Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetic Investigation of GSK3882347 in Healthy Participants. (NCT NCT04488770)
NCT ID: NCT04488770
Last Updated: 2023-02-17
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (greater than or equal to \[\>=\]5 percent \[%\]) non-serious AEs is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
Up to 3 months
Results posted on
2023-02-17
Participant Flow
This was a 2-part, first-time-in-human (FTIH), dose-escalation, placebo (PBO)-controlled, single dose (SD) (Part 1) and repeat dose (RD) (Part 2) study to determine the safety, tolerability and pharmacokinetic (PK) profile of GSK3882347 in healthy participants. The study was conducted at a single center in the United Kingdom.
A total of 61 participants (21 participants in Part 1 and 40 participants in Part 2) were enrolled in the study.
Participant milestones
| Measure |
Part1-Cohort1:GSK3882347 SD 50mg/SD 150mg/SD 250 mg/SD PBO
Healthy participants in Part 1 Cohort 1 received a single dose (SD) of GSK3882347 50 milligrams (mg) on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of Placebo (PBO) on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part1-Cohort1:GSK3882347 SD 50mg/SD 150mg/SD PBO/SD 250mg Fed
Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of PBO on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part1-Cohort1: GSK3882347 SD 50mg/SD PBO/SD 250mg/SD 250mg Fed
Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part1-Cohort1:SD PBO/GSK3882347 SD 150mg/SD 250mg/SD 250mg Fed
Healthy participants in Part 1 Cohort 1 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
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Part 1-Cohort 2: SD PBO/GSK3882347 SD 900 mg/SD 15 mg
Healthy participants in Part 1 Cohort 2 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD PBO/SD 15 mg
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD PBO
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of PBO on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD 15 mg
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
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Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
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Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
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Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 1-Cohort 1: Period 1 (Up to 5 Days)
STARTED
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Part 1-Cohort 1: Period 1 (Up to 5 Days)
COMPLETED
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Part 1-Cohort 1: Period 1 (Up to 5 Days)
NOT COMPLETED
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Part 1-Cohort 1: Period 2 (Up to 5 Days)
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Part 1-Cohort 1: Period 2 (Up to 5 Days)
COMPLETED
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Part 1-Cohort 1: Period 2 (Up to 5 Days)
NOT COMPLETED
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Part 1-Cohort 1: Period 3 (Up to 5 Days)
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Part 1-Cohort 1: Period 3 (Up to 5 Days)
COMPLETED
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Part 1-Cohort 1: Period 3 (Up to 5 Days)
NOT COMPLETED
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Part 1-Cohort 1: Period 4 (Up to 5 Days)
STARTED
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Part 1-Cohort 1: Period 4 (Up to 5 Days)
COMPLETED
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Part 1-Cohort 1: Period 4 (Up to 5 Days)
NOT COMPLETED
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Part 1-Cohort 2: Period 1 (Up to 5 Days)
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Part 1-Cohort 2: Period 1 (Up to 5 Days)
COMPLETED
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Part 1-Cohort 2: Period 1 (Up to 5 Days)
NOT COMPLETED
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Part 1-Cohort 2: Period 2 (Up to 5 Days)
STARTED
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Part 1-Cohort 2: Period 2 (Up to 5 Days)
COMPLETED
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Part 1-Cohort 2: Period 2 (Up to 5 Days)
NOT COMPLETED
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Part 1-Cohort 2: Period 3 (Up to 5 Days)
STARTED
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Part 1-Cohort 2: Period 3 (Up to 5 Days)
COMPLETED
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2
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Part 1-Cohort 2: Period 3 (Up to 5 Days)
NOT COMPLETED
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Part 2 (Up to 26 Days)
STARTED
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8
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Part 2 (Up to 26 Days)
COMPLETED
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8
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Part 2 (Up to 26 Days)
NOT COMPLETED
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Reasons for withdrawal
| Measure |
Part1-Cohort1:GSK3882347 SD 50mg/SD 150mg/SD 250 mg/SD PBO
Healthy participants in Part 1 Cohort 1 received a single dose (SD) of GSK3882347 50 milligrams (mg) on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of Placebo (PBO) on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part1-Cohort1:GSK3882347 SD 50mg/SD 150mg/SD PBO/SD 250mg Fed
Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of PBO on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part1-Cohort1: GSK3882347 SD 50mg/SD PBO/SD 250mg/SD 250mg Fed
Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part1-Cohort1:SD PBO/GSK3882347 SD 150mg/SD 250mg/SD 250mg Fed
Healthy participants in Part 1 Cohort 1 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part 1-Cohort 2: SD PBO/GSK3882347 SD 900 mg/SD 15 mg
Healthy participants in Part 1 Cohort 2 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD PBO/SD 15 mg
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD PBO
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of PBO on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD 15 mg
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 2: Repeat Dose Placebo
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 50 mg
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 150 mg
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 500 mg
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 900 mg
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1-Cohort 1: Period 1 (Up to 5 Days)
Adverse Event
|
0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1-Cohort 1: Period 3 (Up to 5 Days)
Adverse Event
|
1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1-Cohort 2: Period 1 (Up to 5 Days)
Withdrawal by Subject
|
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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0
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0
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0
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0
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0
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0
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Part 1-Cohort 2: Period 2 (Up to 5 Days)
Physician Decision
|
0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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Baseline Characteristics
Safety, Tolerability and Pharmacokinetic Investigation of GSK3882347 in Healthy Participants.
Baseline characteristics by cohort
| Measure |
Part1-Cohort1:GSK3882347 SD 50mg/SD 150mg/SD 250 mg/SD PBO
n=3 Participants
Healthy participants in Part 1 Cohort 1 received a single dose (SD) of GSK3882347 50 milligrams (mg) on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of Placebo (PBO) on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part1-Cohort1:GSK3882347 SD 50mg/SD 150mg/SD PBO/SD 250mg Fed
n=2 Participants
Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of PBO on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part1-Cohort1: GSK3882347 SD 50mg/SD PBO/SD 250mg/SD 250mg Fed
n=2 Participants
Healthy participants in Part 1 Cohort 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part1-Cohort1:SD PBO/GSK3882347 SD 150mg/SD 250mg/SD 250mg Fed
n=3 Participants
Healthy participants in Part 1 Cohort 1 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 150 mg on Day 1 in treatment Period 2, followed by a SD of GSK3882347 250 mg on Day 1 in treatment Period 3, further followed by a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4. Cohort 1 was a 4-period cross-over.
|
Part 1-Cohort 2: SD PBO/GSK3882347 SD 900 mg/SD 15 mg
n=3 Participants
Healthy participants in Part 1 Cohort 2 received a SD of PBO on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD PBO/SD 15 mg
n=3 Participants
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of PBO on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD PBO
n=3 Participants
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of PBO on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 1-Cohort 2: GSK3882347 SD 500 mg/SD 900 mg/SD 15 mg
n=2 Participants
Healthy participants in Part 1 Cohort 2 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1, followed by a SD of GSK3882347 900 mg on Day 1 in treatment Period 2, further followed by a SD of GSK3882347 15 mg on Day 1 in treatment Period 3. Cohort 2 was a 3-period cross-over.
|
Part 2: Repeat Dose Placebo
n=8 Participants
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 500 mg
n=8 Participants
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 900 mg
n=8 Participants
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
61 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
61 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
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
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian- South East Asian Heritage
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
White- White/Caucasian/European Heritage
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
51 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Mixed race
|
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
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Safety Population comprised of all participants who received at least one dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (greater than or equal to \[\>=\]5 percent \[%\]) non-serious AEs is presented.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=14 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Non-serious AEs
|
7 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 26 daysPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with common (\>=5%) non-serious AEs is presented.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Non-serious AEs and SAEs
Non-serious AEs
|
5 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Non-serious AEs and SAEs
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs is presented.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=14 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Treatment Related AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 26 daysPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with treatment related AEs is presented.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Treatment Related AEs
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Safety Population
Blood samples were collected to analyze hematocrit,hemoglobin,leukocytes,lymphocytes,neutrophils and platelets. PCI ranges were \<0.075 or \>0.54 proportion of red blood cells in blood for hematocrit, \<25 or \>180 grams per liter(g/L) for hemoglobin,\<3 or \>20 x10\^9 cells per liter(cells/L) for leukocytes,\<0.8 x10\^9 cells/L for lymphocytes,\<1.5 x10\^9 cells/L for neutrophils and \<100 or \>550 x10\^9 cells/L for platelets.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 the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=14 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit: To Low
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit: To within Range or No Change
|
12 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hematocrit: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Hemoglobin: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Leukocytes: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Lymphocytes: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Lymphocytes: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Lymphocytes: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Neutrophils: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline
Platelets: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 26 daysPopulation: Safety Population.
Blood samples were collected to analyze hematocrit,hemoglobin,leukocytes,lymphocytes,neutrophils and platelets. PCI ranges were \<0.075 or \>0.54 proportion of red blood cells in blood for hematocrit, \<25 or \>180 grams per liter(g/L) for hemoglobin,\<3 or \>20 x10\^9 cells per liter(cells/L) for leukocytes,\<0.8 x10\^9 cells/L for lymphocytes,\<1.5 x10\^9 cells/L for neutrophils and \<100 or \>550 x10\^9 cells/L for platelets.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, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Platelets: To within Range or No Change
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Platelets: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Hemoglobin: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Platelets: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Hematocrit: To Low
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Hematocrit: To within Range or No Change
|
6 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Hematocrit: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Hemoglobin: To Low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Hemoglobin: To within Range or No Change
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Leukocytes: To Low
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Leukocytes: To within Range or No Change
|
7 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Leukocytes: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Lymphocytes: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Lymphocytes: To within Range or No Change
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Lymphocytes: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Neutrophils: To Low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Neutrophils: To within Range or No Change
|
8 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Neutrophils: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Safety Population
Blood samples were collected to analyze PCI ranges: \>=2 times Upper limit of Normal(ULN) Units per Liter(U/L) for Alanine aminotransferase(ALT),\>=2 times ULN U/L for alkaline phosphatase(ALP), \>=2 times ULN U/L for aspartate aminotransferase(AST),\>=1.5 times ULN micromoles/L for bilirubin,\<2 or \>2.75 millimoles/L (mmol/L) for calcium,\<3 or \>9 mmol/L for glucose,\<3 or \>5.5 mmol/L for potassium and \<130 or \>150 mmol/L for sodium.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,were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value,including those from unscheduled visits
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=14 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALT: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALT: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALT: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALP: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALP: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALP: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
AST: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
AST: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
AST: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Bilirubin: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Bilirubin: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Bilirubin: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Calcium: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Calcium: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Calcium: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Glucose: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Glucose: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Glucose: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Potassium: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Potassium: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Potassium: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Sodium: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Sodium: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Sodium: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 26 daysPopulation: Safety Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to analyze PCI ranges: \>=2 times ULN U/L for Alanine aminotransferase(ALT),\>=2 times ULN U/L for alkaline phosphatase(ALP), \>=2 times ULN U/L for aspartate aminotransferase(AST),\>=1.5 times ULN micromoles/L for bilirubin,\<2 or \>2.75 mmol/L for calcium,\<3 or \>9 mmol/L for glucose,\<3 or \>5.5 mmol/L for potassium and \<130 or \>150 mmol/L for sodium.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,were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline=latest pre-dose assessment with a non-missing value,including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALT: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALT: To within Range or No Change
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALT: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALP: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALP: To within Range or No Change
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
ALP: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
AST: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
AST: To within Range or No Change
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
AST: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Bilirubin: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Bilirubin:To within Range or No Change
|
7 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Bilirubin: To High
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Calcium: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Calcium: To within Range or No Change
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Calcium: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Glucose: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Glucose: To within Range or No Change
|
4 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Glucose: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Potassium: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Potassium:To within Range or No Change
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Potassium: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Sodium: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Sodium: To within Range or No Change
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst-case Clinical Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline
Sodium: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Safety Population
Urine samples were collected for the analysis of urine parameters including occult blood and protein by dipstick. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to positive for urine occult blood and protein indicating proportional concentrations in the urine sample. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst case urinalysis results Post Baseline relative to Baseline is presented.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=14 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Occult Blood, No change/decreased
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Occult blood, Increase to positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Protein, No change/decreased
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Protein, Increase to positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 26 daysPopulation: Safety Population.
Urine samples were collected for the analysis of urine parameters including occult blood and protein by dipstick. The dipstick test gave results in a semi-quantitative manner (proportional concentrations in urine samples), and results for urinalysis parameters were recorded as no change/decreased, increase to positive for urine occult blood and protein. 'No change/decreased' indicates no change from Baseline results or decreased in results from Baseline including change in negative results. 'Increase to positive' indicates increase in result from Baseline. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst case urinalysis results Post Baseline relative to Baseline is presented.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Occult Blood, No change/decreased
|
8 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Occult blood, Increase to positive
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Protein, No change/decreased
|
7 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Post Baseline Relative to Baseline
Protein, Increase to trace
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Safety Population
Vital signs were assessed including Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). PCI ranges were \<85 (Low), 85-160 (Normal) and \>160 (High) for SBP; \<45 (Low), 45-100 (Normal), \>100 (High) for DBP; \<40 (Low), 40-110 (Normal), \>110 (High) for pulse rate. Participants were counted in worst case category that their value changes to(low,within range or no change, 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, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=14 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
DBP: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
SBP: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
SBP: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
SBP: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
DBP: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
DBP: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
PR: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
PR: To within Range or No Change
|
14 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
PR: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 26 daysPopulation: Safety Population.
Vital signs were assessed including Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). PCI ranges were \<85 (Low), 85-160 (Normal) and \>160 (High) for SBP; \<45 (Low), 45-100 (Normal), \>100 (High) for DBP; \<40 (Low), 40-110 (Normal), \>110 (High) for pulse rate. Participants were counted in worst case category that their value changes to(low,within range or no change, 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, were recorded in"To within Range or No Change" category.Participants were counted twice if the participant has values that changed 'To Low' and 'To High',so the percentages may not add to 100%.Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
SBP: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
SBP: To within Range or No Change
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
SBP: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
DBP: To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
DBP: To within Range or No Change
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
DBP: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
PR: To Low
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
PR: To within Range or No Change
|
7 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Vital Signs Results Relative to PCI Criteria Post Baseline Relative to Baseline
PR: To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Safety Population
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS 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. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=14 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline
Abnormal: NCS
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst Case Abnormal Electrocardiogram (ECG) Results Post Baseline Relative to Baseline
Abnormal: CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 26 daysPopulation: Safety Population.
A 12-lead ECG was recorded with the participant in a semi-supine position after a rest of at least 10 minutes. Twelve lead ECGs were obtained by using an automated ECG machine that measured PR, QRS, QT, and corrected QT (QTc) intervals and calculated heart rate. Data for abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings are presented. CS 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. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline
Abnormal: NCS
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Abnormal ECG Results Post Baseline Relative to Baseline
Abnormal: CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose in each treatment periodPopulation: PK Population comprised of all participants in the safety population who had at least 1 non-missing PK assessment.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347
|
1671.7 Hours*nanograms per milliliter
Geometric Coefficient of Variation 20.9
|
6514.1 Hours*nanograms per milliliter
Geometric Coefficient of Variation 12.3
|
17717.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 18.0
|
28472.2 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.9
|
21456.4 Hours*nanograms per milliliter
Geometric Coefficient of Variation 7.8
|
48381.2 Hours*nanograms per milliliter
Geometric Coefficient of Variation 26.9
|
65150.2 Hours*nanograms per milliliter
Geometric Coefficient of Variation 28.3
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of GSK3882347
|
1954.3 Hours*nanograms per milliliter
Geometric Coefficient of Variation 24.7
|
8249.8 Hours*nanograms per milliliter
Geometric Coefficient of Variation 18.2
|
22266.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 16.9
|
36561.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 26.7
|
29091.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 10.6
|
63052.2 Hours*nanograms per milliliter
Geometric Coefficient of Variation 26.1
|
88901.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.8
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3882347
|
2167.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 23.4
|
8425.5 Hours*nanograms per milliliter
Geometric Coefficient of Variation 18.1
|
22433.7 Hours*nanograms per milliliter
Geometric Coefficient of Variation 16.8
|
36768.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 26.5
|
29316.1 Hours*nanograms per milliliter
Geometric Coefficient of Variation 10.5
|
63377.3 Hours*nanograms per milliliter
Geometric Coefficient of Variation 26.1
|
89424.5 Hours*nanograms per milliliter
Geometric Coefficient of Variation 32.1
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347
|
165.7 Nanograms per milliliter
Geometric Coefficient of Variation 22.3
|
661.7 Nanograms per milliliter
Geometric Coefficient of Variation 14.8
|
1825.8 Nanograms per milliliter
Geometric Coefficient of Variation 21.2
|
3126.7 Nanograms per milliliter
Geometric Coefficient of Variation 31.3
|
1834.5 Nanograms per milliliter
Geometric Coefficient of Variation 13.4
|
4671.3 Nanograms per milliliter
Geometric Coefficient of Variation 27.4
|
5771.6 Nanograms per milliliter
Geometric Coefficient of Variation 24.6
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347
|
27.32 Nanograms per milliliter
Geometric Coefficient of Variation 29.7
|
106.70 Nanograms per milliliter
Geometric Coefficient of Variation 39.5
|
283.18 Nanograms per milliliter
Geometric Coefficient of Variation 24.7
|
500.35 Nanograms per milliliter
Geometric Coefficient of Variation 28.8
|
453.82 Nanograms per milliliter
Geometric Coefficient of Variation 13.6
|
853.98 Nanograms per milliliter
Geometric Coefficient of Variation 35.0
|
1291.37 Nanograms per milliliter
Geometric Coefficient of Variation 41.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Time to Cmax (Tmax) After Single Dose Administration of GSK3882347
|
3.000 Hours
Interval 2.0 to 4.0
|
4.000 Hours
Interval 2.0 to 4.18
|
4.000 Hours
Interval 2.0 to 6.0
|
4.000 Hours
Interval 2.0 to 6.0
|
4.000 Hours
Interval 2.0 to 8.0
|
4.000 Hours
Interval 2.0 to 4.0
|
4.000 Hours
Interval 2.0 to 8.0
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Lag Time for Absorption (Tlag) After Single Dose Administration of GSK3882347
|
0.375 Hours
Interval 0.25 to 0.5
|
0.250 Hours
Interval 0.0 to 0.5
|
0.250 Hours
Interval 0.0 to 0.5
|
0.250 Hours
Interval 0.0 to 0.25
|
0.250 Hours
Interval 0.25 to 1.5
|
0.250 Hours
Interval 0.25 to 0.5
|
0.250 Hours
Interval 0.25 to 0.5
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Terminal Elimination Half-life (T1/2) After Single Dose Administration of GSK3882347
|
11.407 Hours
Geometric Coefficient of Variation 17.7
|
12.269 Hours
Geometric Coefficient of Variation 14.5
|
11.538 Hours
Geometric Coefficient of Variation 10.1
|
12.277 Hours
Geometric Coefficient of Variation 16.0
|
12.984 Hours
Geometric Coefficient of Variation 10.3
|
12.630 Hours
Geometric Coefficient of Variation 11.6
|
12.690 Hours
Geometric Coefficient of Variation 13.8
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347
Day 1
|
5862.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 16.2
|
20191.4 Hours*nanograms per milliliter
Geometric Coefficient of Variation 25.6
|
45400.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 38.8
|
53753.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.8
|
—
|
—
|
—
|
—
|
|
Part 2: Area Under the Concentration-time Curve Over the Dosing Interval Tau (AUC[0-tau]) After Repeat Dose Administration of GSK3882347
Day 7
|
6144.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 8.7
|
21109.5 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.9
|
61202.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.4
|
82351.1 Hours*nanograms per milliliter
Geometric Coefficient of Variation 22.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Cmax After Repeat Dose Administration of GSK3882347
Day 1
|
586.0 Nanograms per milliliter
Geometric Coefficient of Variation 20.8
|
2179.1 Nanograms per milliliter
Geometric Coefficient of Variation 29.5
|
4409.4 Nanograms per milliliter
Geometric Coefficient of Variation 34.2
|
4933.1 Nanograms per milliliter
Geometric Coefficient of Variation 24.0
|
—
|
—
|
—
|
—
|
|
Part 2: Cmax After Repeat Dose Administration of GSK3882347
Day 7
|
600.4 Nanograms per milliliter
Geometric Coefficient of Variation 21.9
|
2007.4 Nanograms per milliliter
Geometric Coefficient of Variation 31.7
|
5370.3 Nanograms per milliliter
Geometric Coefficient of Variation 21.2
|
6575.2 Nanograms per milliliter
Geometric Coefficient of Variation 28.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Tmax After Repeat Dose Administration of GSK3882347
Day 1
|
4.000 Hours
Interval 2.0 to 6.0
|
3.000 Hours
Interval 1.5 to 4.0
|
4.000 Hours
Interval 4.0 to 6.0
|
4.008 Hours
Interval 4.0 to 6.0
|
—
|
—
|
—
|
—
|
|
Part 2: Tmax After Repeat Dose Administration of GSK3882347
Day 7
|
4.000 Hours
Interval 2.0 to 6.0
|
4.000 Hours
Interval 2.0 to 6.0
|
4.000 Hours
Interval 2.0 to 6.0
|
4.000 Hours
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347
Day 1
|
90.98 Nanograms per milliliter
Geometric Coefficient of Variation 46.8
|
292.53 Nanograms per milliliter
Geometric Coefficient of Variation 22.2
|
789.85 Nanograms per milliliter
Geometric Coefficient of Variation 46.7
|
1084.55 Nanograms per milliliter
Geometric Coefficient of Variation 31.8
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations Over the Dosing Interval (Ctau) After Repeat Dose Administration of GSK3882347
Day 7
|
109.28 Nanograms per milliliter
Geometric Coefficient of Variation 26.8
|
368.34 Nanograms per milliliter
Geometric Coefficient of Variation 29.7
|
1170.62 Nanograms per milliliter
Geometric Coefficient of Variation 39.2
|
1864.47 Nanograms per milliliter
Geometric Coefficient of Variation 23.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: 22-24 hours post-dose in each treatment periodPopulation: PK Population
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Urine Concentration Between 22-24 Hours (C22-24) After Single Dose Administration of GSK3882347
|
1.55 Micrograms per milliliter
Geometric Coefficient of Variation 71.3
|
2.99 Micrograms per milliliter
Geometric Coefficient of Variation 95.9
|
11.27 Micrograms per milliliter
Geometric Coefficient of Variation 146.7
|
15.26 Micrograms per milliliter
Geometric Coefficient of Variation 133.9
|
11.42 Micrograms per milliliter
Geometric Coefficient of Variation 148.0
|
48.54 Micrograms per milliliter
Geometric Coefficient of Variation 161.8
|
33.50 Micrograms per milliliter
Geometric Coefficient of Variation 75.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 7: 22-24 hours post-dosePopulation: PK Population
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347
Day 1
|
2.95 Micrograms per milliliter
Geometric Coefficient of Variation 52.5
|
11.98 Micrograms per milliliter
Geometric Coefficient of Variation 64.8
|
18.15 Micrograms per milliliter
Geometric Coefficient of Variation 42.8
|
38.43 Micrograms per milliliter
Geometric Coefficient of Variation 90.6
|
—
|
—
|
—
|
—
|
|
Part 2: Urine Concentration Between 22-24 Hours (C22-24) After Repeat Dose Administration of GSK3882347
Day 7
|
2.56 Micrograms per milliliter
Geometric Coefficient of Variation 84.4
|
16.50 Micrograms per milliliter
Geometric Coefficient of Variation 26.7
|
23.60 Micrograms per milliliter
Geometric Coefficient of Variation 69.6
|
57.15 Micrograms per milliliter
Geometric Coefficient of Variation 75.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment periodPopulation: PK Population
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Single Dose Administration of GSK3882347
|
11.16 Milligrams
Geometric Coefficient of Variation 15.7
|
32.01 Milligrams
Geometric Coefficient of Variation 9.4
|
106.86 Milligrams
Geometric Coefficient of Variation 25.5
|
146.43 Milligrams
Geometric Coefficient of Variation 20.5
|
95.17 Milligrams
Geometric Coefficient of Variation 9.2
|
306.93 Milligrams
Geometric Coefficient of Variation 20.8
|
430.03 Milligrams
Geometric Coefficient of Variation 22.5
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dosePopulation: PK Population
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347
Day 1
|
24.77 Milligrams
Geometric Coefficient of Variation 17.6
|
88.30 Milligrams
Geometric Coefficient of Variation 14.2
|
188.49 Milligrams
Geometric Coefficient of Variation 32.5
|
267.16 Milligrams
Geometric Coefficient of Variation 18.4
|
—
|
—
|
—
|
—
|
|
Part 2: Amount of Drug Excreted in Urine of Unchanged Drug (Ae Total) After Repeat Dose Administration of GSK3882347
Day 7
|
26.71 Milligrams
Geometric Coefficient of Variation 19.0
|
108.20 Milligrams
Geometric Coefficient of Variation 17.4
|
258.08 Milligrams
Geometric Coefficient of Variation 18.7
|
390.10 Milligrams
Geometric Coefficient of Variation 13.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment periodPopulation: PK Population
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. %fe was calculated as: (Ae total/Dose)\*100 percent (%).
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347
|
74.43 Percent dose excreted
Geometric Coefficient of Variation 15.7
|
64.02 Percent dose excreted
Geometric Coefficient of Variation 9.4
|
71.24 Percent dose excreted
Geometric Coefficient of Variation 25.5
|
58.57 Percent dose excreted
Geometric Coefficient of Variation 20.5
|
38.07 Percent dose excreted
Geometric Coefficient of Variation 9.2
|
61.39 Percent dose excreted
Geometric Coefficient of Variation 20.8
|
47.78 Percent dose excreted
Geometric Coefficient of Variation 22.5
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dosePopulation: PK Population
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. %fe was calculated as: (Ae total/Dose)\*100%.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347
Day 1
|
49.54 Percent dose excreted
Geometric Coefficient of Variation 17.6
|
58.87 Percent dose excreted
Geometric Coefficient of Variation 14.2
|
37.70 Percent dose excreted
Geometric Coefficient of Variation 32.5
|
29.68 Percent dose excreted
Geometric Coefficient of Variation 18.4
|
—
|
—
|
—
|
—
|
|
Part 2: Percentage of the Given Dose of Drug Excreted in Urine (%fe Total) After Single Dose Administration of GSK3882347
Day 7
|
53.42 Percent dose excreted
Geometric Coefficient of Variation 19.0
|
72.13 Percent dose excreted
Geometric Coefficient of Variation 17.4
|
51.62 Percent dose excreted
Geometric Coefficient of Variation 18.7
|
43.34 Percent dose excreted
Geometric Coefficient of Variation 13.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24, 24-26, 26-32, 32-38, 38-48, 48-60, 60-72, 72-84, 84-96 hours post-dose in each treatment periodPopulation: PK Population
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t)
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Renal Clearance of Drug (CLr) After Single Dose Administration of GSK3882347
|
5.71 Liters per hour
Geometric Coefficient of Variation 31.7
|
3.88 Liters per hour
Geometric Coefficient of Variation 25.8
|
4.80 Liters per hour
Geometric Coefficient of Variation 30.9
|
4.00 Liters per hour
Geometric Coefficient of Variation 19.1
|
3.27 Liters per hour
Geometric Coefficient of Variation 14.2
|
4.87 Liters per hour
Geometric Coefficient of Variation 17.5
|
4.84 Liters per hour
Geometric Coefficient of Variation 22.7
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 7: At 0-2, 2-4, 4-6, 6-8, 8-10, 10-12, 12-22, 22-24 hours post-dosePopulation: PK Population
Urine samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. CLr was calculated as: Ae total/AUC(0-t).
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347
Day 1
|
4.24 Liters per hour
Geometric Coefficient of Variation 20.8
|
4.38 Liters per hour
Geometric Coefficient of Variation 28.6
|
4.16 Liters per hour
Geometric Coefficient of Variation 28.7
|
4.98 Liters per hour
Geometric Coefficient of Variation 19.1
|
—
|
—
|
—
|
—
|
|
Part 2: Renal Clearance of Drug (CLr) After Repeat Dose Administration of GSK3882347
Day 7
|
4.34 Liters per hour
Geometric Coefficient of Variation 16.9
|
5.12 Liters per hour
Geometric Coefficient of Variation 19.8
|
4.22 Liters per hour
Geometric Coefficient of Variation 28.6
|
4.73 Liters per hour
Geometric Coefficient of Variation 18.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Single Dose Administration of GSK3882347
|
1181.6 Hours*nanogram per milliliter
Geometric Coefficient of Variation 20.3
|
4609.1 Hours*nanogram per milliliter
Geometric Coefficient of Variation 10.2
|
12519.7 Hours*nanogram per milliliter
Geometric Coefficient of Variation 19.7
|
20127.1 Hours*nanogram per milliliter
Geometric Coefficient of Variation 29.1
|
14009.0 Hours*nanogram per milliliter
Geometric Coefficient of Variation 10.1
|
33030.8 Hours*nanogram per milliliter
Geometric Coefficient of Variation 26.8
|
42353.5 Hours*nanogram per milliliter
Geometric Coefficient of Variation 26.6
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Plasma Concentrations at 12 Hours (C12) After Single Dose Administration of GSK3882347
|
58.73 Nanograms per milliliter
Geometric Coefficient of Variation 26.7
|
232.96 Nanograms per milliliter
Geometric Coefficient of Variation 17.1
|
636.41 Nanograms per milliliter
Geometric Coefficient of Variation 18.5
|
947.62 Nanograms per milliliter
Geometric Coefficient of Variation 27.5
|
857.73 Nanograms per milliliter
Geometric Coefficient of Variation 9.5
|
1806.50 Nanograms per milliliter
Geometric Coefficient of Variation 33.9
|
2714.12 Nanograms per milliliter
Geometric Coefficient of Variation 43.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Oral Clearance (CL/F) After Single Dose Administration of GSK3882347
|
6.92 Liters per hour
Geometric Coefficient of Variation 23.4
|
5.93 Liters per hour
Geometric Coefficient of Variation 18.1
|
6.69 Liters per hour
Geometric Coefficient of Variation 16.8
|
6.80 Liters per hour
Geometric Coefficient of Variation 26.5
|
8.53 Liters per hour
Geometric Coefficient of Variation 10.5
|
7.89 Liters per hour
Geometric Coefficient of Variation 26.1
|
10.06 Liters per hour
Geometric Coefficient of Variation 32.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Volume of Distribution After Oral Administration (Vz/F) After Single Dose Administration of GSK3882347
|
113.92 Liters
Geometric Coefficient of Variation 22.8
|
105.04 Liters
Geometric Coefficient of Variation 6.7
|
111.30 Liters
Geometric Coefficient of Variation 22.7
|
120.43 Liters
Geometric Coefficient of Variation 34.3
|
159.74 Liters
Geometric Coefficient of Variation 11.3
|
143.76 Liters
Geometric Coefficient of Variation 30.1
|
184.26 Liters
Geometric Coefficient of Variation 24.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Mean Residence Time (MRT) After Single Dose Administration of GSK3882347
|
15.775 Hours
Interval 12.76 to 23.46
|
16.843 Hours
Interval 12.45 to 19.61
|
15.614 Hours
Interval 13.38 to 19.62
|
16.262 Hours
Interval 14.36 to 19.84
|
18.818 Hours
Interval 16.57 to 20.73
|
17.259 Hours
Interval 15.41 to 19.89
|
18.630 Hours
Interval 15.32 to 22.9
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347
Day 1
|
4076.3 Hours*nanogram per milliliter
Geometric Coefficient of Variation 16.4
|
14411.9 Hours*nanogram per milliliter
Geometric Coefficient of Variation 28.9
|
30660.3 Hours*nanogram per milliliter
Geometric Coefficient of Variation 37.1
|
35231.6 Hours*nanogram per milliliter
Geometric Coefficient of Variation 26.3
|
—
|
—
|
—
|
—
|
|
Part 2: Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) After Repeat Dose Administration of GSK3882347
Day 7
|
4222.8 Hours*nanogram per milliliter
Geometric Coefficient of Variation 11.0
|
14506.3 Hours*nanogram per milliliter
Geometric Coefficient of Variation 28.9
|
41187.1 Hours*nanogram per milliliter
Geometric Coefficient of Variation 24.1
|
53121.9 Hours*nanogram per milliliter
Geometric Coefficient of Variation 23.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8 and 12 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347
Day 1
|
214.4 Nanograms per milliliter
Geometric Coefficient of Variation 23.5
|
709.1 Nanograms per milliliter
Geometric Coefficient of Variation 19.9
|
1704.8 Nanograms per milliliter
Geometric Coefficient of Variation 42.1
|
2068.2 Nanograms per milliliter
Geometric Coefficient of Variation 36.0
|
—
|
—
|
—
|
—
|
|
Part 2: Plasma Concentrations at 12 Hours (C12) After Repeat Dose Administration of GSK3882347
Day 7
|
221.5 Nanograms per milliliter
Geometric Coefficient of Variation 11.8
|
776.1 Nanograms per milliliter
Geometric Coefficient of Variation 28.3
|
2360.8 Nanograms per milliliter
Geometric Coefficient of Variation 30.6
|
3218.5 Nanograms per milliliter
Geometric Coefficient of Variation 21.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified data points were analyzed. The dose proportionality was assessed for doses administered under fasted conditions only. Being a FTIH study, the impact of food on drug PK was unknown; hence it would have been inaccurate to include fed arm in dose proportionality assessment in this FTIH study. Therefore, 250 mg fed arm was not considered in dose proportionality assessment
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% confidence interval (CI) for the slope are presented. The SD 250 mg fed treatment was not considered in the analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=19 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using AUC(0-infinity) After Single Dose Administration of GSK3882347 Under Fasted Condition
|
0.919 Slope of log dose
Interval 0.889 to 0.949
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dose in each treatment periodPopulation: PK Population. Only those participants with data available at the specified data points were analyzed. The dose proportionality was assessed for doses administered under fasted conditions only. Being a FTIH study, the impact of food on drug PK was unknown; hence it would have been inaccurate to include fed arm in dose proportionality assessment in this FTIH study. Therefore, 250 mg fed arm was not considered in dose proportionality assessment
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented. The SD 250 mg fed treatment was not considered in the analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=19 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Proportionality of GSK3882347 for Dose Levels 15 mg to 900 mg Using Cmax After Single Dose Administration of GSK3882347 Under Fasted Condition
|
0.903 Slope of log dose
Interval 0.865 to 0.941
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=32 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using AUC(0-tau) After Repeat Dose Administration of GSK3882347
Day 1
|
0.770 Slope of log dose
Interval 0.684 to 0.857
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using AUC(0-tau) After Repeat Dose Administration of GSK3882347
Day 7
|
0.908 Slope of log dose
Interval 0.841 to 0.976
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Dose proportionality was assessed using Power model. Log-e(dose) was fitted as fixed effect and participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used. Slope and 90% CI for the slope are presented.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=32 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using Cmax After Repeat Dose Administration of GSK3882347
Day 1
|
0.736 Slope of log dose
Interval 0.644 to 0.829
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Dose Proportionality of GSK3882347 for Dose Levels 50 mg to 900 mg Using Cmax After Repeat Dose Administration of GSK3882347
Day 7
|
0.841 Slope of log dose
Interval 0.763 to 0.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347. PK parameters were analyzed using standard non-compartmental analysis. Accumulation ratio was calculated as AUC(0-tau) at Day 7 divided by AUC(0-tau) at Day 1 for GSK3882347. Mixed effect model was used to assess accumulation ratio for the log transformed parameters. Treatment, day and the interaction of treatment and day were fitted as fixed effect. Participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Observed Accumulation Ratio (Ro) Using AUC(0-tau) After Repeat Dose Administration of GSK3882347
|
1.05 Ratio
Interval 0.93 to 1.18
|
1.05 Ratio
Interval 0.93 to 1.18
|
1.35 Ratio
Interval 1.2 to 1.52
|
1.53 Ratio
Interval 1.36 to 1.72
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 7: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24 hours post-dosePopulation: PK Population
Blood samples were collected at indicated time points for the analysis of time invariance. Time invariance was calculated as AUC(0-tau) at Day 7 divided by AUC(0-infinity) at Day 1 for GSK3882347. Mixed effect ANOVA model was used to assess time invariance for the log transformed parameters. Treatment, day and the interaction of treatment and day were fitted as fixed effect. Participant was fitted as random effect. Kenward and Roger method and unstructured covariance structure was used.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Time Invariance of GSK3882347
|
0.83 Ratio
Interval 0.74 to 0.94
|
0.87 Ratio
Interval 0.77 to 0.99
|
1.07 Ratio
Interval 0.95 to 1.2
|
1.13 Ratio
Interval 1.0 to 1.28
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 3, 4, 5, 6 and 7: Pre-dosePopulation: PK Population
Blood samples were collected at indicated time points for PK analysis of GSK3882347.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=8 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=8 Participants
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7
Day 3: Pre-dose
|
99.48 Nanograms per milliliter
Standard Deviation 19.360
|
326.89 Nanograms per milliliter
Standard Deviation 81.306
|
1157.589 Nanograms per milliliter
Standard Deviation 432.3864
|
1578.14 Nanograms per milliliter
Standard Deviation 328.085
|
—
|
—
|
—
|
—
|
|
Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7
Day 4: Pre-dose
|
96.66 Nanograms per milliliter
Standard Deviation 16.722
|
344.56 Nanograms per milliliter
Standard Deviation 112.891
|
1212.368 Nanograms per milliliter
Standard Deviation 438.9076
|
1883.90 Nanograms per milliliter
Standard Deviation 560.646
|
—
|
—
|
—
|
—
|
|
Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7
Day 5: Pre-dose
|
96.16 Nanograms per milliliter
Standard Deviation 15.683
|
329.37 Nanograms per milliliter
Standard Deviation 88.100
|
1166.770 Nanograms per milliliter
Standard Deviation 369.9656
|
1724.07 Nanograms per milliliter
Standard Deviation 524.054
|
—
|
—
|
—
|
—
|
|
Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7
Day 6: Pre-dose
|
97.50 Nanograms per milliliter
Standard Deviation 21.275
|
339.83 Nanograms per milliliter
Standard Deviation 100.604
|
1157.068 Nanograms per milliliter
Standard Deviation 384.6052
|
1776.54 Nanograms per milliliter
Standard Deviation 513.638
|
—
|
—
|
—
|
—
|
|
Part 2: Pre-dose Plasma Concentrations After Repeat Dose Administration of GSK3882347 From Days 3 to 7
Day 7: Pre-dose
|
92.46 Nanograms per milliliter
Standard Deviation 14.390
|
300.16 Nanograms per milliliter
Standard Deviation 75.925
|
1105.470 Nanograms per milliliter
Standard Deviation 464.5923
|
1769.40 Nanograms per milliliter
Standard Deviation 618.929
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
|
28472.2 Hours*nanogram per milliliter
Standard Error 0.08
|
21456.4 Hours*nanogram per milliliter
Standard Error 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC [0-t]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
|
36561.0 Hours*nanogram per milliliter
Standard Error 0.08
|
29091.9 Hours*nanogram per milliliter
Standard Error 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve Extrapolated From Time Zero to Infinity (AUC [0-infinity]) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
|
36768.0 Hours*nanogram per milliliter
Standard Error 0.08
|
29316.1 Hours*nanogram per milliliter
Standard Error 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Plasma Concentration (Cmax) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
|
3126.7 Nanograms per milliliter
Standard Error 0.10
|
1834.5 Nanograms per milliliter
Standard Error 0.10
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16 and 24 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Plasma Concentrations at 24 Hours (C24h) After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
|
494.7 Nanograms per milliliter
Standard Error 0.09
|
449.2 Nanograms per milliliter
Standard Error 0.09
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Tmax After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
|
4.000 Hours
Interval 2.0 to 6.0
|
4.000 Hours
Interval 2.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 15, 30 minutes, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 32, 48, 72 and 96 hours post-dosePopulation: PK Population.
Blood samples were collected at indicated time points for PK analysis of GSK3882347 250 mg under fasted and fed conditions for assessment of food effect. PK parameters were analyzed using standard non-compartmental analysis.
Outcome measures
| Measure |
Part 1: Single Dose Placebo
n=6 Participants
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 Participants
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Tlag After Single Dose Administration of GSK3882347 250 mg Under Fasted and Fed Conditions for Assessment of Food Effect
|
0.250 Hours
Interval 0.0 to 0.25
|
0.250 Hours
Interval 0.25 to 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1: Single Dose Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1: Single Dose GSK3882347 15 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: Single Dose GSK3882347 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Single Dose GSK3882347 150 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Single Dose GSK3882347 250 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: Single Dose GSK3882347 250 mg Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: Single Dose GSK3882347 500 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: Single Dose GSK3882347 900 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: Repeat Dose Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: Repeat Dose GSK3882347 50 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: Repeat Dose GSK3882347 150 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: Repeat Dose GSK3882347 500 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2: Repeat Dose GSK3882347 900 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Single Dose Placebo
n=14 participants at risk
Healthy participants in Part 1 received a SD of Placebo on Day 1 in either treatment Periods 1, 2, 3 and 4.
|
Part 1: Single Dose GSK3882347 15 mg
n=6 participants at risk
Healthy participants in Part 1 received a SD of GSK3882347 15 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 50 mg
n=6 participants at risk
Healthy participants in Part 1 received a SD of GSK3882347 50 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 150 mg
n=6 participants at risk
Healthy participants in Part 1 received a SD of GSK3882347 150 mg on Day 1 in treatment Period 2.
|
Part 1: Single Dose GSK3882347 250 mg
n=6 participants at risk
Healthy participants in Part 1 received a SD of GSK3882347 250 mg on Day 1 in treatment Period 3.
|
Part 1: Single Dose GSK3882347 250 mg Fed
n=6 participants at risk
Healthy participants in Part 1 received a SD of GSK3882347 250 mg under fed condition on Day 1 in treatment Period 4.
|
Part 1: Single Dose GSK3882347 500 mg
n=6 participants at risk
Healthy participants in Part 1 received a SD of GSK3882347 500 mg on Day 1 in treatment Period 1.
|
Part 1: Single Dose GSK3882347 900 mg
n=6 participants at risk
Healthy participants in Part 1 received a SD of GSK3882347 900 mg on Day 1 in treatment Period 2.
|
Part 2: Repeat Dose Placebo
n=8 participants at risk
Healthy participants in Part 2 received repeat dose (RD) of Placebo on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 50 mg
n=8 participants at risk
Healthy participants in Part 2 received RD of GSK3882347 50 mg on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 150 mg
n=8 participants at risk
Healthy participants in Part 2 received RD of GSK3882347 150 mg on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 500 mg
n=8 participants at risk
Healthy participants in Part 2 received RD of GSK3882347 500 mg on Days 1 to 7.
|
Part 2: Repeat Dose GSK3882347 900 mg
n=8 participants at risk
Healthy participants in Part 2 received RD of GSK3882347 900 mg on Days 1 to 7.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
1/14 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
2/14 • Number of events 3 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.1%
1/14 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Application site erythema
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Application site vesicles
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Catheter site pain
|
7.1%
1/14 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Swelling
|
7.1%
1/14 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.1%
1/14 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
25.0%
2/8 • Number of events 2 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Product use complaint
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
12.5%
1/8 • Number of events 1 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/8 • All-cause mortality, SAEs and Non-SAEs were collected from the start of study treatment up to 3 months for Part 1 and up to 26 days for Part 2
All-cause mortality, SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least one dose of study treatment.
|
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