Trial Outcomes & Findings for A First Time in Human (FTIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK3884464 in Healthy Participants (NCT NCT05044325)
NCT ID: NCT05044325
Last Updated: 2024-05-02
Results Overview
An AE is defined as 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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Up to Day 17
Results posted on
2024-05-02
Participant Flow
Total of 27 participants were enrolled in both Part 1 and Part 2 together.
This was a two parts study with single dose escalation in Part 1 and repeat dose in Part 2 in healthy participants. Part 1 was a 3-period crossover design with 3 cohorts, randomized to 3 periods in a 1:1:1 ratio. Within each period, allocation to GSK3884464 and placebo were a 2:1 ratio. Part 2 was a sequential design with 3 cohorts. The study was terminated after dosing 2 sentinel participants in Cohort 4 (which was first cohort to receive repeat doses). Hence, Cohort 5 and 6 were not conducted.
Participant milestones
| Measure |
Part 1 Cohort 1 (C1): Placebo C1/ GSK3884464 3 Milligrams (mg)/ GSK3884464 9mg
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C1/ GSK3884464 3 milligrams (mg)/ GSK3884464 9mg across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 1: GSK3884464 1 mg/ Placebo C1/ GSK3884464 9mg
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 1 mg/ Placebo C1/ GSK3884464 9mg across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 1: GSK3884464 1 mg/ GSK3884464 3 mg / Placebo C1
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 1 mg/ GSK3884464 3 mg / Placebo C1 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 2 (C2): Placebo C2/ GSK3884464 110 mg/ SD6
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C2/ GSK3884464 110 mg/ Single Dose (SD) 6 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 2: GSK3884464 30 mg/ Placebo C2/ SD6
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 30 mg/ Placebo C2/ SD6 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 2: GSK3884464 30 mg/ GSK3884464 110 mg / Placebo C2
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 30 mg/ GSK3884464 110 mg / Placebo C2 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 3 (C3): Placebo C3/ SD8/ SD9
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C3/ SD8/ SD9 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 3: GSK3884464 70 mg/ SD8/ Placebo C3
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 70 mg/ SD8/ Placebo C3 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 2 Cohort 4 (C4): GSK3884464 15 mg
Participants received GSK3884464 15 mg through oral administration.
|
Part 2 Cohort 4: Placebo C4
Participants received placebo through oral administration in Cohort 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
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Part A:Treatment Period 1
STARTED
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3
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3
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3
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3
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3
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3
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1
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1
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0
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0
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Part A:Treatment Period 1
COMPLETED
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3
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3
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2
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1
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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 A:Treatment Period 1
NOT COMPLETED
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0
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0
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1
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2
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2
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3
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1
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1
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0
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0
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Part A:Treatment Period 2
STARTED
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3
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3
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3
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1
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2
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2
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0
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0
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0
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0
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Part A:Treatment Period 2
COMPLETED
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3
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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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Part A:Treatment Period 2
NOT COMPLETED
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0
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1
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0
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1
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2
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2
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0
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0
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0
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0
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Part A:Treatment Period 3
STARTED
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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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Part A:Treatment Period 3
COMPLETED
|
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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Part A:Treatment Period 3
NOT COMPLETED
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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 B
STARTED
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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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1
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Part B
COMPLETED
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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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1
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Part B
NOT COMPLETED
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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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Reasons for withdrawal
| Measure |
Part 1 Cohort 1 (C1): Placebo C1/ GSK3884464 3 Milligrams (mg)/ GSK3884464 9mg
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C1/ GSK3884464 3 milligrams (mg)/ GSK3884464 9mg across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 1: GSK3884464 1 mg/ Placebo C1/ GSK3884464 9mg
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 1 mg/ Placebo C1/ GSK3884464 9mg across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 1: GSK3884464 1 mg/ GSK3884464 3 mg / Placebo C1
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 1 mg/ GSK3884464 3 mg / Placebo C1 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 2 (C2): Placebo C2/ GSK3884464 110 mg/ SD6
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C2/ GSK3884464 110 mg/ Single Dose (SD) 6 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 2: GSK3884464 30 mg/ Placebo C2/ SD6
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 30 mg/ Placebo C2/ SD6 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 2: GSK3884464 30 mg/ GSK3884464 110 mg / Placebo C2
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 30 mg/ GSK3884464 110 mg / Placebo C2 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 3 (C3): Placebo C3/ SD8/ SD9
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C3/ SD8/ SD9 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 3: GSK3884464 70 mg/ SD8/ Placebo C3
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 70 mg/ SD8/ Placebo C3 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 2 Cohort 4 (C4): GSK3884464 15 mg
Participants received GSK3884464 15 mg through oral administration.
|
Part 2 Cohort 4: Placebo C4
Participants received placebo through oral administration in Cohort 4.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A:Treatment Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Part A:Treatment Period 1
Sponsor Terminated study treatment
|
0
|
0
|
0
|
2
|
2
|
2
|
0
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0
|
0
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0
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|
Part A:Treatment Period 1
Physician Decision
|
0
|
0
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0
|
0
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0
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0
|
1
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0
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0
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0
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|
Part A:Treatment Period 1
Withdrawal by Subject
|
0
|
0
|
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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|
Part A:Treatment Period 2
Adverse Event
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
0
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0
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0
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|
Part A:Treatment Period 2
Physician Decision
|
0
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0
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0
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0
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0
|
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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|
Part A:Treatment Period 2
Sponsor Terminated study treatment
|
0
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0
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0
|
1
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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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Baseline Characteristics
A First Time in Human (FTIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK3884464 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1 Cohort 1 (C1): Placebo C1/ GSK3884464 3 Milligrams (mg)/ GSK3884464 9mg
n=3 Participants
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C1/ GSK3884464 3 milligrams (mg)/ GSK3884464 9mg across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 1: GSK3884464 1 mg/ Placebo C1/ GSK3884464 9mg
n=4 Participants
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 1 mg/ Placebo C1/ GSK3884464 9mg across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 1: GSK3884464 1 mg/ GSK3884464 3 mg / Placebo C1
n=4 Participants
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 1 mg/ GSK3884464 3 mg / Placebo C1 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 2 (C2): Placebo C2/ GSK3884464 110 mg/ SD6
n=3 Participants
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C2/ GSK3884464 110 mg/ Single Dose (SD) 6 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 2: GSK3884464 30 mg/ Placebo C2/ SD6
n=4 Participants
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 30 mg/ Placebo C2/ SD6 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 2: GSK3884464 30 mg/ GSK3884464 110 mg / Placebo C2
n=5 Participants
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 30 mg/ GSK3884464 110 mg / Placebo C2 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 3 (C3): Placebo C3/ SD8/ SD9
n=1 Participants
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: Placebo C3/ SD8/ SD9 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 1 Cohort 3: GSK3884464 70 mg/ SD8/ Placebo C3
n=1 Participants
Participants received GSK3884464 or placebo through oral administration in the treatment sequence: GSK3884464 70 mg/ SD8/ Placebo C3 across 3 treatment periods. There was a minimum of 7 days washout period between dosing in each session.
|
Part 2 Cohort 4 (C4): GSK3884464 15 mg
n=1 Participants
Participants received GSK3884464 15 mg through oral administration.
|
Part 2 Cohort 4: Placebo C4
n=1 Participants
Participants received placebo through oral administration in Cohort 4.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.3 YEARS
STANDARD_DEVIATION 9.71 • n=5 Participants
|
37.5 YEARS
STANDARD_DEVIATION 6.61 • n=7 Participants
|
36.5 YEARS
STANDARD_DEVIATION 8.58 • n=5 Participants
|
44.0 YEARS
STANDARD_DEVIATION 6.08 • n=4 Participants
|
31.8 YEARS
STANDARD_DEVIATION 6.29 • n=21 Participants
|
36.6 YEARS
STANDARD_DEVIATION 6.15 • n=8 Participants
|
37.0 YEARS
n=8 Participants
|
36.0 YEARS
n=24 Participants
|
24.0 YEARS
n=42 Participants
|
46.0 YEARS
n=42 Participants
|
36.0 YEARS
STANDARD_DEVIATION 7.60 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
MULTIPLE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to Day 17Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention.
An AE is defined as 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.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=9 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 Participants
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 Participants
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 Participants
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Parts 1: Number of Participants With Adverse Events (AEs)
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 29Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention.
An AE is defined as 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.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=1 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Parts 2: Number of Participants With Adverse Events (AEs)
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 10Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected for analysis of chemistry parameters. PCI ranges were \>2\*Upper limit of normal (ULN) units per liter (U/L)(Alanine Aminotransferase \[ALT\]), \>2\*ULN (U/L) (Aspartate Aminotransferase (\[AST\]), \>2\*ULN (Alkaline Phosphatase \[ALP\]) (U/L), \>1.5\*ULN (micromoles per liter) (bilirubin), \<2 or \>2.75 millimoles/liter (L) (mmol/L)(calcium), \<3 or \>7.5 mmol/L (glucose), \<3 or \>5.3 mmol/L (potassium), \<130 or \>149 mmol/L (sodium). Participants were counted in worst case category that their value changes to (low, within \[w/in\] range or no change \[NC\], or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To within Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100 percentage (%).
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=3 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 Participants
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 Participants
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 Participants
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
2 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
5 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 10Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected for analysis of hematology parameters. The ranges for hematology parameters are as follows: Hematocrit\[\>51 percent(%)-male, \>45%-female\], Hemoglobin \[Higher: \>175 grams/Liter(g/L) in male, \>150g/L in female and Low: less than(\<) 100g/L in male, \<95g/L in female\], Lymphocytes\[\<0.97 10\^9/L\], Neutrophils\[\<1.5 10\^9/L\], Platelets\[High: \>550 10\^9/ L and Low: \<100 10\^9/ L\], White blood cells\[High:\>18 10\^9/L Low:\<2 10\^9/L\], Red blood cells\[Low: \<3.0 10\^12/L in male, \<2.5 10\^12/L\]. Participants were counted in worst case category that their value changes to (low, within range \[W/in\] or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example-High to High), or whose value became within range, were recorded in "To within Range or No Change" category. Participants were counted twice if participant has values that changed 'To Low' \& 'To High', so the percentages may not add to 100%.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=3 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 Participants
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 Participants
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 Participants
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
1 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Period 1 Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Period 3 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Period 2 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Period 2 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Period 1 Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Period 2 Worst Case Post-Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Period 3 Worst Case Post-Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Period 1 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Period 3 Worst Case Post-Baseline, To W/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 10Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Urine samples were collected to assess urine glucose, protein and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=9 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 Participants
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 Participants
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 Participants
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, No Change/Decreased
|
9 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Protein, No Change/Decreased
|
9 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Protein, Increase to TRACE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Ketones, No Change/Decreased
|
9 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Week 10Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT)/combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as (\[ALT/ALT ULN\]/\[ALP/ALP ULN\]) \>= 5 and ALT \>=3xULN.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=9 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 Participants
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 Participants
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 Participants
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >= 20xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >= 8xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >= 10xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >=3xULN and BIL >=2xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >3xULN and BIL >= 2xULN and (ALP <2xULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >3xULN and INR >1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
Hepatocellular injury
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
Hepatocellular injury and BIL >2xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT > 1.5xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >= 3xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >= 5xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 10Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention.
Twelve lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured QTc, PR, QRS intervals. Abnormal findings were categorized as clinically significant and not clinically significant. 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 abnormal ECG findings have been presented.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=9 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 Participants
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 Participants
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 Participants
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 1, Clinically Significant
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day -1, Not Clinically Significant
|
1 Participants
|
5 Participants
|
—
|
—
|
0 Participants
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day -1, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 1, Not Clinically Significant
|
1 Participants
|
3 Participants
|
—
|
—
|
1 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 1, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 2, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 2, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 3, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 3, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 4, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
1 Participants
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 4, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 5, Not Clinically Significant
|
0 Participants
|
1 Participants
|
—
|
—
|
0 Participants
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 5, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 6, Not Clinically Significant
|
0 Participants
|
1 Participants
|
—
|
—
|
1 Participants
|
2 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 1 Day 6, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day -1, Not Clinically Significant
|
1 Participants
|
—
|
1 Participants
|
—
|
2 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day -1, Clinically Significant
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 1, Not Clinically Significant
|
0 Participants
|
—
|
2 Participants
|
—
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 2, Not Clinically Significant
|
0 Participants
|
—
|
1 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 2, Clinically Significant
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 3, Not Clinically Significant
|
1 Participants
|
—
|
2 Participants
|
—
|
2 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 3, Clinically Significant
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 4, Not Clinically Significant
|
1 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 4, Clinically Significant
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 5, Not Clinically Significant
|
0 Participants
|
—
|
0 Participants
|
—
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 5, Clinically Significant
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 6, Not Clinically Significant
|
3 Participants
|
—
|
2 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 2 Day 6, Clinically Significant
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day -1, Not Clinically Significant
|
2 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day -1, Clinically Significant
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 1, Not Clinically Significant
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 1, Clinically Significant
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 2, Not Clinically Significant
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 2, Clinically Significant
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 3, Not Clinically Significant
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 3, Clinically Significant
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 4, Not Clinically Significant
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 4, Clinically Significant
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 5, Not Clinically Significant
|
1 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 5, Clinically Significant
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 6, Not Clinically Significant
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Period 3 Day 6, Clinically Significant
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Worst Case Post Baseline, Not Clinically Significant
|
8 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Laboratory Values
Worst Case Post Baseline, Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 10Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP), pulse rate (PR), body temperature, respiratory rate (RR) and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (millimeters of mercury\[mmHg\]): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), heart rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute):\<=8 (low) or \>20 (high) and body temperature (degrees Celsius) \<=35.5 (low) or \>38.0 (high). Participants were counted in worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To W/in Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100%.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=9 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 Participants
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 Participants
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 Participants
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 2 Worst Case Post Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 1 Worst Case Post Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 1 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 1 Worst Case Post Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 2 Worst Case Post Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 2 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 2 Worst Case Post Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 3 Worst Case Post Baseline, To Low
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 3 Worst Case Post Baseline, To w/in Range or No Change
|
2 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 3 Worst Case Post Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 1 Worst Case Post Baseline, To Low
|
1 Participants
|
1 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 1 Worst Case Post Baseline, To w/in Range or No Change
|
2 Participants
|
5 Participants
|
—
|
—
|
3 Participants
|
5 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 1 Worst Case Post Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 2 Worst Case Post Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 2 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 2 Worst Case Post Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 3 Worst Case Post Baseline, To Low
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 3 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
—
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 3 Worst Case Post Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 2 Worst Case Post Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 3 Worst Case Post Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 3 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 3 Worst Case Post Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 1 Worst Case Post Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 1 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 1 Worst Case Post Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 2 Worst Case Post Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 2 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 2 Worst Case Post Baseline, To High
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 3 Worst Case Post Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 3 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 3 Worst Case Post Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 1 Worst Case Post Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 1 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
6 Participants
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 1 Worst Case Post Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 2 Worst Case Post Baseline, To Low
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 2 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
—
|
6 Participants
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 3 Worst Case Post Baseline, To Low
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 3 Worst Case Post Baseline, To w/in Range or No Change
|
3 Participants
|
—
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 3 Worst Case Post Baseline, To High
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Upto Day 3Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Continuous cardiac telemetry was performed in a supine position after at least 5 minutes of rest. Number of participants who had abnormal findings upon cardiac telemetry assessment have been presented.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=9 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 Participants
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 Participants
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 Participants
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Worst Case Post Baseline, Clinically Significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 1 Day 2, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 1 Day 2, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 1 Day 3, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 1 Day 3, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 2 Day 2, Not Clinically Significant
|
2 Participants
|
—
|
3 Participants
|
—
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 2 Day 2, Clinically Significant
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 2 Day 3, Not Clinically Significant
|
2 Participants
|
—
|
3 Participants
|
—
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 2 Day 3, Clinically Significant
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 3 Day 2, Not Clinically Significant
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 3 Day 2, Clinically Significant
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 3 Day 3, Not Clinically Significant
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Period 3 Day 3, Clinically Significant
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Worst Case Post Baseline, Not Clinically Significant
|
4 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Upto Week 9Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted.
Blood samples were collected for analysis of chemistry parameters. PCI ranges were \>=2\*Upper limit of normal (ULN) units per liter (U/L)(Alanine Aminotransferase \[ALT\]), \>=2\*ULN (U/L) (Aspartate Aminotransferase (\[AST\]), \>=2\*ULN (Alkaline Phosphatase \[ALP\]) (U/L), \>=1.5\*ULN (micromoles per liter) (bilirubin), \<2 or \>2.75 millimoles/liter (L) (mmol/L)(calcium), \<3 or \>11 mmol/L (glucose), \<3 or \>5.5 mmol/L (potassium), \<130 or \>150 mmol/L (sodium),\<50 or \>85 grams/liter (protein). Participants were counted in worst case category that their value changes to (low, within \[w/in\] range or no change \[NC\], or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To within Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100 percentage (%)
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=1 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Worst Case Post-Baseline, To W/in Range or No Change
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
ALT, Worst Case Post-Baseline, To High
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Worst Case Post-Baseline, To W/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AP, Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Worst Case Post-Baseline, To W/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
AST, Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Worst Case Post-Baseline, To W/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Bilirubin, Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Worst Case Post-Baseline, To W/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Calcium, Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Worst Case Post-Baseline, To W/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Worst Case Post-Baseline, To W/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Potassium, Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Worst Case Post-Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Worst Case Post-Baseline, To W/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Sodium, Worst Case Post-Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Upto Week 9Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted.
Blood samples were collected for analysis of hematology parameters. The ranges for hematology parameters are as follows: Hematocrit\[\>51 % in male, \>45% in female\], Haemoglobin\[Higher: \> 175 grams/Litre (g/L) in male, \>150 g/L in female and Low: less than (\<) 100 g/L in male, \<95 g/L in female\], Lymphocytes\[\<0.97 10\^9/L\], Neutrophils\[\<1.5 10\^9/L\], Platelets\[High: \> 550 10\^9/ L and Low: \< 100 10\^9/ L\], White blood cells\[High:\>18 10\^9/L Low:\<2 10\^9/L\], Red blood cells\[Low: \<3.0 10\^12/L in male, \<2.5 10\^12/L\]. Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (for example \[e.g.\], High to High), or whose value became within range, were recorded in "To within Range or No Change" category. Participants were counted twice if participant has values that changed 'To Low' \& 'To High', so the percentages may not add to 100%.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=1 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Baseline, Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Baseline, W/in Range
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Erythrocytes, Baseline, High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Baseline, Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Baseline, W/in Range
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit, Baseline, High
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Baseline, Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Baseline, W/in Range
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin, Baseline, High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Baseline, Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Baseline, W/in Range
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes, Baseline, High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Baseline, Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Baseline, W/in Range
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils, Baseline, High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Baseline, Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Baseline, W/in Range
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets, Baseline, High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Upto Week 9Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted.
Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=1 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Glucose, No Change/Decreased
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Ketones, No Change/Decreased
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Ketones, Increase to TRACE
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Urinalysis Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Protein, No Change/Decreased
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Upto Week 9Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted.
Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT) in combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as (\[ALT/ALT ULN\]/\[ALP/ALP ULN\]) greater than or equal to (\>=) 5 and ALT \>=3xULN.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=1 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >= 20xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >=3xULN and BIL >=2xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >3xULN and BIL >= 2xULN and (ALP <2xULN)
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
Hepatocellular injury
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
Hepatocellular injury and BIL >2xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT > 1.5xULN
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >= 3xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >= 5xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >= 8xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Hepatobiliary Laboratory Values
ALT >= 10xULN
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Upto Week 9Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted.
Twelve lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured QTc, PR, QRS intervals. Abnormal findings were categorized as clinically significant and not clinically significant. 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 abnormal ECG findings have been presented.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=1 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 19, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 17, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 17, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 19, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Worst Case Post Baseline, Not Clinically Significant
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Worst Case Post Baseline, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 14, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 15, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 15, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 16, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 16, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 18, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 18, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day -1, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day -1, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 1, Not Clinically Significant
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 1, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 2, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 2, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 3, Not Clinically Significant
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 3, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 4, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 4, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 5, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 5, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 6, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 6, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 7, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 7, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 8, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 8, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 9, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 9, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 10, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 10, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 11, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 11, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 12, Not Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 12, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 13, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 13, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in 12-lead ECG Laboratory Values
Cohort 4 Day 14, Not Clinically Significant
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Upto Week 9Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted.
Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP), pulse rate (PR), body temperature, respiratory rate (RR) and were measured after resting for at least 5 minutes in semi-supine position. PCI ranges were, SBP (millimeters of mercury\[mmHg\]): \<85 (low) or \>160 (high), DBP (mmHg): \<45 (low) or \>100 (high), heart rate (beats per minute): \<40 (low) or \>110 (high), respiration rate (breaths per minute):\<=8 (low) or \>20 (high) and body temperature (degrees Celsius) \<=35.5 (low) or \>38.0 (high). Participants were counted in worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, are recorded in 'To W/in Range No Change' category. Participants were counted twice if participant had values that changed 'To Low' and 'To High', so percentages may not add to 100%.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=1 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 1 Worst Case Post Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 1 Worst Case Post Baseline, To w/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
DBP, Period 1 Worst Case Post Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 1 Worst Case Post Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 1 Worst Case Post Baseline, To w/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
PR, Period 1 Worst Case Post Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To w/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Systolic Blood Pressure, Period 1 Worst Case Post Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 1 Worst Case Post Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 1 Worst Case Post Baseline, To w/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
RR, Period 1 Worst Case Post Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 1 Worst Case Post Baseline, To Low
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 1 Worst Case Post Baseline, To w/in Range or No Change
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Temperature, Period 1 Worst Case Post Baseline, To High
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Upto Week 9Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted.
Echocardiography was performed at screening and Part 2 of the study using sound waves.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=1 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Echocardiogram
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Upto Day 14Population: The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study intervention. The study was terminated after dosing 2 sentinel participants in Cohort 4. Hence Cohort 5 and 6 were not conducted.
Continuous cardiac telemetry was performed in a supine position after at least 5 minutes of rest. Number of participants who had abnormal findings upon cardiac telemetry assessment have been presented.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=1 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 8, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 8, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 9, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 2, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 2, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 3, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 3, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 4, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 4, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 5, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 5, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 6, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 6, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 7, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 7, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 9, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 10, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 10, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 11, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 11, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 12, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 12, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 13, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 13, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 15, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Cohort 4 Day 15, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Worst Case Post Baseline, Not Clinically Significant
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Number of Participants With Clinically Significant Changes in Continuous Telemetry
Worst Case Post Baseline, Clinically Significant
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose,15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours post-dosePopulation: The analysis was performed on the Pharmacokinetic (PK) Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected at indicated time points for pharmacokinetic analysis of AUC\[0-t\].
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=6 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=3 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=1 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK3884464 Following Single Dose Administration
|
1031.06 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 35.88
|
3104.28 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 27.33
|
8510.99 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 30.70
|
23966.53 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 24.35
|
76886.06 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 11.20
|
99220.48 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose,15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected at indicated time points for pharmacokinetic analysis of AUC\[0-t\].
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=6 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=3 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=1 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: AUC From Time Zero to Infinity (AUC[0-inf]) of GSK3884464 Following Single Dose Administration
|
1177.89 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 39.36
|
3422.89 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 32.86
|
9632.76 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 36.64
|
27096.66 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 28.90
|
81971.94 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation 11.22
|
101162.62 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose,15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected at indicated time points for pharmacokinetic analysis of Cmax.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=6 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=5 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=3 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=1 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3884464 Following Single Dose Administration
|
70.69 Nanograms Per Milliliter (ng/mL)
Geometric Coefficient of Variation 17.52
|
211.56 Nanograms Per Milliliter (ng/mL)
Geometric Coefficient of Variation 23.51
|
551.75 Nanograms Per Milliliter (ng/mL)
Geometric Coefficient of Variation 23.60
|
1892.92 Nanograms Per Milliliter (ng/mL)
Geometric Coefficient of Variation 36.46
|
5093.44 Nanograms Per Milliliter (ng/mL)
Geometric Coefficient of Variation 22.38
|
6650.00 Nanograms Per Milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose,15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected at indicated time points for pharmacokinetic analysis of Tmax.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=6 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=5 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=3 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=1 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3884464 Following Single Dose Administration
|
0.51 Hour (h)
Interval 0.49 to 1.0
|
1.0 Hour (h)
Interval 0.51 to 1.01
|
1.01 Hour (h)
Interval 0.5 to 1.5
|
1.00 Hour (h)
Interval 0.5 to 4.0
|
1.51 Hour (h)
Interval 1.02 to 1.51
|
2.00 Hour (h)
Interval 2.0 to 2.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 pre-dose,15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected at indicated time points for pharmacokinetic analysis of T1/2.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=6 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=5 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=3 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=1 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Terminal Half-life (T1/2) of GSK3884464 Following Single Dose Administration
|
38.87 Hour (h)
Interval 28.78 to 76.1
|
32.39 Hour (h)
Interval 21.02 to 71.75
|
37.58 Hour (h)
Interval 26.9 to 76.11
|
31.845 Hour (h)
Interval 23.31 to 77.52
|
31.49 Hour (h)
Interval 21.29 to 39.5
|
21.50 Hour (h)
Interval 21.5 to 21.5
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received.
Blood samples were collected at indicated time points for pharmacokinetic analysis of AUC \[tau\] for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: AUC Over the Dosing Interval (AUC[Tau]) of GSK3884464 Following Repeat Dose Administration
|
11902.86 Hour*Picograms Per Milliliter (h*pg/mL)
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received.
Blood samples were collected at indicated time points for pharmacokinetic analysis of Cmax for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Cmax of GSK3884464 Following Repeat Dose Administration
Cohort 4 Day 1
|
754.00 Nanograms Per Milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Cmax of GSK3884464 Following Repeat Dose Administration
Cohort 4 Day 14
|
1120.00 Nanograms Per Milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (NQ values were considered as valid PK assessment). This population was based on the treatment the participant actually received.
Blood samples were collected at indicated time points for pharmacokinetic analysis of Ctau for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Trough Plasma Concentration (Ctau) of GSK3884464 Following Repeat Dose Administration
Cohort 4 Day 1
|
246.00 Nanograms Per Milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Trough Plasma Concentration (Ctau) of GSK3884464 Following Repeat Dose Administration
Cohort 4 Day 14
|
415.99 Nanograms Per Milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received.
Blood samples were collected at indicated time points for pharmacokinetic analysis of Tmax for repeat dose administration. NA indicates full range could not be calculated for single participant.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Tmax of GSK3884464 Following Repeat Dose Administration
Cohort 4 Day 1
|
0.57 Hour (h)
NA indicates full range could not be calculated for single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Tmax of GSK3884464 Following Repeat Dose Administration
Cohort 4 Day 14
|
0.57 Hour (h)
NA indicates full range could not be calculated for single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received.
Blood samples were collected at indicated time points for pharmacokinetic analysis of T1/2 for repeat dose administration. NA indicates full range could not be calculated for single participant.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: T1/2 of GSK3884464 Following Repeat Dose Administration
Cohort 4 Day 1
|
70.59 Hour (h)
NA indicates full range could not be calculated for single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: T1/2 of GSK3884464 Following Repeat Dose Administration
Cohort 4 Day 14
|
45.05 Hour (h)
NA indicates full range could not be calculated for single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received.
Blood samples were collected at indicated time points for pharmacokinetic analysis of RAUC for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Accumulation Ratio Based on AUC(Tau) (RAUC) of GSK3884464 Following Repeat Dose Administration
|
1.77 Ratio
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received.
Blood samples were collected at indicated time points for pharmacokinetic analysis of RCmax for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Accumulation Ratio Based on Cmax (RCmax) of GSK3884464 Following Repeat Dose Administration
|
1.49 Ratio
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dosePopulation: The analysis was performed on the PK Set that includes all participants in the Safety population who had at least one non-missing PK assessment (Non-quantifiable \[NQ\] values were considered as valid PK assessment). This population was based on the treatment the participant actually received.
Blood samples were collected at indicated time points for pharmacokinetic analysis of RCtau for repeat dose administration. NA indicates geometric coefficient of variation could not be calculated for single participant.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Accumulation Ratio Based on Ctau (RCtau) of GSK3884464 Following Repeat Dose Administration
|
1.68 Ratio
Geometric Coefficient of Variation NA
NA indicates geometric coefficient of variation could not be calculated for single participant.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day1: pre-dose,30 minutes,1,1.5,2,3,4,6, 8,12,18,24 hours post-dosePopulation: The analysis was performed on the Pharmacodynamic (PD) Set that includes all participants in the Safety population with baseline and at least one post baseline PD measure (e.g., NQO1 mRNA). Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Blood samples were collected at indicated time points for pharmacodynamic analysis of NQO1 mRNA.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=9 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 Participants
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 Participants
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 Participants
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 Participants
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 Participants
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 Participants
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 Participants
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Change From Baseline in NAD(P)H Dehydrogenase Quinone 1 (NQO1) Messenger Ribonucleic Acid (mRNA) in Whole Blood Post Treatment With GSK3884464
|
1.19 Fold Change
Standard Deviation 0.17
|
1.17 Fold Change
Standard Deviation 0.11
|
1.13 Fold Change
Standard Deviation 0.10
|
1.31 Fold Change
Standard Deviation 0.29
|
1.16 Fold Change
Standard Deviation 0.20
|
2.79 Fold Change
Standard Deviation 0.69
|
7.66 Fold Change
Standard Deviation 1.52
|
0.96 Fold Change
Standard Deviation NA
NA indicates standard deviation could not be calculated for single participant.
|
8.5830 Fold Change
Standard Deviation NA
NA indicates standard deviation could not be calculated for single participant.
|
SECONDARY outcome
Timeframe: Day 1: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours post-dose; Day 4 and Day 11: pre-dose; Day 7: pre-dose, 6 and 12 hours post-dose; Day 14: pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96 and 120 hours post-dosePopulation: The analysis was performed on the PD Set that includes all participants in the Safety population with baseline and at least one post baseline PD measure (e.g., NQO1 mRNA).
Blood samples were collected at indicated time points for pharmacodynamic analysis of NQO1 mRNA for repeat dose administration. NA indicates standard deviation could not be calculated for single participant.
Outcome measures
| Measure |
Part 1 Cohort 1: Placebo C1
n=1 Participants
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=1 Participants
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464
Cohort 4 Day 1
|
1.035 Fold Change
Standard Deviation NA
NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
|
1.684 Fold Change
Standard Deviation NA
NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464
Cohort 4 Day 7
|
1.095 Fold Change
Standard Deviation NA
NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
|
2.560 Fold Change
Standard Deviation NA
NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Cohorts 4: Change From Baseline in NQO1 mRNA in Whole Blood Post Treatment With GSK3884464
Cohort 4 Day 14
|
1.029 Fold Change
Standard Deviation NA
NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
|
2.405 Fold Change
Standard Deviation NA
NA indicate that data is not available since only one participant was analyzed, therefore Standard Deviation was not derived.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 Cohort 1: Placebo C1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort 1: GSK3884464 1 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort 1: GSK3884464 3 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 Cohort 1: GSK3884464 9 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort 2: Placebo C2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort 2: GSK3884464 30 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort 2: GSK3884464 110 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort 3: Placebo C3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort 3: GSK3884464 70 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 Cohort 4: Placebo C4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2 Cohort 4: GSK3884464 15 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 Cohort 1: Placebo C1
n=9 participants at risk
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 participants at risk
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 participants at risk
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 participants at risk
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 participants at risk
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 participants at risk
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 participants at risk
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 participants at risk
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 participants at risk
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
Part 2 Cohort 4: Placebo C4
n=1 participants at risk
Participants received placebo through oral administration in Cohort 4.
|
Part 2 Cohort 4: GSK3884464 15 mg
n=1 participants at risk
Participants received GSK3884464 15 mg through oral administration in Cohort 4.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Part 1 Cohort 1: Placebo C1
n=9 participants at risk
Participants received placebo through oral administration in Cohort 1.
|
Part 1 Cohort 1: GSK3884464 1 mg
n=6 participants at risk
Participants received GSK3884464 1 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 3 mg
n=6 participants at risk
Participants received GSK3884464 3 mg through oral administration.
|
Part 1 Cohort 1: GSK3884464 9 mg
n=6 participants at risk
Participants received GSK3884464 9 mg through oral administration.
|
Part 1 Cohort 2: Placebo C2
n=5 participants at risk
Participants received placebo through oral administration in Cohort 2.
|
Part 1 Cohort 2: GSK3884464 30 mg
n=6 participants at risk
Participants received GSK3884464 30 mg through oral administration.
|
Part 1 Cohort 2: GSK3884464 110 mg
n=3 participants at risk
Participants received GSK3884464 110 mg through oral administration.
|
Part 1 Cohort 3: Placebo C3
n=1 participants at risk
Participants received placebo through oral administration in Cohort 3.
|
Part 1 Cohort 3: GSK3884464 70 mg
n=1 participants at risk
Participants received GSK3884464 70 mg through oral administration in Cohort 3.
|
Part 2 Cohort 4: Placebo C4
n=1 participants at risk
Participants received placebo through oral administration in Cohort 4.
|
Part 2 Cohort 4: GSK3884464 15 mg
n=1 participants at risk
Participants received GSK3884464 15 mg through oral administration in Cohort 4.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
General disorders
Fatigue
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
100.0%
3/3 • Number of events 3 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
COVID-19
|
11.1%
1/9 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Infections and infestations
Furuncle
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
20.0%
1/5 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
2/6 • Number of events 2 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
33.3%
1/3 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
100.0%
1/1 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/9 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/6 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/5 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
16.7%
1/6 • Number of events 1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/3 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
0.00%
0/1 • All AEs and SAEs were collected up to Day 17 for Cohort 1, 2 and 3 of Part 1, up to Day 29 for Cohort 4 of Part 2.
Safety Set comprised of all randomized participants who received at least 1 dose of study intervention.
|
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