4 Weeks
NOT COMPLETED
|
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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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
|
0
|
Reasons for withdrawal
| Measure |
Part 1 (Cohort 1) - Single Dose (SD) Placebo (PBO)/GSK3739937 SD 80 mg/GSK3739937 SD 320 mg
Participants received single oral dose of placebo as suspension in Treatment Period 1, followed by single oral dose of 80 milligrams (mg) of GSK3739937 in Treatment Period 2, and followed by single oral dose of 320 mg of GSK3739937 in Treatment Period 3.
|
Part 1 (Cohort 1) - GSK3739937 SD 10 mg/ SD PBO/ GSK3739937 SD 320 mg
Participants received single oral dose of 10 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of placebo as suspension in Treatment Period 2, and followed by single oral dose of 320 mg of GSK3739937 as suspension in Treatment Period 3.
|
Part 1 (Cohort 1) - GSK3739937 SD 10 mg/ GSK3739937 SD 80 mg/SD PBO
Participants received single oral dose of 10 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of 80 mg of GSK3739937 as suspension in Treatment Period 2, and followed by single oral dose of placebo as suspension in Treatment Period 3.
|
Part 1 (Cohort 1) - GSK3739937 SD 800 mg
Participants received single oral dose of 800 mg of GSK3739937 as suspension in Treatment Period 1.
|
Part 1 (Cohort 1) - SD PBO
Participants received single oral dose of Placebo in Treatment Period 1.
|
Part 1 (Cohort 2) - SD PBO/ GSK3739937 SD 160 mg/ GSK3739937 SD 640 mg
Participants received single oral dose of Placebo as suspension in Treatment Period 1, followed by single oral dose of 160 mg of GSK3739937 as suspension in Treatment Period 2, and followed by single oral dose of 640 mg of GSK3739937 as suspension Treatment in Period 3.
|
Part 1 (Cohort 2) - GSK3739937 SD 30mg/ SD PBO/ GSK3739937 SD 640mg
Participants received single oral dose of 30 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of Placebo as suspension in Treatment Period 2, and followed by single oral dose of 640 mg of GSK3739937 as suspension in Treatment Period 3.
|
Part 1 (Cohort 2) - GSK3739937 SD 30 mg/ GSK3739937 SD 160 mg/SD PBO
Participants received single oral dose of 30 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of 160 mg of GSK3739937 in Period 2, and followed by single oral dose of Placebo in Period 3.
|
Part 2 - Once Daily (QD) PBO
Participants received once daily oral doses of Placebo as suspension for 14 days in Treatment Period 1.
|
Part 2 (Cohort 3) - GSK3739937 QD 25 mg
Participants received once daily oral doses of 25 mg of GSK3739937 as suspension for 14 days in Treatment Period 1.
|
Part 2 (Cohort 4) - GSK3739937 QD 50 mg
Participants received once daily oral doses of 50 mg of GSK3739937 as suspension for 14 days in Treatment Period 1.
|
Part 2 (Cohort 5) - GSK3739937 QD 100 mg
Participants received once daily oral doses of 100 mg of GSK3739937 as suspension for 18 days in Treatment Period 1.
|
Part 2 - Once Weekly (QW) PBO
Participants received once weekly oral doses of Placebo as suspension for over 3 weeks in Treatment Period 1.
|
Part 2 (Cohort 6) - GSK3739937 QW 500 mg
Participants received once weekly oral doses of 500 mg of GSK3739937 as suspension for over 3 weeks in Treatment Period 1.
|
Part 3 (Cohort 7) - GSK3739937 PiB Fed/ GSK3739937 Tablet Fed/ GSK3739937 Tablet Fasted
Participants received single dose of 100 mg of powder in bottle (PiB) as oral suspension under moderate fed conditions in Treatment Period 1, followed by single oral dose of 100 mg of GSK3739937 tablet under moderate fed conditions in Treatment Period 2 and followed by single dose of 100 mg of GSK3739937 tablet under fasted conditions in Treatment Period 3.
|
Part 3 (Cohort 7) - GSK3739937 Tablet Fed/ GSK3739937 Tablet Fasted/ GSK3739937 PiB Fed
Participants received single oral dose of 100 mg of GSK3739937 tablet under moderate fed conditions in Treatment Period 1, followed by single oral dose of 100 mg GSK3739937 tablet under fasted conditions in Treatment Period 2 and followed by single dose of 100 mg PiB as oral suspension under moderate fed conditions in Treatment Period 3.
|
Part 3 (Cohort 7) - GSK3739937 Tablet Fasted/ GSK3739937 PiB Fed/ GSK3739937 Tablet Fed
Participants received single oral dose of 100 mg of GSK3739937 tablet under fasted condition in Treatment Period 1, followed by single oral dose of 100 mg PiB as oral suspension under moderate fed conditions in Treatment Period 2 and followed by single oral dose of 100 mg GSK3739937 tablet under fed conditions in Treatment Period 3.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1:Treatment Period 1-Up to 9 Weeks
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1:Treatment Period 2-Up to 9 Weeks
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1:Treatment Period 2-Up to 9 Weeks
Protocol Deviation
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1:Treatment Period 3-Up to 9 Weeks
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1:Treatment Period 3-Up to 9 Weeks
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2:Treatment Period 1-Up to 5 Weeks
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 3:Treatment Period 1-Up to 4 Weeks
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 3:Treatment Period 2-Up to 4 Weeks
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Part 1 (Cohort 1) - Single Dose (SD) Placebo (PBO)/GSK3739937 SD 80 mg/GSK3739937 SD 320 mg
n=6 Participants
Participants received single oral dose of placebo as suspension in Treatment Period 1, followed by single oral dose of 80 milligrams (mg) of GSK3739937 in Treatment Period 2, and followed by single oral dose of 320 mg of GSK3739937 in Treatment Period 3.
|
Part 1 (Cohort 1) - GSK3739937 SD 10 mg/ SD PBO/ GSK3739937 SD 320 mg
n=3 Participants
Participants received single oral dose of 10 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of placebo as suspension in Treatment Period 2, and followed by single oral dose of 320 mg of GSK3739937 as suspension in Treatment Period 3.
|
Part 1 (Cohort 1) - GSK3739937 SD 10 mg/ GSK3739937 SD 80 mg/SD PBO
n=4 Participants
Participants received single oral dose of 10 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of 80 mg of GSK3739937 as suspension in Treatment Period 2, and followed by single oral dose of placebo as suspension in Treatment Period 3.
|
Part 1 (Cohort 1) - GSK3739937 SD 800 mg
n=6 Participants
Participants received single oral dose of 800 mg of GSK3739937 as suspension in Treatment Period 1.
|
Part 1 (Cohort 1) - SD PBO
n=3 Participants
Participants received single oral dose of Placebo in Treatment Period 1.
|
Part 1 (Cohort 2) - SD PBO/ GSK3739937 SD 160 mg/ GSK3739937 SD 640 mg
n=5 Participants
Participants received single oral dose of Placebo as suspension in Treatment Period 1, followed by single oral dose of 160 mg of GSK3739937 as suspension in Treatment Period 2, and followed by single oral dose of 640 mg of GSK3739937 as suspension Treatment in Period 3.
|
Part 1 (Cohort 2) - GSK3739937 SD 30mg/ SD PBO/ GSK3739937 SD 640mg
n=4 Participants
Participants received single oral dose of 30 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of Placebo as suspension in Treatment Period 2, and followed by single oral dose of 640 mg of GSK3739937 as suspension in Treatment Period 3.
|
Part 1 (Cohort 2) - GSK3739937 SD 30 mg/ GSK3739937 SD 160 mg/SD PBO
n=3 Participants
Participants received single oral dose of 30 mg of GSK3739937 as suspension in Treatment Period 1, followed by single oral dose of 160 mg of GSK3739937 in Period 2, and followed by single oral dose of Placebo in Period 3.
|
Part 2 - Once Daily (QD) PBO
n=9 Participants
Participants received once daily oral doses of Placebo as suspension for 14 days in Treatment Period 1.
|
Part 2 (Cohort 3) - GSK3739937 QD 25 mg
n=7 Participants
Participants received once daily oral doses of 25 mg of GSK3739937 as suspension for 14 days in Treatment Period 1.
|
Part 2 (Cohort 4) - GSK3739937 QD 50 mg
n=7 Participants
Participants received once daily oral doses of 50 mg of GSK3739937 as suspension for 14 days in Treatment Period 1.
|
Part 2 (Cohort 5) - GSK3739937 QD 100 mg
n=7 Participants
Participants received once daily oral doses of 100 mg of GSK3739937 as suspension for 18 days in Treatment Period 1.
|
Part 2 - Once Weekly (QW) PBO
n=3 Participants
Participants received once weekly oral doses of Placebo as suspension for over 3 weeks in Treatment Period 1.
|
Part 2 (Cohort 6) - GSK3739937 QW 500 mg
n=7 Participants
Participants received once weekly oral doses of 500 mg of GSK3739937 as suspension for over 3 weeks in Treatment Period 1.
|
Part 3 (Cohort 7) - GSK3739937 PiB Fed/ GSK3739937 Tablet Fed/ GSK3739937 Tablet Fasted
n=5 Participants
Participants received single dose of 100 mg of powder in bottle (PiB) as oral suspension under moderate fed conditions in Treatment Period 1, followed by single oral dose of 100 mg of GSK3739937 tablet under moderate fed conditions in Treatment Period 2 and followed by single dose of 100 mg of GSK3739937 tablet under fasted conditions in Treatment Period 3.
|
Part 3 (Cohort 7) - GSK3739937 Tablet Fed/ GSK3739937 Tablet Fasted/ GSK3739937 PiB Fed
n=6 Participants
Participants received single oral dose of 100 mg of GSK3739937 tablet under moderate fed conditions in Treatment Period 1, followed by single oral dose of 100 mg GSK3739937 tablet under fasted conditions in Treatment Period 2 and followed by single dose of 100 mg PiB as oral suspension under moderate fed conditions in Treatment Period 3.
|
Part 3 (Cohort 7) - GSK3739937 Tablet Fasted/ GSK3739937 PiB Fed/ GSK3739937 Tablet Fed
n=6 Participants
Participants received single oral dose of 100 mg of GSK3739937 tablet under fasted condition in Treatment Period 1, followed by single oral dose of 100 mg PiB as oral suspension under moderate fed conditions in Treatment Period 2 and followed by single oral dose of 100 mg GSK3739937 tablet under fed conditions in Treatment Period 3.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<=18
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=333 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
19-64
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
5 Participants
n=16 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
7 Participants
n=23 Participants
|
7 Participants
n=3 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=2 Participants
|
5 Participants
n=333 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
91 Participants
n=5 Participants
|
|
Age, Customized
>=65
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=333 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=333 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
5 Participants
n=16 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
7 Participants
n=23 Participants
|
7 Participants
n=3 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=2 Participants
|
5 Participants
n=333 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=5 Participants
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=333 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=333 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
4 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
2 Participants
n=23 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=2 Participants
|
2 Participants
n=333 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=333 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
3 Participants
n=23 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=2 Participants
|
3 Participants
n=333 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 27 weeksPopulation: Safety Population included all randomized participants who received at least one dose of study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/Standard of care (SOC) to prevent one of the other outcomes mentioned before.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=21 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Number of Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
1 Events
|
3 Events
|
7 Events
|
3 Events
|
0 Events
|
2 Events
|
4 Events
|
2 Events
|
|
Part 1 - Number of Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
PRIMARY outcome
Timeframe: Up to 5 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=7 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=3 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=7 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 - Number of Any AEs and SAEs
AEs
|
0 Events
|
2 Events
|
3 Events
|
5 Events
|
0 Events
|
4 Events
|
—
|
—
|
|
Part 2 - Number of Any AEs and SAEs
SAEs
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 16 weeksPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the participant or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Number of Any AEs and SAEs
AEs
|
4 Events
|
6 Events
|
2 Events
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Number of Any AEs and SAEs
SAEs
|
0 Events
|
0 Events
|
0 Events
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes
|
-0.1 Giga cells per liter (10^9 cells/L)
|
0 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.063
|
0.04 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.124
|
-0.02 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.194
|
-0.03 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.121
|
0.02 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.133
|
0 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.11
|
-0.08 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.117
|
|
Part 1 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils
|
0.7 Giga cells per liter (10^9 cells/L)
|
0.22 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.306
|
0.3 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.486
|
0.08 Giga cells per liter (10^9 cells/L)
Standard Deviation 1.303
|
0.03 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.468
|
0.33 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.48
|
0.22 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.117
|
-0.03 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.7
|
|
Part 1 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets
|
2 Giga cells per liter (10^9 cells/L)
|
8.2 Giga cells per liter (10^9 cells/L)
Standard Deviation 25.59
|
0.3 Giga cells per liter (10^9 cells/L)
Standard Deviation 26.73
|
16 Giga cells per liter (10^9 cells/L)
Standard Deviation 27.71
|
-6.3 Giga cells per liter (10^9 cells/L)
Standard Deviation 7.87
|
8.8 Giga cells per liter (10^9 cells/L)
Standard Deviation 20.5
|
13.2 Giga cells per liter (10^9 cells/L)
Standard Deviation 19.05
|
0.2 Giga cells per liter (10^9 cells/L)
Standard Deviation 13
|
|
Part 1 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils
|
0 Giga cells per liter (10^9 cells/L)
|
0 Giga cells per liter (10^9 cells/L)
Standard Deviation 0
|
-0.01 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.024
|
0 Giga cells per liter (10^9 cells/L)
Standard Deviation 0
|
-0.02 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.041
|
0 Giga cells per liter (10^9 cells/L)
Standard Deviation 0
|
0 Giga cells per liter (10^9 cells/L)
Standard Deviation 0
|
0 Giga cells per liter (10^9 cells/L)
Standard Deviation 0
|
|
Part 1 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils
|
-0.2 Giga cells per liter (10^9 cells/L)
|
0.02 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.147
|
-0.05 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.092
|
-0.08 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.075
|
-0.02 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.075
|
-0.02 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.041
|
0.08 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.223
|
-0.07 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.082
|
|
Part 1 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes
|
-0.5 Giga cells per liter (10^9 cells/L)
|
0 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.482
|
0.14 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.391
|
-0.02 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.248
|
-0.13 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.463
|
0.23 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.339
|
0.25 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.084
|
-0.22 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.248
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=3 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils
|
0 10^9 cells/L
Standard Deviation 0
|
0.03 10^9 cells/L
Standard Deviation 0.049
|
0 10^9 cells/L
Standard Deviation 0
|
-0.02 10^9 cells/L
Standard Deviation 0.041
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils
|
-0.03 10^9 cells/L
Standard Deviation 0.095
|
-0.01 10^9 cells/L
Standard Deviation 0.090
|
0.03 10^9 cells/L
Standard Deviation 0.05
|
0.02 10^9 cells/L
Standard Deviation 0.075
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes
|
-0.07 10^9 cells/L
Standard Deviation 0.281
|
0.03 10^9 cells/L
Standard Deviation 0.427
|
-0.13 10^9 cells/L
Standard Deviation 0.26
|
0.15 10^9 cells/L
Standard Deviation 0.274
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes
|
0.04 10^9 cells/L
Standard Deviation 0.113
|
0.01 10^9 cells/L
Standard Deviation 0.135
|
0.02 10^9 cells/L
Standard Deviation 0.139
|
-0.02 10^9 cells/L
Standard Deviation 0.117
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils
|
-0.19 10^9 cells/L
Standard Deviation 0.682
|
0.03 10^9 cells/L
Standard Deviation 0.496
|
-0.47 10^9 cells/L
Standard Deviation 0.784
|
-0.18 10^9 cells/L
Standard Deviation 0.877
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets
|
-3.4 10^9 cells/L
Standard Deviation 18.12
|
-9.7 10^9 cells/L
Standard Deviation 20.11
|
-11.9 10^9 cells/L
Standard Deviation 16.24
|
-15.5 10^9 cells/L
Standard Deviation 32.93
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils
|
0 10^9 cells/L
Standard Deviation 0
|
—
|
0 10^9 cells/L
Standard Deviation 0
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils
|
-0.01 10^9 cells/L
Standard Deviation 0.069
|
—
|
0.03 10^9 cells/L
Standard Deviation 0.115
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes
|
0.04 10^9 cells/L
Standard Deviation 0.378
|
—
|
0.23 10^9 cells/L
Standard Deviation 0.115
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes
|
0.06 10^9 cells/L
Standard Deviation 0.079
|
—
|
0.07 10^9 cells/L
Standard Deviation 0.058
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils
|
-0.27 10^9 cells/L
Standard Deviation 0.315
|
—
|
-0.10 10^9 cells/L
Standard Deviation 0.173
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets
|
-9.3 10^9 cells/L
Standard Deviation 30.8
|
—
|
-21.3 10^9 cells/L
Standard Deviation 47.72
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Basophils
|
0 10^9 cells/L
Standard Deviation 0
|
0 10^9 cells/L
Standard Deviation 0
|
0.01 10^9 cells/L
Standard Deviation 0.026
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Eosinophils
|
-0.05 10^9 cells/L
Standard Deviation 0.087
|
-0.05 10^9 cells/L
Standard Deviation 0.092
|
-0.05 10^9 cells/L
Standard Deviation 0.052
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Lymphocytes
|
-0.08 10^9 cells/L
Standard Deviation 0.407
|
0.16 10^9 cells/L
Standard Deviation 0.184
|
0.11 10^9 cells/L
Standard Deviation 0.253
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Monocytes
|
-0.01 10^9 cells/L
Standard Deviation 0.132
|
0.04 10^9 cells/L
Standard Deviation 0.083
|
0.01 10^9 cells/L
Standard Deviation 0.099
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Neutrophils
|
-0.15 10^9 cells/L
Standard Deviation 1.253
|
0.17 10^9 cells/L
Standard Deviation 0.594
|
0.16 10^9 cells/L
Standard Deviation 0.703
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Hematology Parameters - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets
Platelets
|
1.5 10^9 cells/L
Standard Deviation 22.48
|
-6.7 10^9 cells/L
Standard Deviation 21.4
|
7 10^9 cells/L
Standard Deviation 15.83
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Hematology Parameters - Erythrocytes Count
|
0.17 Trillion cells per liter (10^12 cells/L)
|
0.197 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.3088
|
0.079 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.1441
|
0.245 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.1623
|
0.048 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.2548
|
0.11 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.1368
|
0.157 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.1833
|
0.182 Trillion cells per liter (10^12 cells/L)
Standard Deviation 0.1526
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameters - Erythrocytes Count
|
0.017 10^12 cells/L
Standard Deviation 0.175
|
-0.227 10^12 cells/L
Standard Deviation 0.2423
|
-0.06 10^12 cells/L
Standard Deviation 0.1592
|
0.037 10^12 cells/L
Standard Deviation 0.2601
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameters - Erythrocytes Count
|
-0.014 10^12 cells/L
Standard Deviation 0.1021
|
—
|
-0.060 10^12 cells/L
Standard Deviation 0.2787
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Erythrocytes count. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Hematology Parameters - Erythrocytes Count
|
0.197 10^12 cells/L
Standard Deviation 0.2287
|
0.189 10^12 cells/L
Standard Deviation 0.2014
|
0.229 10^12 cells/L
Standard Deviation 0.2193
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
|
-0.5 Picogram (pg)
|
0.33 Picogram (pg)
Standard Deviation 0.294
|
0.09 Picogram (pg)
Standard Deviation 0.314
|
-0.08 Picogram (pg)
Standard Deviation 0.387
|
-0.13 Picogram (pg)
Standard Deviation 0.32
|
-0.13 Picogram (pg)
Standard Deviation 0.528
|
-0.02 Picogram (pg)
Standard Deviation 0.232
|
-0.03 Picogram (pg)
Standard Deviation 0.103
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
|
-0.3 Picogram (pg)
Standard Deviation 0.44
|
0.16 Picogram (pg)
Standard Deviation 0.172
|
0.02 Picogram (pg)
Standard Deviation 0.63
|
-0.08 Picogram (pg)
Standard Deviation 0.605
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Mean Corpuscular Hemoglobin (MCH). Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
|
-0.83 Picogram (pg)
Standard Deviation 0.399
|
—
|
-0.87 Picogram (pg)
Standard Deviation 0.666
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Mean Corpuscular Hemoglobin (MCH). Blood samples were collected to assess change from baseline in Erythrocytes Mean Corpuscular Hemoglobin (MCH). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Hematology Parameter - Erythrocytes Mean Corpuscular Hemoglobin (MCH)
|
-0.24 Picogram (pg)
Standard Deviation 0.487
|
0.05 Picogram (pg)
Standard Deviation 0.54
|
0 Picogram (pg)
Standard Deviation 0.433
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Hematology Parameter - Hematocrit
|
0.014 Proportion of red blood cells in blood
|
0.015 Proportion of red blood cells in blood
Standard Deviation 0.0304
|
0.0083 Proportion of red blood cells in blood
Standard Deviation 0.01231
|
0.0237 Proportion of red blood cells in blood
Standard Deviation 0.01491
|
0.0012 Proportion of red blood cells in blood
Standard Deviation 0.02409
|
0.0047 Proportion of red blood cells in blood
Standard Deviation 0.00866
|
0.0117 Proportion of red blood cells in blood
Standard Deviation 0.01862
|
0.0175 Proportion of red blood cells in blood
Standard Deviation 0.01319
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Hematocrit
|
0.0066 Proportion of red blood cells in blood
Standard Deviation 0.01838
|
-0.0217 Proportion of red blood cells in blood
Standard Deviation 0.01963
|
-0.0081 Proportion of red blood cells in blood
Standard Deviation 0.01342
|
0.0043 Proportion of red blood cells in blood
Standard Deviation 0.01929
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Hematocrit
|
-0.0094 Proportion of red blood cells in blood
Standard Deviation 0.00781
|
—
|
-0.0120 Proportion of red blood cells in blood
Standard Deviation 0.02685
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Hematocrit. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Hematology Parameter - Hematocrit
|
0.013 Proportion of red blood cells in blood
Standard Deviation 0.02076
|
0.0159 Proportion of red blood cells in blood
Standard Deviation 0.01793
|
0.0182 Proportion of red blood cells in blood
Standard Deviation 0.01826
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Hematology Parameter - Reticulocytes
|
0.002 Proportion of reticulocytes in blood
|
-0.0045 Proportion of reticulocytes in blood
Standard Deviation 0.00622
|
0.0008 Proportion of reticulocytes in blood
Standard Deviation 0.00363
|
-0.0008 Proportion of reticulocytes in blood
Standard Deviation 0.00264
|
-0.0007 Proportion of reticulocytes in blood
Standard Deviation 0.00234
|
-0.0015 Proportion of reticulocytes in blood
Standard Deviation 0.00302
|
-0.0008 Proportion of reticulocytes in blood
Standard Deviation 0.00194
|
-0.0008 Proportion of reticulocytes in blood
Standard Deviation 0.0016
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Reticulocytes
|
-0.0011 Proportion of reticulocytes in blood
Standard Deviation 0.00219
|
0.0010 Proportion of reticulocytes in blood
Standard Deviation 0.00306
|
-0.0017 Proportion of reticulocytes in blood
Standard Deviation 0.0024
|
-0.0012 Proportion of reticulocytes in blood
Standard Deviation 0.00264
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Reticulocytes
|
-0.0001 Proportion of reticulocytes in blood
Standard Deviation 0.00227
|
—
|
0.0003 Proportion of reticulocytes in blood
Standard Deviation 0.00379
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Reticulocytes. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Hematology Parameter - Reticulocytes
|
-0.0009 Proportion of reticulocytes in blood
Standard Deviation 0.00255
|
-0.0012 Proportion of reticulocytes in blood
Standard Deviation 0.00224
|
-0.0011 Proportion of reticulocytes in blood
Standard Deviation 0.00231
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
|
2 Grams per liter (g/L)
|
7.5 Grams per liter (g/L)
Standard Deviation 8.41
|
2.8 Grams per liter (g/L)
Standard Deviation 4.44
|
6.7 Grams per liter (g/L)
Standard Deviation 5.2
|
1 Grams per liter (g/L)
Standard Deviation 8.51
|
2.7 Grams per liter (g/L)
Standard Deviation 2.73
|
4.3 Grams per liter (g/L)
Standard Deviation 5.68
|
5.2 Grams per liter (g/L)
Standard Deviation 4.07
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
|
-1 Grams per liter (g/L)
Standard Deviation 7.21
|
-5.7 Grams per liter (g/L)
Standard Deviation 6.70
|
-1.6 Grams per liter (g/L)
Standard Deviation 5.13
|
0.5 Grams per liter (g/L)
Standard Deviation 7.74
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
|
-4.3 Grams per liter (g/L)
Standard Deviation 2.63
|
—
|
-5.7 Grams per liter (g/L)
Standard Deviation 7.64
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Hemoglobin (Hb). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Hematology Parameter - Hemoglobin (Hb)
|
4.5 Grams per liter (g/L)
Standard Deviation 7.07
|
5.7 Grams per liter (g/L)
Standard Deviation 5.37
|
6.7 Grams per liter (g/L)
Standard Deviation 5.87
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK)
ALP
|
5 International units per Liter (IU/L)
|
8.3 International units per Liter (IU/L)
Standard Deviation 4.27
|
4.6 International units per Liter (IU/L)
Standard Deviation 6.06
|
6.7 International units per Liter (IU/L)
Standard Deviation 3.72
|
3 International units per Liter (IU/L)
Standard Deviation 3.95
|
6.2 International units per Liter (IU/L)
Standard Deviation 4.92
|
8.8 International units per Liter (IU/L)
Standard Deviation 8.04
|
6.2 International units per Liter (IU/L)
Standard Deviation 2.14
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK)
AST
|
-8 International units per Liter (IU/L)
|
-4.5 International units per Liter (IU/L)
Standard Deviation 4.93
|
-1.5 International units per Liter (IU/L)
Standard Deviation 6.07
|
-2 International units per Liter (IU/L)
Standard Deviation 2.83
|
-0.5 International units per Liter (IU/L)
Standard Deviation 4.04
|
-3.8 International units per Liter (IU/L)
Standard Deviation 4.26
|
-1.8 International units per Liter (IU/L)
Standard Deviation 4.79
|
-1.5 International units per Liter (IU/L)
Standard Deviation 3.02
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK)
ALT
|
-1 International units per Liter (IU/L)
|
-4.2 International units per Liter (IU/L)
Standard Deviation 6.05
|
1.6 International units per Liter (IU/L)
Standard Deviation 7.78
|
-0.8 International units per Liter (IU/L)
Standard Deviation 3.49
|
0.3 International units per Liter (IU/L)
Standard Deviation 9.35
|
-3.5 International units per Liter (IU/L)
Standard Deviation 6.32
|
1.2 International units per Liter (IU/L)
Standard Deviation 10.19
|
-1.3 International units per Liter (IU/L)
Standard Deviation 3.39
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK)
CPK
|
0.776 International units per Liter (IU/L)
|
-0.1978 International units per Liter (IU/L)
Standard Deviation 0.48809
|
-29.3 International units per Liter (IU/L)
Standard Deviation 140.65
|
-0.0777 International units per Liter (IU/L)
Standard Deviation 0.72185
|
-0.1292 International units per Liter (IU/L)
Standard Deviation 0.91507
|
0.2242 International units per Liter (IU/L)
Standard Deviation 0.3425
|
-60.5 International units per Liter (IU/L)
Standard Deviation 132.53
|
-20 International units per Liter (IU/L)
Standard Deviation 39.47
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and Serum CPK
ALP
|
-4.6 International units per Liter (IU/L)
Standard Deviation 10.61
|
5.9 International units per Liter (IU/L)
Standard Deviation 5.34
|
-0.4 International units per Liter (IU/L)
Standard Deviation 14.44
|
3.0 International units per Liter (IU/L)
Standard Deviation 9.76
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and Serum CPK
ALT
|
-5.9 International units per Liter (IU/L)
Standard Deviation 5.84
|
-3.9 International units per Liter (IU/L)
Standard Deviation 7.10
|
-3.1 International units per Liter (IU/L)
Standard Deviation 6.9
|
0.3 International units per Liter (IU/L)
Standard Deviation 4.27
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and Serum CPK
AST
|
-7.1 International units per Liter (IU/L)
Standard Deviation 5.52
|
-4.1 International units per Liter (IU/L)
Standard Deviation 4.53
|
-4.6 International units per Liter (IU/L)
Standard Deviation 5.2
|
3.2 International units per Liter (IU/L)
Standard Deviation 3.25
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and Serum CPK
CPK
|
—
|
19.4 International units per Liter (IU/L)
Standard Deviation 88.50
|
-1 International units per Liter (IU/L)
Standard Deviation 26.43
|
14.8 International units per Liter (IU/L)
Standard Deviation 41.63
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter -ALT, AST, ALP and Serum CPK
ALP
|
1.9 International units per Liter (IU/L)
Standard Deviation 4.02
|
—
|
0.0 International units per Liter (IU/L)
Standard Deviation 2.65
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter -ALT, AST, ALP and Serum CPK
ALT
|
-3.1 International units per Liter (IU/L)
Standard Deviation 2.91
|
—
|
-2.3 International units per Liter (IU/L)
Standard Deviation 7.77
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter -ALT, AST, ALP and Serum CPK
AST
|
-3 International units per Liter (IU/L)
Standard Deviation 1.83
|
—
|
-3.0 International units per Liter (IU/L)
Standard Deviation 2.65
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter -ALT, AST, ALP and Serum CPK
CPK
|
-22.6 International units per Liter (IU/L)
Standard Deviation 35.72
|
—
|
-18.7 International units per Liter (IU/L)
Standard Deviation 14.84
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP) and Serum Creatine Phosphokinase (CPK). Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and CPK
CPK
|
-22.2 International units per Liter (IU/L)
Standard Deviation 45.6
|
-62.1 International units per Liter (IU/L)
Standard Deviation 73.59
|
-27.3 International units per Liter (IU/L)
Standard Deviation 52.49
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and CPK
ALP
|
5.4 International units per Liter (IU/L)
Standard Deviation 5.91
|
5.2 International units per Liter (IU/L)
Standard Deviation 4.78
|
5.9 International units per Liter (IU/L)
Standard Deviation 6.42
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and CPK
ALT
|
-0.2 International units per Liter (IU/L)
Standard Deviation 4.92
|
-0.4 International units per Liter (IU/L)
Standard Deviation 3.16
|
1.3 International units per Liter (IU/L)
Standard Deviation 4.32
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameter - ALT, AST, ALP and CPK
AST
|
0.4 International units per Liter (IU/L)
Standard Deviation 4.4
|
-0.9 International units per Liter (IU/L)
Standard Deviation 3.02
|
0.3 International units per Liter (IU/L)
Standard Deviation 3.67
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Calcium
|
-0.025 Millimoles per Liter (mmol/L)
|
0.0208 Millimoles per Liter (mmol/L)
Standard Deviation 0.10249
|
0.0693 Millimoles per Liter (mmol/L)
Standard Deviation 0.10417
|
0.1453 Millimoles per Liter (mmol/L)
Standard Deviation 0.04816
|
0.0707 Millimoles per Liter (mmol/L)
Standard Deviation 0.13915
|
0.0208 Millimoles per Liter (mmol/L)
Standard Deviation 0.10888
|
0.2203 Millimoles per Liter (mmol/L)
Standard Deviation 0.17728
|
0.0375 Millimoles per Liter (mmol/L)
Standard Deviation 0.05646
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Cholesterol
|
0.104 Millimoles per Liter (mmol/L)
|
-0.2627 Millimoles per Liter (mmol/L)
Standard Deviation 0.52795
|
0.1294 Millimoles per Liter (mmol/L)
Standard Deviation 0.59228
|
0.444 Millimoles per Liter (mmol/L)
Standard Deviation 0.16643
|
-0.224 Millimoles per Liter (mmol/L)
Standard Deviation 0.87169
|
0.0047 Millimoles per Liter (mmol/L)
Standard Deviation 0.5061
|
0.1898 Millimoles per Liter (mmol/L)
Standard Deviation 0.3552
|
0.142 Millimoles per Liter (mmol/L)
Standard Deviation 0.09784
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
HDL
|
0.181 Millimoles per Liter (mmol/L)
|
-0.069 Millimoles per Liter (mmol/L)
Standard Deviation 0.20186
|
-0.0187 Millimoles per Liter (mmol/L)
Standard Deviation 0.20182
|
0.1247 Millimoles per Liter (mmol/L)
Standard Deviation 0.15293
|
-0.086 Millimoles per Liter (mmol/L)
Standard Deviation 0.13432
|
0.082 Millimoles per Liter (mmol/L)
Standard Deviation 0.11534
|
-0.0388 Millimoles per Liter (mmol/L)
Standard Deviation 0.30208
|
-0.043 Millimoles per Liter (mmol/L)
Standard Deviation 0.07956
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Glucose
|
-0.499 Millimoles per Liter (mmol/L)
|
-0.3147 Millimoles per Liter (mmol/L)
Standard Deviation 0.22689
|
-0.29 Millimoles per Liter (mmol/L)
Standard Deviation 0.46027
|
-0.1387 Millimoles per Liter (mmol/L)
Standard Deviation 0.36972
|
-0.157 Millimoles per Liter (mmol/L)
Standard Deviation 0.22077
|
-0.379 Millimoles per Liter (mmol/L)
Standard Deviation 0.22041
|
-0.1848 Millimoles per Liter (mmol/L)
Standard Deviation 0.25449
|
-0.3147 Millimoles per Liter (mmol/L)
Standard Deviation 0.25488
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Bicarbonate
|
2 Millimoles per Liter (mmol/L)
|
1.8 Millimoles per Liter (mmol/L)
Standard Deviation 2.48
|
1.8 Millimoles per Liter (mmol/L)
Standard Deviation 2.62
|
3.3 Millimoles per Liter (mmol/L)
Standard Deviation 3.5
|
1.7 Millimoles per Liter (mmol/L)
Standard Deviation 1.97
|
-0.2 Millimoles per Liter (mmol/L)
Standard Deviation 2.14
|
0.7 Millimoles per Liter (mmol/L)
Standard Deviation 2.25
|
1.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.51
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Chloride
|
-1 Millimoles per Liter (mmol/L)
|
-0.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.75
|
-1.6 Millimoles per Liter (mmol/L)
Standard Deviation 2.79
|
-5 Millimoles per Liter (mmol/L)
Standard Deviation 1.41
|
1.7 Millimoles per Liter (mmol/L)
Standard Deviation 1.51
|
-1.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.51
|
-0.8 Millimoles per Liter (mmol/L)
Standard Deviation 1.83
|
0.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.03
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Potassium
|
-0.2 Millimoles per Liter (mmol/L)
|
0.18 Millimoles per Liter (mmol/L)
Standard Deviation 0.354
|
-0.02 Millimoles per Liter (mmol/L)
Standard Deviation 0.303
|
0.18 Millimoles per Liter (mmol/L)
Standard Deviation 0.293
|
0.1 Millimoles per Liter (mmol/L)
Standard Deviation 0.261
|
-0.28 Millimoles per Liter (mmol/L)
Standard Deviation 0.24
|
-0.07 Millimoles per Liter (mmol/L)
Standard Deviation 0.234
|
-0.12 Millimoles per Liter (mmol/L)
Standard Deviation 0.214
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
LDL
|
-0.078 Millimoles per Liter (mmol/L)
|
-0.0605 Millimoles per Liter (mmol/L)
Standard Deviation 0.51701
|
-0.0027 Millimoles per Liter (mmol/L)
Standard Deviation 0.44009
|
0.5217 Millimoles per Liter (mmol/L)
Standard Deviation 0.21608
|
-0.5298 Millimoles per Liter (mmol/L)
Standard Deviation 0.52526
|
0.004 Millimoles per Liter (mmol/L)
Standard Deviation 0.35306
|
0.2023 Millimoles per Liter (mmol/L)
Standard Deviation 0.22274
|
-0.0388 Millimoles per Liter (mmol/L)
Standard Deviation 0.29351
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Magnesium
|
0 Millimoles per Liter (mmol/L)
|
-0.0137 Millimoles per Liter (mmol/L)
Standard Deviation 0.06173
|
0.0046 Millimoles per Liter (mmol/L)
Standard Deviation 0.05426
|
0.0068 Millimoles per Liter (mmol/L)
Standard Deviation 0.03086
|
-0.0478 Millimoles per Liter (mmol/L)
Standard Deviation 0.03086
|
0.0752 Millimoles per Liter (mmol/L)
Standard Deviation 0.06035
|
0.0342 Millimoles per Liter (mmol/L)
Standard Deviation 0.03086
|
0.0137 Millimoles per Liter (mmol/L)
Standard Deviation 0.02117
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Phosphate
|
0.097 Millimoles per Liter (mmol/L)
|
0.0377 Millimoles per Liter (mmol/L)
Standard Deviation 0.1266
|
0.0611 Millimoles per Liter (mmol/L)
Standard Deviation 0.13184
|
0.124 Millimoles per Liter (mmol/L)
Standard Deviation 0.13169
|
-0.0108 Millimoles per Liter (mmol/L)
Standard Deviation 0.16164
|
0.0052 Millimoles per Liter (mmol/L)
Standard Deviation 0.08782
|
0.043 Millimoles per Liter (mmol/L)
Standard Deviation 0.12387
|
-0.0108 Millimoles per Liter (mmol/L)
Standard Deviation 0.05669
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Sodium
|
0 Millimoles per Liter (mmol/L)
|
1 Millimoles per Liter (mmol/L)
Standard Deviation 1.26
|
0 Millimoles per Liter (mmol/L)
Standard Deviation 1.64
|
0.2 Millimoles per Liter (mmol/L)
Standard Deviation 0.98
|
1 Millimoles per Liter (mmol/L)
Standard Deviation 1.26
|
-0.7 Millimoles per Liter (mmol/L)
Standard Deviation 1.51
|
-0.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.37
|
2.2 Millimoles per Liter (mmol/L)
Standard Deviation 0.98
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
Triglycerides
|
0.18 Millimoles per Liter (mmol/L)
|
-0.2225 Millimoles per Liter (mmol/L)
Standard Deviation 0.43845
|
0.1683 Millimoles per Liter (mmol/L)
Standard Deviation 0.46481
|
0.0318 Millimoles per Liter (mmol/L)
Standard Deviation 0.41469
|
-0.2337 Millimoles per Liter (mmol/L)
Standard Deviation 0.3573
|
-0.0863 Millimoles per Liter (mmol/L)
Standard Deviation 0.32709
|
0.087 Millimoles per Liter (mmol/L)
Standard Deviation 0.12521
|
0.1467 Millimoles per Liter (mmol/L)
Standard Deviation 0.25766
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen, Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, Triglycerides
BUN
|
1.071 Millimoles per Liter (mmol/L)
|
-0.4165 Millimoles per Liter (mmol/L)
Standard Deviation 0.79561
|
-0.2777 Millimoles per Liter (mmol/L)
Standard Deviation 0.7798
|
0.2975 Millimoles per Liter (mmol/L)
Standard Deviation 0.7629
|
-0.119 Millimoles per Liter (mmol/L)
Standard Deviation 0.62517
|
0.2975 Millimoles per Liter (mmol/L)
Standard Deviation 0.47451
|
-0.2975 Millimoles per Liter (mmol/L)
Standard Deviation 0.72872
|
-0.595 Millimoles per Liter (mmol/L)
Standard Deviation 0.29149
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Sodium
|
1.3 Millimoles per Liter (mmol/L)
Standard Deviation 0.76
|
-0.9 Millimoles per Liter (mmol/L)
Standard Deviation 1.07
|
0.6 Millimoles per Liter (mmol/L)
Standard Deviation 1.67
|
0.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.97
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Triglycerides
|
-0.1614 Millimoles per Liter (mmol/L)
Standard Deviation 0.26907
|
0.0434 Millimoles per Liter (mmol/L)
Standard Deviation 0.20744
|
0.0403 Millimoles per Liter (mmol/L)
Standard Deviation 0.20877
|
0.2577 Millimoles per Liter (mmol/L)
Standard Deviation 0.33429
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
BUN
|
0.408 Millimoles per Liter (mmol/L)
Standard Deviation 0.90851
|
-0.1020 Millimoles per Liter (mmol/L)
Standard Deviation 1.02466
|
0.0397 Millimoles per Liter (mmol/L)
Standard Deviation 0.9849
|
0.1190 Millimoles per Liter (mmol/L)
Standard Deviation 0.53748
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
LDL
|
-0.5244 Millimoles per Liter (mmol/L)
Standard Deviation 0.48959
|
-0.2807 Millimoles per Liter (mmol/L)
Standard Deviation 0.30973
|
-0.2902 Millimoles per Liter (mmol/L)
Standard Deviation 0.38135
|
-0.0903 Millimoles per Liter (mmol/L)
Standard Deviation 0.86478
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Magnesium
|
-0.0996 Millimoles per Liter (mmol/L)
Standard Deviation 0.06635
|
-0.0527 Millimoles per Liter (mmol/L)
Standard Deviation 0.05659
|
-0.0547 Millimoles per Liter (mmol/L)
Standard Deviation 0.09168
|
-0.0205 Millimoles per Liter (mmol/L)
Standard Deviation 0.06737
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Phosphate
|
-0.1477 Millimoles per Liter (mmol/L)
Standard Deviation 0.10973
|
0.0831 Millimoles per Liter (mmol/L)
Standard Deviation 0.11469
|
-0.0573 Millimoles per Liter (mmol/L)
Standard Deviation 0.12367
|
0.0485 Millimoles per Liter (mmol/L)
Standard Deviation 0.09964
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Chloride
|
3 Millimoles per Liter (mmol/L)
Standard Deviation 1.15
|
-1.0 Millimoles per Liter (mmol/L)
Standard Deviation 1.63
|
0.3 Millimoles per Liter (mmol/L)
Standard Deviation 2.5
|
-1.3 Millimoles per Liter (mmol/L)
Standard Deviation 2.16
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Calcium
|
-0.2136 Millimoles per Liter (mmol/L)
Standard Deviation 0.12771
|
-0.0286 Millimoles per Liter (mmol/L)
Standard Deviation 0.08469
|
-0.0306 Millimoles per Liter (mmol/L)
Standard Deviation 0.14997
|
0.0373 Millimoles per Liter (mmol/L)
Standard Deviation 0.07016
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Glucose
|
-0.6027 Millimoles per Liter (mmol/L)
Standard Deviation 0.19341
|
0.0319 Millimoles per Liter (mmol/L)
Standard Deviation 0.35520
|
-0.2773 Millimoles per Liter (mmol/L)
Standard Deviation 0.58989
|
-0.3978 Millimoles per Liter (mmol/L)
Standard Deviation 0.24715
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Bicarbonate
|
-1.4 Millimoles per Liter (mmol/L)
Standard Deviation 1.4
|
-0.6 Millimoles per Liter (mmol/L)
Standard Deviation 2.44
|
-1 Millimoles per Liter (mmol/L)
Standard Deviation 1.94
|
-0.3 Millimoles per Liter (mmol/L)
Standard Deviation 2.07
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Cholesterol
|
-0.6503 Millimoles per Liter (mmol/L)
Standard Deviation 0.68612
|
-0.2843 Millimoles per Liter (mmol/L)
Standard Deviation 0.42535
|
-0.2701 Millimoles per Liter (mmol/L)
Standard Deviation 0.56002
|
0.3708 Millimoles per Liter (mmol/L)
Standard Deviation 0.43447
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
HDL
|
-0.1849 Millimoles per Liter (mmol/L)
Standard Deviation 0.13459
|
-0.0777 Millimoles per Liter (mmol/L)
Standard Deviation 0.14711
|
-0.1438 Millimoles per Liter (mmol/L)
Standard Deviation 0.15951
|
-0.0948 Millimoles per Liter (mmol/L)
Standard Deviation 0.21847
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Potassium
|
-0.29 Millimoles per Liter (mmol/L)
Standard Deviation 0.261
|
0 Millimoles per Liter (mmol/L)
Standard Deviation 0.191
|
-0.09 Millimoles per Liter (mmol/L)
Standard Deviation 0.44
|
-0.22 Millimoles per Liter (mmol/L)
Standard Deviation 0.449
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Calcium
|
-0.0391 Millimoles per Liter (mmol/L)
Standard Deviation 0.10029
|
—
|
-0.0913 Millimoles per Liter (mmol/L)
Standard Deviation 0.14160
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Cholesterol
|
-0.203 Millimoles per Liter (mmol/L)
Standard Deviation 0.56917
|
—
|
-0.4483 Millimoles per Liter (mmol/L)
Standard Deviation 0.39167
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Potassium
|
-0.21 Millimoles per Liter (mmol/L)
Standard Deviation 0.418
|
—
|
-0.10 Millimoles per Liter (mmol/L)
Standard Deviation 0.346
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Phosphate
|
0.0464 Millimoles per Liter (mmol/L)
Standard Deviation 0.08088
|
—
|
0.0540 Millimoles per Liter (mmol/L)
Standard Deviation 0.10437
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
BUN
|
0.408 Millimoles per Liter (mmol/L)
Standard Deviation 0.32121
|
—
|
0.1190 Millimoles per Liter (mmol/L)
Standard Deviation 0.54533
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Glucose
|
-0.3014 Millimoles per Liter (mmol/L)
Standard Deviation 0.14978
|
—
|
-0.2590 Millimoles per Liter (mmol/L)
Standard Deviation 0.23106
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Bicarbonate
|
-0.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.38
|
—
|
-0.7 Millimoles per Liter (mmol/L)
Standard Deviation 2.08
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Chloride
|
0.4 Millimoles per Liter (mmol/L)
Standard Deviation 1.62
|
—
|
1.3 Millimoles per Liter (mmol/L)
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
HDL
|
-0.0703 Millimoles per Liter (mmol/L)
Standard Deviation 0.14776
|
—
|
-0.1037 Millimoles per Liter (mmol/L)
Standard Deviation 0.11860
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
LDL
|
-0.1107 Millimoles per Liter (mmol/L)
Standard Deviation 0.36147
|
—
|
-0.4137 Millimoles per Liter (mmol/L)
Standard Deviation 0.34187
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Magnesium
|
0.0059 Millimoles per Liter (mmol/L)
Standard Deviation 0.04981
|
—
|
0.0137 Millimoles per Liter (mmol/L)
Standard Deviation 0.02367
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Sodium
|
-0.7 Millimoles per Liter (mmol/L)
Standard Deviation 1.5
|
—
|
-0.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.15
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides
Triglycerides
|
0.0129 Millimoles per Liter (mmol/L)
Standard Deviation 0.25175
|
—
|
0.0267 Millimoles per Liter (mmol/L)
Standard Deviation 0.07243
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, Blood Urea Nitrogen (BUN), Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Triglycerides. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Glucose
|
-0.3755 Millimoles per Liter (mmol/L)
Standard Deviation 0.24961
|
-0.2145 Millimoles per Liter (mmol/L)
Standard Deviation 0.27017
|
-0.2033 Millimoles per Liter (mmol/L)
Standard Deviation 0.39
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Bicarbonate
|
0.4 Millimoles per Liter (mmol/L)
Standard Deviation 2.12
|
1.5 Millimoles per Liter (mmol/L)
Standard Deviation 1.64
|
1.5 Millimoles per Liter (mmol/L)
Standard Deviation 1.96
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Calcium
|
0.0793 Millimoles per Liter (mmol/L)
Standard Deviation 0.10607
|
0.0666 Millimoles per Liter (mmol/L)
Standard Deviation 0.07293
|
0.055 Millimoles per Liter (mmol/L)
Standard Deviation 0.10971
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Cholesterol
|
0.1218 Millimoles per Liter (mmol/L)
Standard Deviation 0.3317
|
0.0569 Millimoles per Liter (mmol/L)
Standard Deviation 0.47643
|
0.1087 Millimoles per Liter (mmol/L)
Standard Deviation 0.30739
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Chloride
|
-2.2 Millimoles per Liter (mmol/L)
Standard Deviation 2.14
|
-1.6 Millimoles per Liter (mmol/L)
Standard Deviation 1.92
|
-1.2 Millimoles per Liter (mmol/L)
Standard Deviation 2.57
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
HDL
|
-0.0549 Millimoles per Liter (mmol/L)
Standard Deviation 0.12044
|
-0.0415 Millimoles per Liter (mmol/L)
Standard Deviation 0.1084
|
-0.0259 Millimoles per Liter (mmol/L)
Standard Deviation 0.13992
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Potassium
|
-0.04 Millimoles per Liter (mmol/L)
Standard Deviation 0.361
|
-0.17 Millimoles per Liter (mmol/L)
Standard Deviation 0.364
|
-0.03 Millimoles per Liter (mmol/L)
Standard Deviation 0.422
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
LDL
|
0.2312 Millimoles per Liter (mmol/L)
Standard Deviation 0.46471
|
0.0484 Millimoles per Liter (mmol/L)
Standard Deviation 0.55487
|
0.219 Millimoles per Liter (mmol/L)
Standard Deviation 0.42617
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Magnesium
|
0.0217 Millimoles per Liter (mmol/L)
Standard Deviation 0.06338
|
0.0109 Millimoles per Liter (mmol/L)
Standard Deviation 0.0883
|
0.0109 Millimoles per Liter (mmol/L)
Standard Deviation 0.07972
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Phosphate
|
-0.0058 Millimoles per Liter (mmol/L)
Standard Deviation 0.07409
|
-0.0021 Millimoles per Liter (mmol/L)
Standard Deviation 0.0965
|
-0.0021 Millimoles per Liter (mmol/L)
Standard Deviation 0.11269
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Sodium
|
-1.1 Millimoles per Liter (mmol/L)
Standard Deviation 1.45
|
0.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.95
|
0.5 Millimoles per Liter (mmol/L)
Standard Deviation 2.47
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
Triglycerides
|
0.1801 Millimoles per Liter (mmol/L)
Standard Deviation 0.37021
|
0.0082 Millimoles per Liter (mmol/L)
Standard Deviation 0.30805
|
0.1558 Millimoles per Liter (mmol/L)
Standard Deviation 0.44508
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters- Bicarbonate, Calcium, Glucose, Chloride, Magnesium, Phosphate, Potassium, Sodium, BUN, Cholesterol, HDL, LDL, Triglycerides Edit Properties | Duplicate Measure
BUN
|
0.504 Millimoles per Liter (mmol/L)
Standard Deviation 0.81856
|
0.4046 Millimoles per Liter (mmol/L)
Standard Deviation 1.00855
|
0.6426 Millimoles per Liter (mmol/L)
Standard Deviation 0.91715
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Amylase
|
12 Units per liter (U/L)
|
-0.7 Units per liter (U/L)
Standard Deviation 6.12
|
-1.2 Units per liter (U/L)
Standard Deviation 17.38
|
-0.7 Units per liter (U/L)
Standard Deviation 4.46
|
3.7 Units per liter (U/L)
Standard Deviation 4.76
|
5.8 Units per liter (U/L)
Standard Deviation 12.02
|
-1.7 Units per liter (U/L)
Standard Deviation 11.52
|
3.7 Units per liter (U/L)
Standard Deviation 17.24
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Lipase
|
-31 Units per liter (U/L)
|
-15.5 Units per liter (U/L)
Standard Deviation 25.76
|
7.8 Units per liter (U/L)
Standard Deviation 25.41
|
-8 Units per liter (U/L)
Standard Deviation 20.01
|
-1.3 Units per liter (U/L)
Standard Deviation 3.93
|
3.7 Units per liter (U/L)
Standard Deviation 3.67
|
3.7 Units per liter (U/L)
Standard Deviation 4.27
|
3.8 Units per liter (U/L)
Standard Deviation 5.19
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Amylase
|
-18.3 Units per liter (U/L)
Standard Deviation 17.85
|
0.3 Units per liter (U/L)
Standard Deviation 5.50
|
3.7 Units per liter (U/L)
Standard Deviation 27.96
|
7.2 Units per liter (U/L)
Standard Deviation 15.30
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Lipase
|
-6.3 Units per liter (U/L)
Standard Deviation 8.62
|
1.1 Units per liter (U/L)
Standard Deviation 2.54
|
3.8 Units per liter (U/L)
Standard Deviation 22.06
|
1.2 Units per liter (U/L)
Standard Deviation 2.48
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Amylase
|
-10 Units per liter (U/L)
Standard Deviation 22.5
|
—
|
2.7 Units per liter (U/L)
Standard Deviation 7.51
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Lipase
|
-1.9 Units per liter (U/L)
Standard Deviation 4.67
|
—
|
-2.0 Units per liter (U/L)
Standard Deviation 5.57
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Amylase and Lipase. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Amylase
|
1.2 Units per liter (U/L)
Standard Deviation 12.08
|
5.1 Units per liter (U/L)
Standard Deviation 18.24
|
0.5 Units per liter (U/L)
Standard Deviation 16.41
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameters - Amylase and Lipase
Lipase
|
-0.6 Units per liter (U/L)
Standard Deviation 6.25
|
2.7 Units per liter (U/L)
Standard Deviation 10.06
|
0.4 Units per liter (U/L)
Standard Deviation 18.92
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Direct Bilirubin
|
0 Micromoles per Liter (umol/L)
|
-0.1995 Micromoles per Liter (umol/L)
Standard Deviation 0.62518
|
-0.2839 Micromoles per Liter (umol/L)
Standard Deviation 1.10348
|
0.4895 Micromoles per Liter (umol/L)
Standard Deviation 0.46819
|
-0.285 Micromoles per Liter (umol/L)
Standard Deviation 1.28724
|
0.2565 Micromoles per Liter (umol/L)
Standard Deviation 1.18349
|
-0.3705 Micromoles per Liter (umol/L)
Standard Deviation 0.86801
|
-0.855 Micromoles per Liter (umol/L)
Standard Deviation 1.43069
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Total Bilirubin
|
-1.71 Micromoles per Liter (umol/L)
|
-0.855 Micromoles per Liter (umol/L)
Standard Deviation 2.8098
|
-0.19 Micromoles per Liter (umol/L)
Standard Deviation 3.2598
|
0.57 Micromoles per Liter (umol/L)
Standard Deviation 0.883
|
0.285 Micromoles per Liter (umol/L)
Standard Deviation 2.5171
|
0.285 Micromoles per Liter (umol/L)
Standard Deviation 2.7396
|
-1.71 Micromoles per Liter (umol/L)
Standard Deviation 2.163
|
-3.135 Micromoles per Liter (umol/L)
Standard Deviation 3.8109
|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine
|
-8.84 Micromoles per Liter (umol/L)
|
6.188 Micromoles per Liter (umol/L)
Standard Deviation 8.27379
|
1.8171 Micromoles per Liter (umol/L)
Standard Deviation 5.38547
|
6.0407 Micromoles per Liter (umol/L)
Standard Deviation 3.93024
|
4.5673 Micromoles per Liter (umol/L)
Standard Deviation 8.82968
|
-0.442 Micromoles per Liter (umol/L)
Standard Deviation 3.65553
|
3.978 Micromoles per Liter (umol/L)
Standard Deviation 4.80135
|
3.536 Micromoles per Liter (umol/L)
Standard Deviation 2.56208
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Direct Bilirubin
|
0.5863 Micromoles per Liter (umol/L)
Standard Deviation 1.10758
|
-0.8061 Micromoles per Liter (umol/L)
Standard Deviation 0.95062
|
-0.6058 Micromoles per Liter (umol/L)
Standard Deviation 1.12324
|
0.2817 Micromoles per Liter (umol/L)
Standard Deviation 1.28814
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Total Bilirubin
|
0.244 Micromoles per Liter (umol/L)
Standard Deviation 3.6178
|
-0.977 Micromoles per Liter (umol/L)
Standard Deviation 2.7674
|
0.19 Micromoles per Liter (umol/L)
Standard Deviation 3.9593
|
1.425 Micromoles per Liter (umol/L)
Standard Deviation 3.8109
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine
|
-1.768 Micromoles per Liter (umol/L)
Standard Deviation 5.35289
|
-0.6314 Micromoles per Liter (umol/L)
Standard Deviation 4.55680
|
3.536 Micromoles per Liter (umol/L)
Standard Deviation 7.48795
|
8.3980 Micromoles per Liter (umol/L)
Standard Deviation 2.89164
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Direct Bilirubin
|
1.4671 Micromoles per Liter (umol/L)
Standard Deviation 0.64254
|
—
|
0.5700 Micromoles per Liter (umol/L)
Standard Deviation 0.98727
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Total Bilirubin
|
1.71 Micromoles per Liter (umol/L)
Standard Deviation 1.71
|
—
|
-1.140 Micromoles per Liter (umol/L)
Standard Deviation 2.6121
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine
|
2.2731 Micromoles per Liter (umol/L)
Standard Deviation 2.88068
|
—
|
-1.1787 Micromoles per Liter (umol/L)
Standard Deviation 2.55189
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Total Bilirubin, Direct Bilirubin and Creatinine. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Direct Bilirubin
|
0.4124 Micromoles per Liter (umol/L)
Standard Deviation 1.068
|
0.2059 Micromoles per Liter (umol/L)
Standard Deviation 1.11784
|
0.3306 Micromoles per Liter (umol/L)
Standard Deviation 0.89198
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Total Bilirubin
|
0.905 Micromoles per Liter (umol/L)
Standard Deviation 3.7813
|
1.026 Micromoles per Liter (umol/L)
Standard Deviation 3.5282
|
0.456 Micromoles per Liter (umol/L)
Standard Deviation 1.9886
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameter - Total Bilirubin, Direct Bilirubin and Creatinine
Creatinine
|
1.716 Micromoles per Liter (umol/L)
Standard Deviation 6.168
|
2.9467 Micromoles per Liter (umol/L)
Standard Deviation 6.70465
|
3.0645 Micromoles per Liter (umol/L)
Standard Deviation 6.90318
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Clinical Chemistry Parameter - Total Protein
|
2 Grams per Liter (g/L)
|
4.5 Grams per Liter (g/L)
Standard Deviation 3.83
|
3.2 Grams per Liter (g/L)
Standard Deviation 3.07
|
6.3 Grams per Liter (g/L)
Standard Deviation 3.33
|
1 Grams per Liter (g/L)
Standard Deviation 4.15
|
3.7 Grams per Liter (g/L)
Standard Deviation 2.88
|
4 Grams per Liter (g/L)
Standard Deviation 3.85
|
3.5 Grams per Liter (g/L)
Standard Deviation 1.97
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 - (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Clinical Chemistry Parameter - Total Protein
|
-7.1 Grams per Liter (g/L)
Standard Deviation 6.26
|
-5.4 Grams per Liter (g/L)
Standard Deviation 3.91
|
-3.7 Grams per Liter (g/L)
Standard Deviation 3.84
|
2.0 Grams per Liter (g/L)
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Clinical Chemistry Parameter - Total Protein
|
-2.1 Grams per Liter (g/L)
Standard Deviation 4.49
|
—
|
-1.7 Grams per Liter (g/L)
Standard Deviation 5.03
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected to assess change from baseline in Total Protein. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Clinical Chemistry Parameter - Total Protein
|
5.4 Grams per Liter (g/L)
Standard Deviation 4.87
|
4.5 Grams per Liter (g/L)
Standard Deviation 4.02
|
5.1 Grams per Liter (g/L)
Standard Deviation 5.38
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 27 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to detect presence of occult blood and protein through dipstick and random method respectively. The results presented are worst case abnormal urinalysis results post-baseline relative to baseline.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=21 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Number of Participants With Abnormal Urinalysis Parameters
Occult Blood
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Part 1 - Number of Participants With Abnormal Urinalysis Parameters
Protein
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 5 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to detect presence of occult blood and protein through dipstick and random method respectively. The results presented are worst case abnormal urinalysis results post-baseline relative to baseline.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=7 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=3 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=7 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 - Number of Participants With Abnormal Urinalysis Parameters
Occult Blood
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Part 2 - Number of Participants With Abnormal Urinalysis Parameters
Protein
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 16 weeksPopulation: Safety Population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to detect presence of occult blood and protein through dipstick and random method respectively. The results presented are worst case abnormal urinalysis results post-baseline relative to baseline.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Number of Participants With Abnormal Urinalysis Parameters
Occult Blood
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Number of Participants With Abnormal Urinalysis Parameters
Protein
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP
|
0.5 Millimeters of mercury (mmHg)
|
-0.1 Millimeters of mercury (mmHg)
Standard Deviation 14.68
|
5.3 Millimeters of mercury (mmHg)
Standard Deviation 7.82
|
4.6 Millimeters of mercury (mmHg)
Standard Deviation 7.07
|
2.3 Millimeters of mercury (mmHg)
Standard Deviation 7.30
|
1.3 Millimeters of mercury (mmHg)
Standard Deviation 8.04
|
2.4 Millimeters of mercury (mmHg)
Standard Deviation 6.34
|
5.5 Millimeters of mercury (mmHg)
Standard Deviation 8.95
|
|
Part 1 - Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP
|
1.8 Millimeters of mercury (mmHg)
|
3.0 Millimeters of mercury (mmHg)
Standard Deviation 8.20
|
4.0 Millimeters of mercury (mmHg)
Standard Deviation 4.36
|
3.7 Millimeters of mercury (mmHg)
Standard Deviation 9.57
|
1.7 Millimeters of mercury (mmHg)
Standard Deviation 6.15
|
-1.2 Millimeters of mercury (mmHg)
Standard Deviation 4.05
|
2.7 Millimeters of mercury (mmHg)
Standard Deviation 8.13
|
4.7 Millimeters of mercury (mmHg)
Standard Deviation 7.06
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=7 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP
|
-2.1 Millimeters of mercury (mmHg)
Standard Deviation 11.58
|
-2.1 Millimeters of mercury (mmHg)
Standard Deviation 5.57
|
-6.0 Millimeters of mercury (mmHg)
Standard Deviation 15.26
|
-0.8 Millimeters of mercury (mmHg)
Standard Deviation 4.08
|
—
|
—
|
—
|
—
|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP
|
0.8 Millimeters of mercury (mmHg)
Standard Deviation 7.21
|
1.4 Millimeters of mercury (mmHg)
Standard Deviation 5.45
|
-3.4 Millimeters of mercury (mmHg)
Standard Deviation 8.73
|
0.0 Millimeters of mercury (mmHg)
Standard Deviation 6.17
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP
|
1.5 Millimeters of mercury (mmHg)
Standard Deviation 5.42
|
—
|
1.0 Millimeters of mercury (mmHg)
Standard Deviation 11.89
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP
|
0.9 Millimeters of mercury (mmHg)
Standard Deviation 6.52
|
—
|
4.2 Millimeters of mercury (mmHg)
Standard Deviation 9.56
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 6Population: Safety Population
Blood pressure (SBP and DBP) was assessed in semi-supine position with a completely automated device. Blood pressure measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline is defined as the average of the triplicate predose assessments within each treatment. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP
|
3.8 Millimeters of mercury (mmHg)
Standard Deviation 10.10
|
9.3 Millimeters of mercury (mmHg)
Standard Deviation 8.08
|
6.2 Millimeters of mercury (mmHg)
Standard Deviation 7.20
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Change From Baseline in Vital Signs - Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP
|
3.4 Millimeters of mercury (mmHg)
Standard Deviation 8.63
|
4.4 Millimeters of mercury (mmHg)
Standard Deviation 5.79
|
2.3 Millimeters of mercury (mmHg)
Standard Deviation 4.02
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Vital Signs - Pulse Rate
|
15.7 Beats per minute
|
3.5 Beats per minute
Standard Deviation 7.40
|
1.5 Beats per minute
Standard Deviation 5.03
|
-0.2 Beats per minute
Standard Deviation 3.45
|
5.9 Beats per minute
Standard Deviation 2.64
|
4.8 Beats per minute
Standard Deviation 5.74
|
-0.9 Beats per minute
Standard Deviation 7.98
|
0.0 Beats per minute
Standard Deviation 9.71
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Pulse Rate
|
-2.8 Beats per minute
Standard Deviation 4.98
|
5.0 Beats per minute
Standard Deviation 5.49
|
1.1 Beats per minute
Standard Deviation 4.59
|
3.0 Beats per minute
Standard Deviation 4.75
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Pulse Rate
|
5.2 Beats per minute
Standard Deviation 5.29
|
—
|
0.9 Beats per minute
Standard Deviation 1.60
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 6Population: Safety Population
Pulse rate was assessed in semi-supine position with a completely automated device. Pulse rate measurement preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Vital Signs - Pulse Rate
|
7.4 Beats per minute
Standard Deviation 4.98
|
6.6 Beats per minute
Standard Deviation 5.48
|
6.2 Beats per minute
Standard Deviation 6.80
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Temperature was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=18 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Vital Signs - Body Temperature
|
-0.10 Degrees Celsius
|
0.12 Degrees Celsius
Standard Deviation 0.248
|
-0.06 Degrees Celsius
Standard Deviation 0.320
|
-0.05 Degrees Celsius
Standard Deviation 0.226
|
0.10 Degrees Celsius
Standard Deviation 0.190
|
0.02 Degrees Celsius
Standard Deviation 0.117
|
0.08 Degrees Celsius
Standard Deviation 0.286
|
0.20 Degrees Celsius
Standard Deviation 0.155
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Body temperature were assessed at indicated time-points. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=7 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Body Temperature
|
-0.07 Degrees Celsius
Standard Deviation 0.170
|
0.09 Degrees Celsius
Standard Deviation 0.135
|
0.16 Degrees Celsius
Standard Deviation 0.283
|
-0.08 Degrees Celsius
Standard Deviation 0.204
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population
Body temperature were assessed at indicated time-points. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Body Temperature
|
-0.06 Degrees Celsius
Standard Deviation 0.113
|
—
|
-0.07 Degrees Celsius
Standard Deviation 0.153
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 6Population: Safety Population
Body temperature were assessed at indicated time-points. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Vital Signs - Body Temperature
|
0.06 Degrees Celsius
Standard Deviation 0.237
|
0.15 Degrees Celsius
Standard Deviation 0.233
|
0.08 Degrees Celsius
Standard Deviation 0.231
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 6Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=1 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=21 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Change From Baseline in Vital Signs - Respiratory Rate
|
-5.0 Breaths per minute
|
-3.0 Breaths per minute
Standard Deviation 1.41
|
0.7 Breaths per minute
Standard Deviation 2.97
|
3.7 Breaths per minute
Standard Deviation 1.03
|
0.7 Breaths per minute
Standard Deviation 2.07
|
0.3 Breaths per minute
Standard Deviation 1.51
|
0.3 Breaths per minute
Standard Deviation 1.51
|
0.7 Breaths per minute
Standard Deviation 3.27
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 14Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=7 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QD PBO and Cohort 3, 4 and 5) - Change From Baseline in Vital Signs - Respiratory Rate
|
-3.4 Breaths per minute
Standard Deviation 1.51
|
0.0 Breaths per minute
Standard Deviation 1.63
|
-0.4 Breaths per minute
Standard Deviation 2.19
|
1.2 Breaths per minute
Standard Deviation 3.13
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 15Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (QW PBO and Cohort 6) - Change From Baseline in Vital Signs - Respiratory Rate
|
-1.4 Breaths per minute
Standard Deviation 2.23
|
—
|
0.0 Breaths per minute
Standard Deviation 2.00
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and Day 6Population: Safety Population
Respiratory rate was assessed in the semi-recumbent position with a completely automated device, preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first dose of study drug administration. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Change From Baseline in Vital Signs - Respiratory Rate
|
-0.3 Breaths per minute
Standard Deviation 2.31
|
1.2 Breaths per minute
Standard Deviation 2.24
|
0.4 Breaths per minute
Standard Deviation 2.03
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 27 weeksPopulation: Safety Population
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. ECG findings were categorized as Normal, Abnormal clinically significant (CS) and Abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline ECG findings have been presented.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=21 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Findings
Normal
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1 - Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Findings
Abnormal - Not Clinically Significant
|
4 Participants
|
6 Participants
|
20 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Part 1 - Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Findings
Abnormal - Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 5 weeksPopulation: Safety Population
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. ECG findings were categorized as Normal, Abnormal clinically significant (CS) and Abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline ECG findings have been presented.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=9 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=7 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=3 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=7 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 - Number of Participants With Worst Case Post-Baseline ECG Findings
Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 2 - Number of Participants With Worst Case Post-Baseline ECG Findings
Abnormal - Not Clinically Significant
|
7 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
—
|
—
|
|
Part 2 - Number of Participants With Worst Case Post-Baseline ECG Findings
Abnormal - Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 16 weeksPopulation: Safety Population
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. ECG findings were categorized as Normal, Abnormal clinically significant (CS) and Abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline ECG findings have been presented.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=17 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Number of Participants With Worst Case Post-Baseline ECG Findings
Normal
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Number of Participants With Worst Case Post-Baseline ECG Findings
Abnormal - Not Clinically Significant
|
16 Participants
|
14 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 3 - Number of Participants With Worst Case Post-Baseline ECG Findings
Abnormal - Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 12, 16 and 24 hours post-dose in each treatment periodPopulation: Pharmacokinetic (PK) Population: The PK Population included all participants who undergo plasma or urine PK sampling and have evaluable PK assay results. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=16 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hours (AUC[0-24]) of GSK3739937
|
8646.757 Hour*nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 33.9
|
3522.969 Hour*nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 91
|
6455.362 Hour*nanogram/ millilitre (h*ng/mL)
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3739937
|
58892.29 h*ng/mL
Geometric Coefficient of Variation 23.6
|
27326.99 h*ng/mL
Geometric Coefficient of Variation 64
|
43323.02 h*ng/mL
Geometric Coefficient of Variation 27.3
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=16 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 - Maximum Observed Concentration (Cmax) of GSK3739937
|
524.99 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 31.8
|
227.88 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 93.5
|
389.81 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 23.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12 and 24 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2) - AUC(0-24) of GSK3739937
|
1976.944 h*ng/mL
Geometric Coefficient of Variation 24.3
|
5027.183 h*ng/mL
Geometric Coefficient of Variation 27.4
|
637.8486 h*ng/mL
Geometric Coefficient of Variation 38.8
|
9490.296 h*ng/mL
Geometric Coefficient of Variation 15.4
|
13743.02 h*ng/mL
Geometric Coefficient of Variation 23.6
|
23829.99 h*ng/mL
Geometric Coefficient of Variation 53.1
|
42129.36 h*ng/mL
Geometric Coefficient of Variation 18.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2) - AUC From Zero (Pre-dose) to Time of the Last Quantifiable Concentration (t) (AUC [0-t]) of GSK3739937
|
11441.28 h*ng/mL
Geometric Coefficient of Variation 31.5
|
33650.11 h*ng/mL
Geometric Coefficient of Variation 42.5
|
2486.061 h*ng/mL
Geometric Coefficient of Variation 46.4
|
64937.76 h*ng/mL
Geometric Coefficient of Variation 18.4
|
90730.34 h*ng/mL
Geometric Coefficient of Variation 25.9
|
158068.4 h*ng/mL
Geometric Coefficient of Variation 70
|
293636.9 h*ng/mL
Geometric Coefficient of Variation 33.6
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=5 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=4 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=5 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=5 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=3 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2) - AUC(0-inf) of GSK3739937
|
12788.34 h*ng/mL
Geometric Coefficient of Variation 32.4
|
40287.05 h*ng/mL
Geometric Coefficient of Variation 15.5
|
NA h*ng/mL
Geometric Coefficient of Variation NA
'NA' refers to not quantifiable as the GSK3739937 concentration was below the lower limit of quantification (10 ng/mL)
|
75181.6 h*ng/mL
Geometric Coefficient of Variation 13.6
|
107211.7 h*ng/mL
Geometric Coefficient of Variation 25.2
|
190803.9 h*ng/mL
Geometric Coefficient of Variation 81.6
|
302147.5 h*ng/mL
Geometric Coefficient of Variation 34.2
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=5 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=4 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=5 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=5 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=3 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2) - Apparent Terminal Phase Half-life (T1/2) of GSK3739937
|
75.8706 Hours
Geometric Coefficient of Variation 7.4
|
79.0711 Hours
Geometric Coefficient of Variation 14.4
|
NA Hours
Geometric Coefficient of Variation NA
'NA' refers to not quantifiable as the GSK3739937 concentration was below the lower limit of quantification (10 ng/mL)
|
91.8314 Hours
Geometric Coefficient of Variation 13.6
|
96.7684 Hours
Geometric Coefficient of Variation 22.7
|
82.6113 Hours
Geometric Coefficient of Variation 9
|
67.4404 Hours
Geometric Coefficient of Variation 9.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=5 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=4 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=5 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=5 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=3 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2) - Apparent Oral Clearance (CL/F) of GSK3739937
|
2.3459 litre/ hour (L/h)
Geometric Coefficient of Variation 32.4
|
1.9857 litre/ hour (L/h)
Geometric Coefficient of Variation 15.5
|
NA litre/ hour (L/h)
Geometric Coefficient of Variation NA
'NA' refers to not quantifiable as the GSK3739937 concentration was below the lower limit of quantification (10 ng/mL)
|
2.1282 litre/ hour (L/h)
Geometric Coefficient of Variation 13.6
|
2.9847 litre/ hour (L/h)
Geometric Coefficient of Variation 25.2
|
3.3542 litre/ hour (L/h)
Geometric Coefficient of Variation 81.6
|
2.6477 litre/ hour (L/h)
Geometric Coefficient of Variation 34.2
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2) - Cmax of GSK3739937
|
127.3 ng/mL
Geometric Coefficient of Variation 22.9
|
310.43 ng/mL
Geometric Coefficient of Variation 21
|
39.22 ng/mL
Geometric Coefficient of Variation 41.6
|
528.63 ng/mL
Geometric Coefficient of Variation 13.5
|
1014.31 ng/mL
Geometric Coefficient of Variation 30.7
|
1458.44 ng/mL
Geometric Coefficient of Variation 52
|
2863.33 ng/mL
Geometric Coefficient of Variation 22.2
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 12, 16 and 24 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2) - Concentration of GSK3739937 at 24 Hours (C24) of GSK3739937
|
85.3 ng/mL
Geometric Coefficient of Variation 25.9
|
247.73 ng/mL
Geometric Coefficient of Variation 40
|
29.46 ng/mL
Geometric Coefficient of Variation 37.9
|
429.55 ng/mL
Geometric Coefficient of Variation 19.4
|
612.15 ng/mL
Geometric Coefficient of Variation 14.6
|
1126.32 ng/mL
Geometric Coefficient of Variation 71.1
|
2645.7 ng/mL
Geometric Coefficient of Variation 31.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2) - Last Quantifiable Concentration (Clast) of GSK3739937
|
14.41 ng/mL
Geometric Coefficient of Variation 23.7
|
18.24 ng/mL
Geometric Coefficient of Variation 54.1
|
15.09 ng/mL
Geometric Coefficient of Variation 31.1
|
39.54 ng/mL
Geometric Coefficient of Variation 38.7
|
51.33 ng/mL
Geometric Coefficient of Variation 70.4
|
78.7 ng/mL
Geometric Coefficient of Variation 72.8
|
83.43 ng/mL
Geometric Coefficient of Variation 58.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2 ) - Time of Occurrence of Cmax (Tmax) of GSK3739937
|
8 Hours
Interval 5.0 to 12.1
|
7.98 Hours
Interval 5.0 to 24.1
|
6.98 Hours
Interval 6.0 to 8.0
|
7.95 Hours
Interval 7.95 to 24.0
|
6.99 Hours
Interval 6.0 to 8.0
|
7 Hours
Interval 5.0 to 24.2
|
18.08 Hours
Interval 12.1 to 24.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2) - Lag Time (Tlag) of GSK3739937
|
1.99 Hours
Interval 1.5 to 3.0
|
1.23 Hours
Interval 0.9 to 2.0
|
3.47 Hours
Interval 2.5 to 4.6
|
1 Hours
Interval 0.5 to 1.5
|
1 Hours
Interval 0.0 to 1.1
|
0.5 Hours
Interval 0.0 to 1.0
|
0 Hours
Interval 0.0 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 192, 264 and 360 hours post-dose in each treatment period.Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 Participants
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 Participants
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort 1 and 2) - Time to Reach Clast (Tlast) of GSK3739937
|
261.967 Hours
Interval 192.07 to 287.8
|
359.967 Hours
Interval 263.38 to 383.82
|
95.7 Hours
Interval 95.55 to 192.15
|
358.942 Hours
Interval 335.88 to 363.72
|
359.642 Hours
Interval 359.23 to 360.62
|
359.9 Hours
Interval 336.27 to 430.33
|
360.334 Hours
Interval 358.93 to 362.85
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3, 4 and 5) - AUC (0-24) of GSK3739937 on Day 1
|
3559.102 h*ng/mL
Geometric Coefficient of Variation 26.3
|
5893.917 h*ng/mL
Geometric Coefficient of Variation 54.8
|
1888.173 h*ng/mL
Geometric Coefficient of Variation 24.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3, 4 and 5) - Cmax of GSK3739937 on Day 1
|
232.07 ng/mL
Geometric Coefficient of Variation 30
|
375.26 ng/mL
Geometric Coefficient of Variation 50.2
|
132.12 ng/mL
Geometric Coefficient of Variation 23.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3, 4 and 5) - C24 of GSK3739937 on Day 1
|
188.65 ng/mL
Geometric Coefficient of Variation 41.1
|
271.59 ng/mL
Geometric Coefficient of Variation 75.3
|
89.33 ng/mL
Geometric Coefficient of Variation 26.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3, 4 and 5) - Tmax of GSK3739937 on Day 1
|
8 Hours
Interval 7.0 to 23.8
|
9 Hours
Interval 6.0 to 23.8
|
9 Hours
Interval 6.0 to 16.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3, 4 and 5) - Tlag of GSK3739937 on Day 1
|
2 Hours
Interval 1.0 to 2.0
|
1.03 Hours
Interval 0.9 to 2.0
|
2 Hours
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3 and 4) - Tmax of GSK3739937 on Day 14
|
7.03 Hour
Interval 3.0 to 9.0
|
—
|
6.95 Hour
Interval 0.0 to 9.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3 and 4) - Cmax of GSK3739937 on Day 14
|
1149.32 ng/mL
Geometric Coefficient of Variation 15.1
|
—
|
766.32 ng/mL
Geometric Coefficient of Variation 16
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3 and 4) - AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3739937 on Day 14
|
24888.49 h*ng/mL
Geometric Coefficient of Variation 14.4
|
—
|
14592.19 h*ng/mL
Geometric Coefficient of Variation 12.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3 and 4) - Plasma Trough Concentration (Ctau) of GSK3739937 on Day 14
|
990.3205 ng/mL
Geometric Coefficient of Variation 13.2
|
—
|
588.1557 ng/mL
Geometric Coefficient of Variation 22.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=6 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=3 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3 and 4) - T1/2 of GSK3739937 on Day 14
|
72.2484 Hours
Geometric Coefficient of Variation 28.4
|
—
|
85.7725 Hours
Geometric Coefficient of Variation 25.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 14Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3 and 4) - CL/F of GSK3739937 on Day 14
|
2.009 L/h
Geometric Coefficient of Variation 14.4
|
—
|
1.7132 L/h
Geometric Coefficient of Variation 12.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5) - Tmax of GSK3739937 on Day 18
|
—
|
—
|
9.01 Hours
Interval 8.1 to 24.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5) - Cmax of GSK3739937 on Day 18
|
—
|
—
|
2748 ng/mL
Geometric Coefficient of Variation 21.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5) - AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) on Day 18
|
—
|
—
|
58417.64 h*ng/mL
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5) - Plasma Trough Concentration (Ctau) of GSK3739937 on Day 18
|
—
|
—
|
2458.275 ng/mL
Geometric Coefficient of Variation 21.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5) - T1/2 of GSK3739937 on Day 18
|
—
|
—
|
78.5264 Hours
Geometric Coefficient of Variation 26.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 18Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=6 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5) - CL/F of GSK3739937 on Day 18
|
—
|
—
|
1.7118 Litre/ hour (L/h)
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and up to 168 hours post-dose from Day 1Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - AUC From Zero to 168 Hours (AUC[0-168]) of GSK3739937 From Day 1
|
—
|
—
|
96434.63 h*ng/mL
Geometric Coefficient of Variation 14.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - Cmax of GSK3739937 on Day 1
|
—
|
—
|
1106.61 ng/mL
Geometric Coefficient of Variation 12.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and up to 168 hours post-dose from Day 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - Concentration of GSK3739937 at 168 Hours (C168) From Day 1
|
—
|
—
|
250.62 ng/mL
Geometric Coefficient of Variation 36.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - Tmax of GSK3739937 on Day 1
|
—
|
—
|
9.88 Hours
Interval 8.0 to 48.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - Tlag of GSK3739937 on Day 1
|
—
|
—
|
0 Hours
Interval 0.0 to 1.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6 ) - AUC(0-t) of GSK3739937 on Day 15
|
—
|
—
|
169693.1 h*ng/mL
Geometric Coefficient of Variation 31.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - Cmax of GSK3739937 on Day 15
|
—
|
—
|
1855.67 ng/mL
Geometric Coefficient of Variation 24.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - Ctau of GSK3739937 on Day 15
|
—
|
—
|
455.4447 ng/mL
Geometric Coefficient of Variation 46.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - Tmax of GSK3739937 on Day 15
|
—
|
—
|
10 Hours
Interval 9.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - T1/2 of GSK3739937 on Day 15
|
—
|
—
|
74.5404 Hours
Geometric Coefficient of Variation 19.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on Day 15Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - CL/F of GSK3739937 on Day 15
|
—
|
—
|
2.9465 L/h
Geometric Coefficient of Variation 31.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=16 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 (Cohort 7) - C24 of GSK3739937
|
407.5 ng/mL
Geometric Coefficient of Variation 39.7
|
153.97 ng/mL
Geometric Coefficient of Variation 91.2
|
316.7 ng/mL
Geometric Coefficient of Variation 29.4
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=16 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 (Cohort 7) Clast of GSK3739937
|
25.09 ng/mL
Geometric Coefficient of Variation 51.6
|
15.44 ng/mL
Geometric Coefficient of Variation 37
|
19.76 ng/mL
Geometric Coefficient of Variation 40.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=16 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 (Cohort 7) - Tmax of GSK3739937
|
8.42 Hours
Interval 5.0 to 15.9
|
6 Hours
Interval 4.0 to 47.7
|
9 Hours
Interval 7.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=16 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 (Cohort 7) - Tlag of GSK3739937
|
2 Hours
Interval 0.0 to 3.0
|
0.98 Hours
Interval 0.0 to 3.0
|
1 Hours
Interval 0.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=16 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=15 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 (Cohort 7) - Tlast of GSK3739937
|
360.067 Hours
Interval 120.08 to 362.27
|
267.4 Hours
Interval 195.12 to 361.15
|
336.75 Hours
Interval 263.63 to 389.92
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=10 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=13 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 (Cohort 7) - T1/2 of GSK3739937
|
72.9842 Hours
Geometric Coefficient of Variation 17.5
|
72.8066 Hours
Geometric Coefficient of Variation 16.9
|
74.7429 Hours
Geometric Coefficient of Variation 21.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 48, 72, 96, 120, 192, 264, and 360 hours post-dose in each treatment periodPopulation: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=15 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=10 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=13 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 3 (Cohort 7) - CL/F of GSK3739937
|
1.698 L/h
Geometric Coefficient of Variation 23.6
|
3.6594 L/h
Geometric Coefficient of Variation 64
|
2.3082 L/h
Geometric Coefficient of Variation 27.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 16Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 30 mg, 80 mg, 160 mg, 320 mg, 640 mg and 800 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=28 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Dose Proportionality of GSK3739937 for Dose Levels 30 mg to 800 mg Using AUC(0-infinity) After Single Dose Administration of GSK3739937
|
—
|
—
|
0.882 Slope of log dose
Interval 0.784 to 0.976
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 16Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 10 mg, 30 mg, 80 mg, 160 mg, 320 mg, 640 mg and 800 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=42 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 - Dose Proportionality of GSK3739937 for Dose Levels 10 mg to 800 mg Using Cmax After Single Dose Administration of GSK3739937
|
—
|
—
|
0.914 Slope of log dose
Interval 0.855 to 0.966
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 33Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 25 mg, 50 mg and 100 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=21 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 - Dose Proportionality of GSK3739937 for Dose Levels 25 mg to 100 mg Using AUC(0-24) After Repeated Dose Administration of GSK3739937
|
—
|
—
|
0.997 Slope of log dose
Interval 0.864 to 1.109
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 33Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 25 mg, 50 mg and 100 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=28 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 - Dose Proportionality of GSK3739937 for Dose Levels 25 mg to 100 mg Using Cmax After Repeated Dose Administration of GSK3739937
|
—
|
—
|
0.914 Slope of log dose
Interval 0.777 to 1.066
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 33Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality for dose 25 mg, 50 mg and 100 mg was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=27 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 - Dose Proportionality of GSK3739937 for Dose Levels 25 mg to 100 mg Using Ctau After Repeated Dose Administration of GSK3739937
|
—
|
—
|
1.023 Slope of log dose
Interval 0.878 to 1.184
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 14Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 14 AUC(0-tau) / day 1 AUC(0-tau).
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3 and 4) - Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}])
|
6.993 Ratio
Interval 6.025 to 8.117
|
—
|
7.728 Ratio
Interval 6.418 to 9.305
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 18Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 18 AUC(0-tau) / day 1 AUC(0-tau).
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5) - Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}])
|
—
|
—
|
9.943 Ratio
Interval 6.987 to 14.149
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 15Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 15 AUC(0-tau) / day 1 AUC(0-tau).
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}])
|
—
|
—
|
1.76 Ratio
Interval 1.448 to 2.138
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 14Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 14 Cmax / day 1 Cmax.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3 and 4) - Accumulation Ratio of Cmax (R [CMAX])
|
4.952 Ratio
Interval 4.198 to 5.842
|
—
|
5.8 Ratio
Interval 4.962 to 6.78
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 18Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Actual measure type is Ratio. Accumulation ratio calculated as the ratio of day 18 Cmax / day 1 Cmax.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5) - Accumulation Ratio of Cmax (R [CMAX])
|
—
|
—
|
7.325 Ratio
Interval 5.333 to 10.06
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 15Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 15 Cmax / day 1 Cmax.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - Accumulation Ratio of Cmax (R [CMAX])
|
—
|
—
|
1.677 Ratio
Interval 1.381 to 2.036
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 14Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 14 C(Tau) / day 1 C(Tau).
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3 and 4) - Accumulation Ratio of C(Tau) (R[CTAU])
|
5.25 Ratio
Interval 4.07 to 6.771
|
—
|
6.584 Ratio
Interval 5.256 to 8.248
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 18Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 18 C(Tau) / day 1 C(Tau).
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5) - Accumulation Ratio of C(Tau) (R[CTAU])
|
—
|
—
|
9.133 Ratio
Interval 5.562 to 14.995
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 and 16 hours post-dose on both Day 1 and Day 15Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio calculated as the ratio of day 15 C(Tau) / day 1 C(Tau).
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 6) - Accumulation Ratio of C(Tau) (R[CTAU])
|
—
|
—
|
1.817 Ratio
Interval 1.428 to 2.313
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 15Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. For Part 2 cohorts 3 and 4, steady-state GSK3739937 concentrations was assessed by estimating the slope of concentrations on pre-dose assessments on Days 2-14 (Part 2 cohort 3 and 4) and the day 15 (24-hr post-dose relative to dosing on day 14). PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
n=7 Participants
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 3 and 4) - Pre-dose Concentration of GSK3739937
|
57.1056 Slope of log dose
Interval 51.9304 to 62.2808
|
—
|
37.1872 Slope of log dose
Interval 33.0332 to 41.3412
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 19Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for PK analysis of GSK3739937. For Part 2 cohort 5, steady state GSK3739937 concentrations was assessed by estimating the slope of the concentrations of pre-dose assessments on Days 2-18 and the day 19 (24-hr post-dose relative to dosing on day 18). PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
GSK3739937 Tablet Fed
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
Placebo (PBO) Single Dose
n=7 Participants
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 SD 80 mg
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
|---|---|---|---|---|---|---|---|---|
|
Part 2 (Cohort 5) - Pre-dose Concentration of GSK3739937
|
—
|
—
|
114.9742 Slope of log dose
Interval 103.8293 to 126.119
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo (PBO) Single Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GSK3739937 Single Dose (SD) 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GSK3739937 SD 30 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GSK3739937 SD 80 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GSK3739937 SD 160 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GSK3739937 SD 320 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GSK3739937 SD 640 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GSK3739937 SD 800 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PBO Once Daily (QD)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GSK3739937 QD 25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GSK3739937 QD 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GSK3739937 QD 100 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PBO Once Weekly (QW)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GSK3739937 QW 500 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GSK3739937 PiB Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GSK3739937 Tablet Fed
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GSK3739937 Tablet Fasted
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (PBO) Single Dose
n=21 participants at risk
In Cohort 1 and 2 of Part 1, participants received single oral dose of Placebo.
|
GSK3739937 Single Dose (SD) 10 mg
n=6 participants at risk
In Cohort 1 of Part 1, participants received single oral dose of 10 mg GSK3739937
|
GSK3739937 SD 30 mg
n=6 participants at risk
In Cohort 2 of Part 1, participants received single oral dose of 30 mg GSK3739937
|
GSK3739937 SD 80 mg
n=6 participants at risk
In Cohort 1 of Part 1, participants received single oral dose of 80 mg GSK3739937
|
GSK3739937 SD 160 mg
n=6 participants at risk
In Cohort 2 of Part 1, participants received single oral dose of 160 mg GSK3739937
|
GSK3739937 SD 320 mg
n=6 participants at risk
In Cohort 1 of Part 1, participants received single oral dose of 320 mg GSK3739937
|
GSK3739937 SD 640 mg
n=6 participants at risk
In Cohort 2 of Part 1, participants received single oral dose of 640 mg GSK3739937
|
GSK3739937 SD 800 mg
n=6 participants at risk
In Cohort 1 of Part 1, participants received single oral dose of 800 mg of GSK3739937
|
PBO Once Daily (QD)
n=9 participants at risk
Participants received once daily doses of Placebo for 14 days
|
GSK3739937 QD 25 mg
n=7 participants at risk
In Cohort 3 of Part 2, participants received once-daily oral dose of 25 mg GSK3739937 for 14 days.
|
GSK3739937 QD 50 mg
n=7 participants at risk
In Cohort 4 of Part 2, participants received once-daily oral dose of 50 mg GSK3739937 for 14 days.
|
GSK3739937 QD 100 mg
n=7 participants at risk
In Cohort 5 of Part 2, participants received once-daily oral dose of 100 mg GSK3739937 for 18 days.
|
PBO Once Weekly (QW)
n=3 participants at risk
Participants received once weekly oral dose of Placebo for over 3 weeks.
|
GSK3739937 QW 500 mg
n=7 participants at risk
In Cohort 6 of Part 2, participants received one dose per week of 500 mg GSK3739937 for over 3 weeks.
|
GSK3739937 PiB Fed
n=15 participants at risk
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 PiB as an oral suspension under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fed
n=17 participants at risk
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under moderate fed conditions in each one of the three periods.
|
GSK3739937 Tablet Fasted
n=15 participants at risk
In Cohort 7 of Part 3, participants received single oral dose of 100 mg of GSK3739937 Tablet under fasted conditions in each one of the three periods.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Vessel puncture site pain
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Eye disorders
Dry eye
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Eye disorders
Eye irritation
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
11.1%
1/9 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
1/21 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
33.3%
2/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
33.3%
2/6 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
42.9%
3/7 • Number of events 4 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
11.1%
1/9 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
5.9%
1/17 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
General disorders
Medical device site dermatitis
|
4.8%
1/21 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
66.7%
4/6 • Number of events 4 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
11.1%
1/9 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
General disorders
Vaccination site pain
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
11.1%
1/9 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Infections and infestations
COVID-19
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
5.9%
1/17 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Burn oral cavity
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
5.9%
1/17 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
11.1%
1/9 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
13.3%
2/15 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
5.9%
1/17 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Investigations
SARS-CoV-2 test positive
|
4.8%
1/21 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
11.1%
1/9 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
11.8%
2/17 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
13.3%
2/15 • Number of events 2 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
11.1%
1/9 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Reproductive system and breast disorders
Premenstrual pain
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
11.1%
1/9 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
14.3%
1/7 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
5.9%
1/17 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
16.7%
1/6 • Number of events 1 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/6 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/9 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/3 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/7 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/17 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
0.00%
0/15 • All cause mortality, Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 27 weeks in Part 1, up to 5 weeks in Part 2 and up to 16 weeks in Part 3.
Safety population included all randomized participants who received at least one dose of study treatment. Data is presented treatment-wise.
|
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