Trial Outcomes & Findings for A Phase 1, First Time in Human (FTIH) Study to Evaluate GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Healthy Volunteers (NCT NCT03154086)
NCT ID: NCT03154086
Last Updated: 2019-08-09
Results Overview
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
Up to 64 days in Cohort 1
Results posted on
2019-08-09
Participant Flow
This was a two-part study. Part A was a single dose escalating and Part B was a repeat dose escalating. Participants participated in either Part A or Part B of the study. This was a single center study, conducted at one site in Australia.
A total number of 28 participants were enrolled in Part A and 40 participants were enrolled in Part B of the study. Participants in Part A, participated in one of the 3 Cohorts in Part A and Part B participants participated in one of the 5 Cohorts in Part B.
Participant milestones
| Measure |
Part A: Cohort 1: Placebo/GSK3352589 5mg/15mg/50mg
Participants received single oral dose of placebo tablet in Period 1 followed by GSK3352589 5 milligrams (mg) tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 1:GSK3352589 2mg/Placebo/GSK3352589 15mg/50mg
Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by Placebo tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 1: GSK3352589 2mg/ 5mg/Placebo/ GSK3352589 50mg
Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by Placebo tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 1:GSK3352589 2mg/5mg/15mg/Placebo
Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by Placebo tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 2:GSK3352589 25 mg Fasted/GSK3352589 25 mg Fed
Participants received single oral dose of GSK3352589 25 mg tablet in Period 1 (fasted state) and in Period 2 (fed state). Participants returned for their next scheduled dosing Period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A: Cohort 2: Placebo Fasted/Placebo Fed
Participants received single oral dose of placebo tablet matching GSK3352589 25 mg in Period 1 (fasted state) and in Period 2 (fed state). Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 3: GSK3352589 150 mg/Placebo
Participants received single oral dose of GSK3352589 150 mg tablet in Period 1 followed by placebo tablet matching GSK3352589 150 mg in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 3: Placebo /GSK3352589 400 mg
Participants received single oral dose of placebo tablet matching GSK3352589 400 mg in Period 1 followed by single oral dose of GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 3: GSK3352589 150 mg/GSK3352589 400 mg
Participants received single oral dose of GSK3352589 150 mg tablet in Period 1 followed by GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part B: Placebo BID
Participants received repeat oral doses of placebo BID (twice a day) tablet administered for 14 days in Part B of the study.
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Part B: GSK3352589 5 mg BID
Participants received repeat oral doses of GSK3352589 5 mg BID tablet administered for 14 days in Part B of the study.
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Part B: GSK3352589 15 mg BID
Participants received repeat oral doses of GSK3352589 15 mg BID tablet administered for 14 days in Part B of the study.
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Part B: GSK3352589 50 mg BID
Participants received repeat oral doses of GSK3352589 50 mg BID tablet administered for 14 days in Part B of the study.
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Part B: GSK3352589 100 mg BID
Participants received repeat doses of GSK3352589 100 mg BID administered for 14 days in Part B of the study.
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Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
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Part A: Cohort1 Period1 (Up to 3 Days)
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Part A: Cohort1 Period1 (Up to 3 Days)
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Part A: Cohort1 Washout1 (Up to 14 Days)
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Part A: Cohort1 Washout1 (Up to 14 Days)
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Part A: Cohort1 Washout1 (Up to 14 Days)
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Part A: Cohort1 Period2 (Up to 3 Days)
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Part A: Cohort1 Period2 (Up to 3 Days)
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PartA: Cohort1 Washout2 (Up to 14 Days)
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PartA: Cohort1 Washout2 (Up to 14 Days)
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Part A: Cohort1 Period3 (Up to 3 Days)
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Part A: Cohort1 Washout3 (Up to 14 Days)
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Part A: Cohort1 Washout3 (Up to 14 Days)
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Part A: Cohort1 Period4 (Up to 3 Days)
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Part A: Cohort1 Period4 (Up to 3 Days)
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Part A: Cohort2 Period1 (Up to 3 Days)
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Part A: Cohort2 Period1 (Up to 3 Days)
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Part A: Cohort2 Washout1 (Up to 14 Days)
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Part A: Cohort2 Washout1 (Up to 14 Days)
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Part A: Cohort2 Period2 (Up to 3 Days)
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Part A: Cohort2 Period2 (Up to 3 Days)
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Part A: Cohort3 Period1 (Up to 3 Days)
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Part A: Cohort3 Period1 (Up to 3 Days)
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Part A: Cohort3 Washout1 (Up to 14 Days)
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Part B (Up to 25 Days)
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Part B (Up to 25 Days)
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Reasons for withdrawal
| Measure |
Part A: Cohort 1: Placebo/GSK3352589 5mg/15mg/50mg
Participants received single oral dose of placebo tablet in Period 1 followed by GSK3352589 5 milligrams (mg) tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 1:GSK3352589 2mg/Placebo/GSK3352589 15mg/50mg
Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by Placebo tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 1: GSK3352589 2mg/ 5mg/Placebo/ GSK3352589 50mg
Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by Placebo tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 1:GSK3352589 2mg/5mg/15mg/Placebo
Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by Placebo tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 2:GSK3352589 25 mg Fasted/GSK3352589 25 mg Fed
Participants received single oral dose of GSK3352589 25 mg tablet in Period 1 (fasted state) and in Period 2 (fed state). Participants returned for their next scheduled dosing Period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A: Cohort 2: Placebo Fasted/Placebo Fed
Participants received single oral dose of placebo tablet matching GSK3352589 25 mg in Period 1 (fasted state) and in Period 2 (fed state). Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 3: GSK3352589 150 mg/Placebo
Participants received single oral dose of GSK3352589 150 mg tablet in Period 1 followed by placebo tablet matching GSK3352589 150 mg in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 3: Placebo /GSK3352589 400 mg
Participants received single oral dose of placebo tablet matching GSK3352589 400 mg in Period 1 followed by single oral dose of GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part A:Cohort 3: GSK3352589 150 mg/GSK3352589 400 mg
Participants received single oral dose of GSK3352589 150 mg tablet in Period 1 followed by GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
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Part B: Placebo BID
Participants received repeat oral doses of placebo BID (twice a day) tablet administered for 14 days in Part B of the study.
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Part B: GSK3352589 5 mg BID
Participants received repeat oral doses of GSK3352589 5 mg BID tablet administered for 14 days in Part B of the study.
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Part B: GSK3352589 15 mg BID
Participants received repeat oral doses of GSK3352589 15 mg BID tablet administered for 14 days in Part B of the study.
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Part B: GSK3352589 50 mg BID
Participants received repeat oral doses of GSK3352589 50 mg BID tablet administered for 14 days in Part B of the study.
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Part B: GSK3352589 100 mg BID
Participants received repeat doses of GSK3352589 100 mg BID administered for 14 days in Part B of the study.
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Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
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Part A: Cohort1 Washout1 (Up to 14 Days)
Protocol Violation
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PartA: Cohort1 Washout2 (Up to 14 Days)
Adverse Event
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Part A: Cohort1 Washout3 (Up to 14 Days)
Adverse Event
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Part A: Cohort1 Period4 (Up to 3 Days)
Protocol Violation
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|
0
|
0
|
0
|
0
|
|
Part A: Cohort3 Period2 (Up to 3 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A: Cohort3 Period2 (Up to 3 Days)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B (Up to 25 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 1, First Time in Human (FTIH) Study to Evaluate GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Part A: Cohort 1: Placebo/GSK3352589 5mg/15mg/50mg
n=3 Participants
Participants received single oral dose of placebo tablet in Period 1 followed by GSK3352589 5 milligrams (mg) tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
|
Part A:Cohort 1:GSK3352589 2mg/Placebo/GSK3352589 15mg/50mg
n=3 Participants
Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by Placebo tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
|
Part A:Cohort 1: GSK3352589 2mg/ 5mg/Placebo/ GSK3352589 50mg
n=2 Participants
Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by Placebo tablet in Period 3 followed by GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
|
Part A:Cohort 1:GSK3352589 2mg/5mg/15mg/Placebo
n=3 Participants
Participants received single oral dose of GSK3352589 2 mg tablet in Period 1 followed by GSK3352589 5 mg tablet in Period 2 followed by GSK3352589 15 mg tablet in Period 3 followed by Placebo tablet in Period 4 of Cohort 1 in Part A of the study. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
|
Part A:Cohort 2:GSK3352589 25 mg Fasted/GSK3352589 25 mg Fed
n=6 Participants
Participants received single oral dose of GSK3352589 25 mg tablet in Period 1 (fasted state) and in Period 2 (fed state). Participants returned for their next scheduled dosing Period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
|
Part A: Cohort 2: Placebo Fasted/Placebo Fed
n=2 Participants
Participants received single oral dose of placebo tablet matching GSK3352589 25 mg in Period 1 (fasted state) and in Period 2 (fed state). Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
|
Part A:Cohort 3: GSK3352589 150 mg/Placebo
n=2 Participants
Participants received single oral dose of GSK3352589 150 mg tablet in Period 1 followed by placebo tablet matching GSK3352589 150 mg in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
|
Part A:Cohort 3: Placebo /GSK3352589 400 mg
n=2 Participants
Participants received single oral dose of placebo tablet matching GSK3352589 400 mg in Period 1 followed by single oral dose of GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
|
Part A:Cohort 3: GSK3352589 150 mg/GSK3352589 400 mg
n=5 Participants
Participants received single oral dose of GSK3352589 150 mg tablet in Period 1 followed by GSK3352589 400 mg tablet in Period 2 in Cohort 3 of Part A. Participants returned for their next scheduled dosing period approximately 14 days (wash out period) after administration of the study drug during the prior dosing period.
|
Part B: Placebo BID
n=10 Participants
Participants received repeat oral doses of placebo BID (twice a day) tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 5 mg BID
n=6 Participants
Participants received repeat oral doses of GSK3352589 5 mg BID tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 15 mg BID
n=6 Participants
Participants received repeat oral doses of GSK3352589 15 mg BID tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 50 mg BID
n=6 Participants
Participants received repeat oral doses of GSK3352589 50 mg BID tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 100 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 100 mg BID administered for 14 days in Part B of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.0 Years
STANDARD_DEVIATION 14.00 • n=5 Participants
|
26.7 Years
STANDARD_DEVIATION 4.73 • n=7 Participants
|
33.5 Years
STANDARD_DEVIATION 9.19 • n=5 Participants
|
41.0 Years
STANDARD_DEVIATION 5.20 • n=4 Participants
|
29.7 Years
STANDARD_DEVIATION 8.57 • n=21 Participants
|
34.5 Years
STANDARD_DEVIATION 3.54 • n=10 Participants
|
40.5 Years
STANDARD_DEVIATION 7.78 • n=115 Participants
|
44.5 Years
STANDARD_DEVIATION 0.71 • n=24 Participants
|
28.8 Years
STANDARD_DEVIATION 7.43 • n=42 Participants
|
25.5 Years
STANDARD_DEVIATION 5.40 • n=42 Participants
|
30.8 Years
STANDARD_DEVIATION 8.11 • n=42 Participants
|
33.3 Years
STANDARD_DEVIATION 8.45 • n=42 Participants
|
23.3 Years
STANDARD_DEVIATION 2.88 • n=36 Participants
|
23.7 Years
STANDARD_DEVIATION 4.59 • n=36 Participants
|
32.2 Years
STANDARD_DEVIATION 11.20 • n=24 Participants
|
30.5 Years
STANDARD_DEVIATION 8.95 • n=135 Participants
|
|
Sex: Female, Male
Female
|
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=10 Participants
|
0 Participants
n=115 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
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
66 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Native-Asian
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
10 Participants
n=135 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
55 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
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=10 Participants
|
0 Participants
n=115 Participants
|
1 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
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: Up to 64 days in Cohort 1Population: Safety Population comprised of all randomized participants who received at least one dose of study medication and was based on the actual treatment received, if this differed from that to which the participant was randomized.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=8 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs in Cohort 1
Any SAE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part A: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs in Cohort 1
Any non-SAE
|
3 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days in Cohort 2Population: Safety population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With SAEs and Non-SAEs in Cohort 2
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With SAEs and Non-SAEs in Cohort 2
Any non-SAE
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days in Cohort 3Population: Safety population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=4 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=5 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With SAEs and Non-SAEs in Cohort 3
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With SAEs and Non-SAEs in Cohort 3
Any non-SAE
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 25 daysPopulation: Safety population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With SAEs and Non-SAEs
Any non-SAE
|
9 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Part B: Number of Participants With SAEs and Non-SAEs
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 64 days in Cohort 1Population: Safety population
A complete physical examination will include, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=8 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days in Cohort 2Population: Safety population
A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days in Cohort 3Population: Safety population
A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=4 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=5 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 3
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 25 daysPopulation: Safety population
A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Abnormal Findings After Physical Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Triplicate 12-lead ECGs were obtained at indicated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline is defined as the last available, non-missing mean value of triplicate assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). The number of participants with abnormal clinically significant (CS) and not clinically significant (NCS) findings for ECG parameters have been presented.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Baseline (Day 1; Pre-dose); Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Baseline (Day 1; Pre-dose); Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Day 1; 12 Hours Post-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Day 2; Abnormal NCS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Day 2; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Day 1; 1 Hour Post-dose; Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Day 1; 1 Hour Post-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Day 1; 4 Hours Post-dose; Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Day 1; 4 Hours Post-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3
Day 1; 12 Hours Post-dose; Abnormal NCS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2Population: Safety population
Triplicate 12-lead ECGs were obtained at indicated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline is defined as the last available, non-missing mean value of triplicate assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). The number of participants with abnormal CS and NCS findings for ECG parameters have been presented.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Baseline (Day 1; Pre-dose); Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Baseline; (Day 1;pre dose); Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Day 1; 4 Hours Post-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Day 1; 1 Hour Post-dose; Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Day 1; 1 Hour Post-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Day 1; 4 Hours Post-dose; Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Day 1; 12 Hours Post-dose; Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Day 1; 12 Hours Post-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Day 2; Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal ECG Findings in Cohort 2
Day 2; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 7 (Pre-dose, 4 Hours Post-dose), Day 14 (Pre-dose, 4 Hours Post-dose), Follow-up (Day 25)Population: Safety population
Triplicate 12-lead ECGs were obtained at indicated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline is defined as the last available, non-missing mean value of triplicate assessment prior to the first administration of study drug. The number of participants with abnormal CS and NCS findings for ECG parameters have been presented.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Abnormal ECG Findings
Day 7; Pre-dose; Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Day 14; 4 Hours Post-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Follow-up (Day 25); Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Day 1; 4 Hours Post-dose; Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Day 1; 4 Hours Post-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Day 7; Pre-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Day 7; 4 Hours Post-dose; Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Day 7; 4 Hours Post-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Day 14; Pre-dose; Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Day 14; Pre-dose; Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Day 14; 4 Hours Post-dose; Abnormal NCS
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Follow-up (Day 25); Abnormal NCS
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Baseline (Day 1; Pre-dose); Abnormal NCS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal ECG Findings
Baseline (Day 1; Pre-dose); Abnormal CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood pressure of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
SBP; Day 2
|
-2.42 Millimeters of mercury
Standard Deviation 10.00
|
-4.50 Millimeters of mercury
Standard Deviation 5.74
|
-1.42 Millimeters of mercury
Standard Deviation 9.77
|
-2.17 Millimeters of mercury
Standard Deviation 10.87
|
-3.40 Millimeters of mercury
Standard Deviation 7.54
|
1.50 Millimeters of mercury
Standard Deviation 2.53
|
-5.00 Millimeters of mercury
Standard Deviation 5.78
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
SBP; Day 3
|
-3.63 Millimeters of mercury
Standard Deviation 11.05
|
-8.67 Millimeters of mercury
Standard Deviation 5.12
|
-0.42 Millimeters of mercury
Standard Deviation 16.59
|
1.92 Millimeters of mercury
Standard Deviation 7.05
|
-3.30 Millimeters of mercury
Standard Deviation 10.12
|
0.67 Millimeters of mercury
Standard Deviation 4.17
|
0.60 Millimeters of mercury
Standard Deviation 5.90
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
DBP; Day 1; 4 Hours Post dose
|
2.04 Millimeters of mercury
Standard Deviation 5.87
|
-0.42 Millimeters of mercury
Standard Deviation 5.33
|
-1.83 Millimeters of mercury
Standard Deviation 5.39
|
2.25 Millimeters of mercury
Standard Deviation 9.95
|
-2.10 Millimeters of mercury
Standard Deviation 6.07
|
1.17 Millimeters of mercury
Standard Deviation 4.77
|
6.50 Millimeters of mercury
Standard Deviation 2.06
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
SBP; Day 1; 4 Hours Post dose
|
-1.29 Millimeters of mercury
Standard Deviation 11.32
|
-5.83 Millimeters of mercury
Standard Deviation 5.86
|
-1.33 Millimeters of mercury
Standard Deviation 13.56
|
3.75 Millimeters of mercury
Standard Deviation 11.04
|
-3.60 Millimeters of mercury
Standard Deviation 14.72
|
-1.75 Millimeters of mercury
Standard Deviation 3.27
|
1.40 Millimeters of mercury
Standard Deviation 1.29
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
SBP; Day 1; 1 Hour Post dose
|
-1.25 Millimeters of mercury
Standard Deviation 9.61
|
-1.75 Millimeters of mercury
Standard Deviation 4.71
|
-2.08 Millimeters of mercury
Standard Deviation 11.72
|
3.00 Millimeters of mercury
Standard Deviation 9.72
|
-2.70 Millimeters of mercury
Standard Deviation 12.26
|
1.58 Millimeters of mercury
Standard Deviation 5.55
|
-0.10 Millimeters of mercury
Standard Deviation 3.45
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
SBP; Day 1; 12 Hours Post dose
|
2.21 Millimeters of mercury
Standard Deviation 8.65
|
-3.83 Millimeters of mercury
Standard Deviation 10.11
|
1.08 Millimeters of mercury
Standard Deviation 11.33
|
3.00 Millimeters of mercury
Standard Deviation 10.39
|
3.10 Millimeters of mercury
Standard Deviation 9.15
|
1.33 Millimeters of mercury
Standard Deviation 4.07
|
3.90 Millimeters of mercury
Standard Deviation 6.69
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
DBP; Day 1; 1 Hour Post dose
|
-0.54 Millimeters of mercury
Standard Deviation 5.62
|
-0.67 Millimeters of mercury
Standard Deviation 3.89
|
1.75 Millimeters of mercury
Standard Deviation 4.71
|
1.08 Millimeters of mercury
Standard Deviation 7.34
|
1.00 Millimeters of mercury
Standard Deviation 10.31
|
0.33 Millimeters of mercury
Standard Deviation 4.01
|
4.20 Millimeters of mercury
Standard Deviation 2.59
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
DBP; Day 1; 12 Hours Post dose
|
-2.92 Millimeters of mercury
Standard Deviation 5.67
|
-4.42 Millimeters of mercury
Standard Deviation 6.58
|
-3.08 Millimeters of mercury
Standard Deviation 5.29
|
-5.75 Millimeters of mercury
Standard Deviation 5.33
|
-4.10 Millimeters of mercury
Standard Deviation 8.13
|
-1.08 Millimeters of mercury
Standard Deviation 5.30
|
0.40 Millimeters of mercury
Standard Deviation 7.99
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
DBP; Day 2
|
-2.13 Millimeters of mercury
Standard Deviation 4.71
|
-2.58 Millimeters of mercury
Standard Deviation 7.91
|
-2.25 Millimeters of mercury
Standard Deviation 4.10
|
-1.17 Millimeters of mercury
Standard Deviation 4.01
|
-5.40 Millimeters of mercury
Standard Deviation 3.44
|
-0.17 Millimeters of mercury
Standard Deviation 5.34
|
3.60 Millimeters of mercury
Standard Deviation 4.92
|
—
|
|
Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3
DBP; Day 3
|
1.13 Millimeters of mercury
Standard Deviation 6.30
|
-2.67 Millimeters of mercury
Standard Deviation 7.72
|
2.67 Millimeters of mercury
Standard Deviation 5.65
|
-1.50 Millimeters of mercury
Standard Deviation 6.43
|
-2.20 Millimeters of mercury
Standard Deviation 4.27
|
0.75 Millimeters of mercury
Standard Deviation 4.97
|
3.80 Millimeters of mercury
Standard Deviation 4.91
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3Population: Safety population
Blood pressure of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in SBP and DBP in Cohort 2
SBP; Day 1; 1 Hour Post dose
|
3.75 Millimeters of mercury
Standard Deviation 3.89
|
6.00 Millimeters of mercury
Standard Deviation 8.49
|
3.75 Millimeters of mercury
Standard Deviation 9.68
|
-6.58 Millimeters of mercury
Standard Deviation 9.91
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in SBP and DBP in Cohort 2
SBP; Day 1; 4 Hours Post dose
|
-1.75 Millimeters of mercury
Standard Deviation 1.06
|
-6.50 Millimeters of mercury
Standard Deviation 9.19
|
-5.17 Millimeters of mercury
Standard Deviation 11.44
|
-6.25 Millimeters of mercury
Standard Deviation 10.30
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in SBP and DBP in Cohort 2
SBP; Day 1; 12 Hours Post dose
|
1.75 Millimeters of mercury
Standard Deviation 9.55
|
10.75 Millimeters of mercury
Standard Deviation 15.91
|
1.50 Millimeters of mercury
Standard Deviation 10.84
|
1.50 Millimeters of mercury
Standard Deviation 11.66
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in SBP and DBP in Cohort 2
SBP; Day 2
|
-6.75 Millimeters of mercury
Standard Deviation 5.30
|
-3.75 Millimeters of mercury
Standard Deviation 4.60
|
-7.58 Millimeters of mercury
Standard Deviation 5.18
|
-5.00 Millimeters of mercury
Standard Deviation 9.77
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in SBP and DBP in Cohort 2
SBP; Day 3
|
-0.25 Millimeters of mercury
Standard Deviation 0.35
|
6.75 Millimeters of mercury
Standard Deviation 10.96
|
-4.50 Millimeters of mercury
Standard Deviation 8.06
|
1.00 Millimeters of mercury
Standard Deviation 7.54
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in SBP and DBP in Cohort 2
DBP; Day 1; 1 Hour Post dose
|
1.25 Millimeters of mercury
Standard Deviation 3.89
|
-5.75 Millimeters of mercury
Standard Deviation 2.47
|
1.67 Millimeters of mercury
Standard Deviation 6.23
|
-4.25 Millimeters of mercury
Standard Deviation 5.67
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in SBP and DBP in Cohort 2
DBP; Day 1; 4 Hours Post dose
|
-3.25 Millimeters of mercury
Standard Deviation 3.18
|
-5.00 Millimeters of mercury
Standard Deviation 3.54
|
-1.67 Millimeters of mercury
Standard Deviation 7.10
|
-4.75 Millimeters of mercury
Standard Deviation 5.99
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in SBP and DBP in Cohort 2
DBP; Day 1; 12 Hours Post dose
|
-5.25 Millimeters of mercury
Standard Deviation 2.47
|
-3.00 Millimeters of mercury
Standard Deviation 2.83
|
-2.67 Millimeters of mercury
Standard Deviation 6.92
|
-6.00 Millimeters of mercury
Standard Deviation 6.87
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in SBP and DBP in Cohort 2
DBP; Day 2
|
-3.50 Millimeters of mercury
Standard Deviation 2.12
|
-5.25 Millimeters of mercury
Standard Deviation 6.72
|
-1.92 Millimeters of mercury
Standard Deviation 4.41
|
-2.75 Millimeters of mercury
Standard Deviation 3.49
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in SBP and DBP in Cohort 2
DBP; Day 3
|
1.50 Millimeters of mercury
Standard Deviation 8.49
|
0.75 Millimeters of mercury
Standard Deviation 7.42
|
3.58 Millimeters of mercury
Standard Deviation 6.94
|
2.08 Millimeters of mercury
Standard Deviation 5.01
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Blood pressure of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 9; n=10,6,6,6,6,6
|
-10.00 Millimeters of mercury
Standard Deviation 8.36
|
-1.08 Millimeters of mercury
Standard Deviation 8.67
|
-3.08 Millimeters of mercury
Standard Deviation 4.19
|
-8.00 Millimeters of mercury
Standard Deviation 9.17
|
-6.75 Millimeters of mercury
Standard Deviation 7.13
|
-4.42 Millimeters of mercury
Standard Deviation 6.73
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 15; n=10,5,6,6,6,6
|
-6.05 Millimeters of mercury
Standard Deviation 10.20
|
-1.00 Millimeters of mercury
Standard Deviation 6.78
|
8.08 Millimeters of mercury
Standard Deviation 8.11
|
-5.92 Millimeters of mercury
Standard Deviation 14.17
|
2.67 Millimeters of mercury
Standard Deviation 13.53
|
-5.42 Millimeters of mercury
Standard Deviation 8.46
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 1; 4 Hours Post dose; n=10,6,6,6,6,6
|
-4.70 Millimeters of mercury
Standard Deviation 7.00
|
-1.83 Millimeters of mercury
Standard Deviation 6.59
|
-2.33 Millimeters of mercury
Standard Deviation 6.01
|
1.17 Millimeters of mercury
Standard Deviation 10.69
|
-2.33 Millimeters of mercury
Standard Deviation 11.79
|
-8.08 Millimeters of mercury
Standard Deviation 7.39
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 2; n=10,6,6,6,6,6
|
-7.35 Millimeters of mercury
Standard Deviation 5.61
|
-6.25 Millimeters of mercury
Standard Deviation 5.37
|
-5.75 Millimeters of mercury
Standard Deviation 7.37
|
-2.33 Millimeters of mercury
Standard Deviation 13.01
|
-4.08 Millimeters of mercury
Standard Deviation 12.69
|
-9.42 Millimeters of mercury
Standard Deviation 11.58
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 3; n=10,6,6,6,6,6
|
-5.90 Millimeters of mercury
Standard Deviation 6.50
|
-5.25 Millimeters of mercury
Standard Deviation 13.97
|
-1.42 Millimeters of mercury
Standard Deviation 6.42
|
-9.83 Millimeters of mercury
Standard Deviation 18.11
|
-6.83 Millimeters of mercury
Standard Deviation 11.57
|
-5.58 Millimeters of mercury
Standard Deviation 5.24
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 4; n=10,6,6,6,6,6
|
-7.75 Millimeters of mercury
Standard Deviation 6.91
|
-5.83 Millimeters of mercury
Standard Deviation 9.23
|
0.83 Millimeters of mercury
Standard Deviation 8.88
|
-0.08 Millimeters of mercury
Standard Deviation 15.46
|
-9.08 Millimeters of mercury
Standard Deviation 11.13
|
-9.42 Millimeters of mercury
Standard Deviation 6.26
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 5; n=10,6,6,6,6,6
|
-8.55 Millimeters of mercury
Standard Deviation 8.39
|
-7.00 Millimeters of mercury
Standard Deviation 5.85
|
-1.08 Millimeters of mercury
Standard Deviation 5.39
|
-9.33 Millimeters of mercury
Standard Deviation 18.90
|
-3.92 Millimeters of mercury
Standard Deviation 14.39
|
-11.17 Millimeters of mercury
Standard Deviation 8.52
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 6; n=10,6,6,6,6,6
|
-9.65 Millimeters of mercury
Standard Deviation 6.93
|
-5.33 Millimeters of mercury
Standard Deviation 8.52
|
-5.42 Millimeters of mercury
Standard Deviation 4.25
|
-6.50 Millimeters of mercury
Standard Deviation 13.10
|
-4.08 Millimeters of mercury
Standard Deviation 16.53
|
-10.33 Millimeters of mercury
Standard Deviation 15.03
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 7, Pre-dose; n=10,6,6,6,6,6
|
-7.25 Millimeters of mercury
Standard Deviation 8.36
|
-9.75 Millimeters of mercury
Standard Deviation 6.57
|
-7.83 Millimeters of mercury
Standard Deviation 5.85
|
-7.83 Millimeters of mercury
Standard Deviation 14.75
|
-3.50 Millimeters of mercury
Standard Deviation 10.48
|
-3.92 Millimeters of mercury
Standard Deviation 13.91
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 7, 4 Hours Post-dose; n=10,6,6,6,6,6
|
-9.00 Millimeters of mercury
Standard Deviation 5.61
|
-6.92 Millimeters of mercury
Standard Deviation 6.50
|
-6.67 Millimeters of mercury
Standard Deviation 7.93
|
-6.92 Millimeters of mercury
Standard Deviation 10.58
|
-5.92 Millimeters of mercury
Standard Deviation 15.81
|
-7.50 Millimeters of mercury
Standard Deviation 14.55
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 8; n=10,6,6,6,6,6
|
-8.95 Millimeters of mercury
Standard Deviation 5.71
|
-6.00 Millimeters of mercury
Standard Deviation 9.87
|
-7.67 Millimeters of mercury
Standard Deviation 14.50
|
-4.50 Millimeters of mercury
Standard Deviation 10.31
|
-8.00 Millimeters of mercury
Standard Deviation 9.98
|
-4.75 Millimeters of mercury
Standard Deviation 10.01
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 9; n=10,6,6,6,6,6
|
-11.90 Millimeters of mercury
Standard Deviation 9.74
|
0.67 Millimeters of mercury
Standard Deviation 11.89
|
-5.83 Millimeters of mercury
Standard Deviation 5.19
|
-11.08 Millimeters of mercury
Standard Deviation 15.23
|
-8.33 Millimeters of mercury
Standard Deviation 11.99
|
-9.00 Millimeters of mercury
Standard Deviation 13.70
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 10; n=10,6,6,6,6,6
|
-7.15 Millimeters of mercury
Standard Deviation 7.34
|
-5.67 Millimeters of mercury
Standard Deviation 7.15
|
-1.67 Millimeters of mercury
Standard Deviation 6.25
|
-7.67 Millimeters of mercury
Standard Deviation 15.08
|
-9.50 Millimeters of mercury
Standard Deviation 13.57
|
-15.67 Millimeters of mercury
Standard Deviation 18.97
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 11; n=10,6,6,6,6,6
|
-8.60 Millimeters of mercury
Standard Deviation 8.03
|
-5.00 Millimeters of mercury
Standard Deviation 9.42
|
-3.83 Millimeters of mercury
Standard Deviation 14.31
|
-7.25 Millimeters of mercury
Standard Deviation 16.23
|
-8.42 Millimeters of mercury
Standard Deviation 10.95
|
-9.50 Millimeters of mercury
Standard Deviation 10.31
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 12; n=10,6,6,6,6,6
|
-8.50 Millimeters of mercury
Standard Deviation 9.06
|
-5.58 Millimeters of mercury
Standard Deviation 10.74
|
-0.08 Millimeters of mercury
Standard Deviation 10.03
|
-4.00 Millimeters of mercury
Standard Deviation 18.10
|
-9.33 Millimeters of mercury
Standard Deviation 13.52
|
-4.25 Millimeters of mercury
Standard Deviation 12.50
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 13; n=10,6,6,6,6,6
|
-9.15 Millimeters of mercury
Standard Deviation 7.63
|
-5.33 Millimeters of mercury
Standard Deviation 10.30
|
-1.58 Millimeters of mercury
Standard Deviation 6.96
|
-6.67 Millimeters of mercury
Standard Deviation 17.26
|
-8.08 Millimeters of mercury
Standard Deviation 16.69
|
-6.58 Millimeters of mercury
Standard Deviation 9.84
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 14, Pre-dose; n=10,6,6,6,6,6
|
-6.90 Millimeters of mercury
Standard Deviation 9.73
|
-5.42 Millimeters of mercury
Standard Deviation 7.64
|
-0.25 Millimeters of mercury
Standard Deviation 3.76
|
-1.83 Millimeters of mercury
Standard Deviation 15.28
|
0.83 Millimeters of mercury
Standard Deviation 10.93
|
-9.50 Millimeters of mercury
Standard Deviation 6.98
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Day 14, 4 Hours Post-dose; n=10,5,6,6,6,6
|
-5.15 Millimeters of mercury
Standard Deviation 9.48
|
-8.50 Millimeters of mercury
Standard Deviation 8.12
|
0.50 Millimeters of mercury
Standard Deviation 7.13
|
-13.00 Millimeters of mercury
Standard Deviation 13.90
|
-0.25 Millimeters of mercury
Standard Deviation 13.15
|
-5.67 Millimeters of mercury
Standard Deviation 8.64
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
SBP; Follow-up (Day 25); n=10,6,6,6,6,6
|
-6.85 Millimeters of mercury
Standard Deviation 9.32
|
-4.42 Millimeters of mercury
Standard Deviation 11.63
|
-3.67 Millimeters of mercury
Standard Deviation 7.74
|
0.08 Millimeters of mercury
Standard Deviation 11.00
|
-1.08 Millimeters of mercury
Standard Deviation 12.64
|
-2.83 Millimeters of mercury
Standard Deviation 7.81
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 1; 4 Hours Post dose; n=10,6,6,6,6,6
|
-4.90 Millimeters of mercury
Standard Deviation 5.78
|
-2.17 Millimeters of mercury
Standard Deviation 5.27
|
-1.42 Millimeters of mercury
Standard Deviation 6.92
|
-2.08 Millimeters of mercury
Standard Deviation 5.56
|
-5.00 Millimeters of mercury
Standard Deviation 7.06
|
-3.33 Millimeters of mercury
Standard Deviation 6.77
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 2; n=10,6,6,6,6,6
|
-6.05 Millimeters of mercury
Standard Deviation 4.83
|
1.50 Millimeters of mercury
Standard Deviation 9.84
|
-1.67 Millimeters of mercury
Standard Deviation 5.60
|
-3.67 Millimeters of mercury
Standard Deviation 8.22
|
-3.17 Millimeters of mercury
Standard Deviation 7.47
|
-2.25 Millimeters of mercury
Standard Deviation 8.85
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 3; n=10,6,6,6,6,6
|
-3.30 Millimeters of mercury
Standard Deviation 5.30
|
0.08 Millimeters of mercury
Standard Deviation 6.64
|
-2.75 Millimeters of mercury
Standard Deviation 4.91
|
-3.50 Millimeters of mercury
Standard Deviation 6.19
|
-5.00 Millimeters of mercury
Standard Deviation 6.54
|
-2.17 Millimeters of mercury
Standard Deviation 7.16
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 4; n=10,6,6,6,6,6
|
-7.05 Millimeters of mercury
Standard Deviation 6.89
|
-0.58 Millimeters of mercury
Standard Deviation 10.28
|
-1.33 Millimeters of mercury
Standard Deviation 4.54
|
-3.00 Millimeters of mercury
Standard Deviation 5.93
|
-3.33 Millimeters of mercury
Standard Deviation 2.82
|
-3.67 Millimeters of mercury
Standard Deviation 6.68
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 5; n=10,6,6,6,6,6
|
-7.80 Millimeters of mercury
Standard Deviation 9.26
|
-1.67 Millimeters of mercury
Standard Deviation 5.67
|
-4.17 Millimeters of mercury
Standard Deviation 3.92
|
-8.25 Millimeters of mercury
Standard Deviation 7.90
|
-3.58 Millimeters of mercury
Standard Deviation 6.44
|
-3.33 Millimeters of mercury
Standard Deviation 9.36
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 6; n=10,6,6,6,6,6
|
-10.20 Millimeters of mercury
Standard Deviation 7.37
|
-1.67 Millimeters of mercury
Standard Deviation 4.83
|
-3.25 Millimeters of mercury
Standard Deviation 6.02
|
-7.25 Millimeters of mercury
Standard Deviation 5.82
|
-3.00 Millimeters of mercury
Standard Deviation 7.54
|
-6.67 Millimeters of mercury
Standard Deviation 7.94
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 7, Pre-dose; n=10,6,6,6,6,6
|
-7.20 Millimeters of mercury
Standard Deviation 7.52
|
-4.17 Millimeters of mercury
Standard Deviation 4.67
|
-6.75 Millimeters of mercury
Standard Deviation 7.76
|
-5.17 Millimeters of mercury
Standard Deviation 5.83
|
4.58 Millimeters of mercury
Standard Deviation 3.99
|
0.33 Millimeters of mercury
Standard Deviation 8.68
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 7, 4 Hours Post-dose; n=10,6,6,6,6,6
|
-8.65 Millimeters of mercury
Standard Deviation 7.04
|
-3.75 Millimeters of mercury
Standard Deviation 4.12
|
-5.92 Millimeters of mercury
Standard Deviation 4.62
|
-6.83 Millimeters of mercury
Standard Deviation 6.12
|
-2.75 Millimeters of mercury
Standard Deviation 7.06
|
-3.67 Millimeters of mercury
Standard Deviation 10.24
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 8; n=10,6,6,6,6,6
|
-8.20 Millimeters of mercury
Standard Deviation 6.86
|
-1.75 Millimeters of mercury
Standard Deviation 9.42
|
-5.50 Millimeters of mercury
Standard Deviation 9.49
|
-2.75 Millimeters of mercury
Standard Deviation 8.93
|
-1.25 Millimeters of mercury
Standard Deviation 4.47
|
-4.42 Millimeters of mercury
Standard Deviation 7.49
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 10; n=10,6,6,6,6,6
|
-5.35 Millimeters of mercury
Standard Deviation 8.93
|
1.50 Millimeters of mercury
Standard Deviation 4.71
|
-3.00 Millimeters of mercury
Standard Deviation 7.22
|
-5.25 Millimeters of mercury
Standard Deviation 6.26
|
-2.42 Millimeters of mercury
Standard Deviation 8.75
|
-6.50 Millimeters of mercury
Standard Deviation 12.08
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 11; n=10,6,6,6,6,6
|
-6.80 Millimeters of mercury
Standard Deviation 10.14
|
-1.25 Millimeters of mercury
Standard Deviation 8.60
|
-4.58 Millimeters of mercury
Standard Deviation 7.37
|
-6.25 Millimeters of mercury
Standard Deviation 7.01
|
-5.08 Millimeters of mercury
Standard Deviation 4.73
|
-3.92 Millimeters of mercury
Standard Deviation 7.21
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 12; n=10,6,6,6,6,6
|
-6.95 Millimeters of mercury
Standard Deviation 5.44
|
-2.67 Millimeters of mercury
Standard Deviation 8.65
|
-1.42 Millimeters of mercury
Standard Deviation 4.44
|
-5.42 Millimeters of mercury
Standard Deviation 7.81
|
-2.00 Millimeters of mercury
Standard Deviation 3.79
|
-0.50 Millimeters of mercury
Standard Deviation 7.62
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 13; n=10,6,6,6,6,6
|
-7.55 Millimeters of mercury
Standard Deviation 8.26
|
-1.42 Millimeters of mercury
Standard Deviation 10.70
|
-2.50 Millimeters of mercury
Standard Deviation 5.13
|
-2.92 Millimeters of mercury
Standard Deviation 8.23
|
-1.08 Millimeters of mercury
Standard Deviation 5.70
|
-2.67 Millimeters of mercury
Standard Deviation 8.17
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 14, Pre-dose; n=10,6,6,6,6,6
|
-6.10 Millimeters of mercury
Standard Deviation 7.05
|
-4.25 Millimeters of mercury
Standard Deviation 6.19
|
0.17 Millimeters of mercury
Standard Deviation 5.69
|
-3.58 Millimeters of mercury
Standard Deviation 5.10
|
2.67 Millimeters of mercury
Standard Deviation 3.66
|
-0.83 Millimeters of mercury
Standard Deviation 7.77
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 14, 4 Hours Post-dose; n=10,5,6,6,6,6
|
-6.65 Millimeters of mercury
Standard Deviation 7.12
|
-6.80 Millimeters of mercury
Standard Deviation 8.25
|
-3.58 Millimeters of mercury
Standard Deviation 4.87
|
-8.83 Millimeters of mercury
Standard Deviation 7.45
|
5.00 Millimeters of mercury
Standard Deviation 5.68
|
0.33 Millimeters of mercury
Standard Deviation 8.85
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Day 15; n=10,5,6,6,6,6
|
-6.75 Millimeters of mercury
Standard Deviation 10.22
|
1.30 Millimeters of mercury
Standard Deviation 7.13
|
2.00 Millimeters of mercury
Standard Deviation 7.47
|
-5.67 Millimeters of mercury
Standard Deviation 6.47
|
2.00 Millimeters of mercury
Standard Deviation 8.40
|
-4.08 Millimeters of mercury
Standard Deviation 7.28
|
—
|
—
|
|
Part B: Change From Baseline in SBP and DBP
DBP; Follow-up (Day 25); n=10,6,6,6,6,6
|
-5.85 Millimeters of mercury
Standard Deviation 8.87
|
-3.92 Millimeters of mercury
Standard Deviation 7.56
|
-1.75 Millimeters of mercury
Standard Deviation 5.10
|
-1.75 Millimeters of mercury
Standard Deviation 8.62
|
1.00 Millimeters of mercury
Standard Deviation 5.06
|
-1.17 Millimeters of mercury
Standard Deviation 10.63
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Pulse rate of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Pulse Rate in Cohort 1 and Cohort 3
Day 1; 1 Hour Post dose
|
-3.79 Beats per minute
Standard Deviation 6.30
|
-3.25 Beats per minute
Standard Deviation 4.39
|
-3.00 Beats per minute
Standard Deviation 6.66
|
-3.25 Beats per minute
Standard Deviation 6.93
|
-4.00 Beats per minute
Standard Deviation 7.44
|
-2.75 Beats per minute
Standard Deviation 5.69
|
-3.20 Beats per minute
Standard Deviation 5.38
|
—
|
|
Part A: Change From Baseline in Pulse Rate in Cohort 1 and Cohort 3
Day 1; 4 Hours Post dose
|
-6.42 Beats per minute
Standard Deviation 5.91
|
-4.92 Beats per minute
Standard Deviation 5.98
|
-4.67 Beats per minute
Standard Deviation 6.59
|
-0.75 Beats per minute
Standard Deviation 7.96
|
-6.90 Beats per minute
Standard Deviation 5.03
|
-3.67 Beats per minute
Standard Deviation 4.70
|
-3.40 Beats per minute
Standard Deviation 3.17
|
—
|
|
Part A: Change From Baseline in Pulse Rate in Cohort 1 and Cohort 3
Day 1; 12 Hours Post dose
|
2.38 Beats per minute
Standard Deviation 6.34
|
0.75 Beats per minute
Standard Deviation 3.40
|
5.83 Beats per minute
Standard Deviation 6.04
|
6.00 Beats per minute
Standard Deviation 3.10
|
0.40 Beats per minute
Standard Deviation 8.93
|
2.33 Beats per minute
Standard Deviation 3.88
|
2.40 Beats per minute
Standard Deviation 6.44
|
—
|
|
Part A: Change From Baseline in Pulse Rate in Cohort 1 and Cohort 3
Day 2
|
-1.46 Beats per minute
Standard Deviation 9.11
|
-3.33 Beats per minute
Standard Deviation 7.77
|
-2.42 Beats per minute
Standard Deviation 6.90
|
2.08 Beats per minute
Standard Deviation 4.57
|
-3.60 Beats per minute
Standard Deviation 7.21
|
-2.83 Beats per minute
Standard Deviation 2.14
|
-1.60 Beats per minute
Standard Deviation 3.60
|
—
|
|
Part A: Change From Baseline in Pulse Rate in Cohort 1 and Cohort 3
Day 3
|
0.54 Beats per minute
Standard Deviation 7.17
|
-0.08 Beats per minute
Standard Deviation 10.84
|
-1.75 Beats per minute
Standard Deviation 9.49
|
0.50 Beats per minute
Standard Deviation 7.06
|
-2.50 Beats per minute
Standard Deviation 10.62
|
-2.08 Beats per minute
Standard Deviation 5.44
|
0.50 Beats per minute
Standard Deviation 5.15
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3Population: Safety population
Pulse rate of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Pulse Rate in Cohort 2
Day 1; 1 Hour Post dose
|
1.50 Beats per minute
Standard Deviation 1.41
|
7.50 Beats per minute
Standard Deviation 0.71
|
0.42 Beats per minute
Standard Deviation 4.98
|
9.08 Beats per minute
Standard Deviation 4.33
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Pulse Rate in Cohort 2
Day 1; 4 Hours Post dose
|
1.75 Beats per minute
Standard Deviation 2.47
|
-1.00 Beats per minute
Standard Deviation 2.12
|
-1.33 Beats per minute
Standard Deviation 3.87
|
2.75 Beats per minute
Standard Deviation 3.95
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Pulse Rate in Cohort 2
Day 1; 12 Hours Post dose
|
7.00 Beats per minute
Standard Deviation 2.12
|
9.25 Beats per minute
Standard Deviation 0.35
|
9.33 Beats per minute
Standard Deviation 3.42
|
7.92 Beats per minute
Standard Deviation 2.76
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Pulse Rate in Cohort 2
Day 2
|
1.25 Beats per minute
Standard Deviation 3.89
|
3.00 Beats per minute
Standard Deviation 4.24
|
4.33 Beats per minute
Standard Deviation 4.74
|
3.17 Beats per minute
Standard Deviation 5.39
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Pulse Rate in Cohort 2
Day 3
|
8.00 Beats per minute
Standard Deviation 4.95
|
4.75 Beats per minute
Standard Deviation 3.18
|
6.92 Beats per minute
Standard Deviation 7.12
|
7.58 Beats per minute
Standard Deviation 8.29
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Pulse rate of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Pulse Rate
Day 11; n=10,6,6,6,6,6
|
1.45 Beats per minute
Standard Deviation 7.98
|
-2.58 Beats per minute
Standard Deviation 10.12
|
-1.75 Beats per minute
Standard Deviation 6.33
|
0.00 Beats per minute
Standard Deviation 6.75
|
0.42 Beats per minute
Standard Deviation 12.46
|
-3.58 Beats per minute
Standard Deviation 7.01
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 12; n=10,6,6,6,6,6
|
-0.50 Beats per minute
Standard Deviation 5.48
|
-1.17 Beats per minute
Standard Deviation 12.30
|
-2.33 Beats per minute
Standard Deviation 8.68
|
0.17 Beats per minute
Standard Deviation 4.69
|
1.75 Beats per minute
Standard Deviation 10.11
|
3.25 Beats per minute
Standard Deviation 11.02
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 13; n=10,6,6,6,6,6
|
2.45 Beats per minute
Standard Deviation 5.83
|
2.00 Beats per minute
Standard Deviation 9.70
|
-0.08 Beats per minute
Standard Deviation 8.63
|
2.92 Beats per minute
Standard Deviation 11.59
|
-2.25 Beats per minute
Standard Deviation 11.49
|
-2.08 Beats per minute
Standard Deviation 9.58
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Follow-up (Day 25); n=10,6,6,6,6,6
|
6.25 Beats per minute
Standard Deviation 8.77
|
0.00 Beats per minute
Standard Deviation 6.67
|
4.25 Beats per minute
Standard Deviation 4.41
|
10.58 Beats per minute
Standard Deviation 8.44
|
5.83 Beats per minute
Standard Deviation 13.14
|
6.92 Beats per minute
Standard Deviation 6.85
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 1; 4 Hours Post dose; n=10,6,6,6,6,6
|
-1.55 Beats per minute
Standard Deviation 4.75
|
-0.42 Beats per minute
Standard Deviation 8.65
|
-2.25 Beats per minute
Standard Deviation 4.16
|
-3.58 Beats per minute
Standard Deviation 4.90
|
-1.17 Beats per minute
Standard Deviation 7.13
|
-3.42 Beats per minute
Standard Deviation 5.74
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 2; n=10,6,6,6,6,6
|
3.35 Beats per minute
Standard Deviation 7.07
|
2.50 Beats per minute
Standard Deviation 10.80
|
-0.25 Beats per minute
Standard Deviation 5.52
|
0.50 Beats per minute
Standard Deviation 8.63
|
-2.67 Beats per minute
Standard Deviation 7.28
|
0.08 Beats per minute
Standard Deviation 6.41
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 3; n=10,6,6,6,6,6
|
4.85 Beats per minute
Standard Deviation 4.53
|
3.33 Beats per minute
Standard Deviation 7.05
|
0.58 Beats per minute
Standard Deviation 5.62
|
1.08 Beats per minute
Standard Deviation 8.34
|
-6.92 Beats per minute
Standard Deviation 8.45
|
-2.25 Beats per minute
Standard Deviation 5.35
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 4; n=10,6,6,6,6,6
|
3.25 Beats per minute
Standard Deviation 8.47
|
2.42 Beats per minute
Standard Deviation 10.53
|
-1.67 Beats per minute
Standard Deviation 3.80
|
1.33 Beats per minute
Standard Deviation 9.10
|
2.58 Beats per minute
Standard Deviation 9.16
|
-0.17 Beats per minute
Standard Deviation 6.77
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 5; n=10,6,6,6,6,6
|
-0.25 Beats per minute
Standard Deviation 6.03
|
-1.17 Beats per minute
Standard Deviation 9.03
|
2.75 Beats per minute
Standard Deviation 6.83
|
1.92 Beats per minute
Standard Deviation 9.09
|
-0.25 Beats per minute
Standard Deviation 9.96
|
3.92 Beats per minute
Standard Deviation 10.11
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 6; n=10,6,6,6,6,6
|
-0.50 Beats per minute
Standard Deviation 5.33
|
5.42 Beats per minute
Standard Deviation 11.74
|
-0.33 Beats per minute
Standard Deviation 8.94
|
-1.33 Beats per minute
Standard Deviation 8.24
|
0.08 Beats per minute
Standard Deviation 9.04
|
-2.67 Beats per minute
Standard Deviation 8.05
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 7, Pre-dose; n=10,6,6,6,6,6
|
-1.55 Beats per minute
Standard Deviation 5.23
|
0.25 Beats per minute
Standard Deviation 8.30
|
-0.25 Beats per minute
Standard Deviation 10.24
|
-0.75 Beats per minute
Standard Deviation 5.66
|
0.50 Beats per minute
Standard Deviation 9.44
|
-0.25 Beats per minute
Standard Deviation 5.40
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 7, 4 Hours Post-dose; n=10,6,6,6,6,6
|
0.20 Beats per minute
Standard Deviation 4.82
|
3.75 Beats per minute
Standard Deviation 10.14
|
-5.08 Beats per minute
Standard Deviation 5.38
|
-0.58 Beats per minute
Standard Deviation 5.52
|
-1.25 Beats per minute
Standard Deviation 7.29
|
1.17 Beats per minute
Standard Deviation 6.63
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 8; n=10,6,6,6,6,6
|
0.55 Beats per minute
Standard Deviation 7.37
|
1.42 Beats per minute
Standard Deviation 9.06
|
1.42 Beats per minute
Standard Deviation 6.15
|
2.08 Beats per minute
Standard Deviation 7.28
|
-0.17 Beats per minute
Standard Deviation 10.75
|
5.83 Beats per minute
Standard Deviation 6.93
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 9; n=10,6,6,6,6,6
|
1.05 Beats per minute
Standard Deviation 8.59
|
2.58 Beats per minute
Standard Deviation 7.01
|
0.83 Beats per minute
Standard Deviation 5.91
|
2.50 Beats per minute
Standard Deviation 5.59
|
-4.42 Beats per minute
Standard Deviation 12.73
|
2.67 Beats per minute
Standard Deviation 10.35
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 10; n=10,6,6,6,6,6
|
-0.10 Beats per minute
Standard Deviation 5.64
|
-1.83 Beats per minute
Standard Deviation 10.52
|
-4.33 Beats per minute
Standard Deviation 5.82
|
-0.25 Beats per minute
Standard Deviation 7.62
|
-3.33 Beats per minute
Standard Deviation 8.30
|
-2.17 Beats per minute
Standard Deviation 7.82
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 14, Pre-dose; n=10,6,6,6,6,6
|
-2.35 Beats per minute
Standard Deviation 3.93
|
0.25 Beats per minute
Standard Deviation 10.12
|
-1.50 Beats per minute
Standard Deviation 10.11
|
-2.17 Beats per minute
Standard Deviation 7.81
|
-0.17 Beats per minute
Standard Deviation 7.75
|
0.42 Beats per minute
Standard Deviation 4.89
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 14, 4 Hours Post-dose; n=10,5,6,6,6,6
|
0.40 Beats per minute
Standard Deviation 5.00
|
0.90 Beats per minute
Standard Deviation 11.06
|
-5.75 Beats per minute
Standard Deviation 4.26
|
-2.58 Beats per minute
Standard Deviation 7.39
|
3.83 Beats per minute
Standard Deviation 9.11
|
-0.08 Beats per minute
Standard Deviation 6.67
|
—
|
—
|
|
Part B: Change From Baseline in Pulse Rate
Day 15; n=10,5,6,6,6,6
|
0.85 Beats per minute
Standard Deviation 4.34
|
4.00 Beats per minute
Standard Deviation 5.28
|
6.17 Beats per minute
Standard Deviation 9.68
|
4.00 Beats per minute
Standard Deviation 6.57
|
5.58 Beats per minute
Standard Deviation 8.03
|
7.67 Beats per minute
Standard Deviation 6.05
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Body temperature of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Body Temperature in Cohort 1 and Cohort 3
Day 1; 12 Hours Post dose
|
-0.09 Celsius
Standard Deviation 0.29
|
0.00 Celsius
Standard Deviation 0.00
|
-0.22 Celsius
Standard Deviation 0.43
|
-0.15 Celsius
Standard Deviation 0.31
|
-0.12 Celsius
Standard Deviation 0.34
|
0.00 Celsius
Standard Deviation 0.00
|
-0.20 Celsius
Standard Deviation 0.24
|
—
|
|
Part A: Change From Baseline in Body Temperature in Cohort 1 and Cohort 3
Day 2
|
-0.04 Celsius
Standard Deviation 0.38
|
-0.13 Celsius
Standard Deviation 0.37
|
-0.27 Celsius
Standard Deviation 0.28
|
-0.30 Celsius
Standard Deviation 0.42
|
-0.58 Celsius
Standard Deviation 0.30
|
-0.22 Celsius
Standard Deviation 0.29
|
0.00 Celsius
Standard Deviation 0.25
|
—
|
|
Part A: Change From Baseline in Body Temperature in Cohort 1 and Cohort 3
Day 1; 4 Hours Post dose
|
-0.09 Celsius
Standard Deviation 0.29
|
0.00 Celsius
Standard Deviation 0.00
|
-0.22 Celsius
Standard Deviation 0.43
|
-0.15 Celsius
Standard Deviation 0.31
|
-0.12 Celsius
Standard Deviation 0.34
|
0.00 Celsius
Standard Deviation 0.00
|
-0.20 Celsius
Standard Deviation 0.24
|
—
|
|
Part A: Change From Baseline in Body Temperature in Cohort 1 and Cohort 3
Day 1; 1 Hour Post dose
|
-0.09 Celsius
Standard Deviation 0.29
|
0.00 Celsius
Standard Deviation 0.00
|
-0.22 Celsius
Standard Deviation 0.43
|
-0.15 Celsius
Standard Deviation 0.31
|
-0.12 Celsius
Standard Deviation 0.34
|
0.00 Celsius
Standard Deviation 0.00
|
-0.20 Celsius
Standard Deviation 0.24
|
—
|
|
Part A: Change From Baseline in Body Temperature in Cohort 1 and Cohort 3
Day 3
|
-0.07 Celsius
Standard Deviation 0.41
|
-0.18 Celsius
Standard Deviation 0.26
|
-0.45 Celsius
Standard Deviation 0.58
|
0.00 Celsius
Standard Deviation 0.49
|
-0.16 Celsius
Standard Deviation 0.59
|
0.10 Celsius
Standard Deviation 0.48
|
0.26 Celsius
Standard Deviation 0.48
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3Population: Safety population
Body temperature of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Body Temperature in Cohort 2
Day 1; 4 Hours Post dose
|
0.00 Celsius
Standard Deviation 0.00
|
-0.10 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.47
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Body Temperature in Cohort 2
Day 1; 1 Hour Post dose
|
0.00 Celsius
Standard Deviation 0.00
|
-0.10 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.47
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Body Temperature in Cohort 2
Day 1; 12 Hours Post dose
|
0.00 Celsius
Standard Deviation 0.00
|
-0.10 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.47
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Body Temperature in Cohort 2
Day 2
|
-0.15 Celsius
Standard Deviation 0.07
|
-0.15 Celsius
Standard Deviation 0.21
|
-0.33 Celsius
Standard Deviation 0.73
|
0.03 Celsius
Standard Deviation 0.39
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Body Temperature in Cohort 2
Day 3
|
-0.20 Celsius
Standard Deviation 0.14
|
-0.35 Celsius
Standard Deviation 0.07
|
-0.10 Celsius
Standard Deviation 0.49
|
-0.22 Celsius
Standard Deviation 0.56
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Body temperature of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Body Temperature
Day 3; n=10,6,6,6,6,6
|
0.09 Celsius
Standard Deviation 0.55
|
-0.10 Celsius
Standard Deviation 0.15
|
0.05 Celsius
Standard Deviation 0.49
|
0.45 Celsius
Standard Deviation 0.33
|
0.13 Celsius
Standard Deviation 0.52
|
0.03 Celsius
Standard Deviation 0.42
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 5; n=10,6,6,6,6,6
|
0.16 Celsius
Standard Deviation 0.32
|
0.18 Celsius
Standard Deviation 0.13
|
0.23 Celsius
Standard Deviation 0.38
|
0.05 Celsius
Standard Deviation 0.21
|
0.27 Celsius
Standard Deviation 0.38
|
-0.45 Celsius
Standard Deviation 0.38
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 6; n=10,6,6,6,6,6
|
0.17 Celsius
Standard Deviation 0.51
|
0.33 Celsius
Standard Deviation 0.28
|
-0.05 Celsius
Standard Deviation 0.48
|
0.53 Celsius
Standard Deviation 0.21
|
0.13 Celsius
Standard Deviation 0.57
|
0.05 Celsius
Standard Deviation 0.49
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 7, Pre-dose; n=10,6,6,6,6,6
|
0.18 Celsius
Standard Deviation 0.45
|
0.12 Celsius
Standard Deviation 0.30
|
0.08 Celsius
Standard Deviation 0.38
|
0.23 Celsius
Standard Deviation 0.18
|
0.02 Celsius
Standard Deviation 0.29
|
-0.08 Celsius
Standard Deviation 0.42
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 9; n=10,6,6,6,6,6
|
0.08 Celsius
Standard Deviation 0.40
|
0.15 Celsius
Standard Deviation 0.32
|
0.30 Celsius
Standard Deviation 0.23
|
0.15 Celsius
Standard Deviation 0.39
|
0.23 Celsius
Standard Deviation 0.45
|
-0.20 Celsius
Standard Deviation 0.62
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 12; n=10,6,6,6,6,6
|
-0.04 Celsius
Standard Deviation 0.67
|
0.00 Celsius
Standard Deviation 0.39
|
-0.23 Celsius
Standard Deviation 0.45
|
0.55 Celsius
Standard Deviation 0.26
|
-0.07 Celsius
Standard Deviation 0.45
|
-0.08 Celsius
Standard Deviation 0.41
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 13; n=10,6,6,6,6,6
|
-0.07 Celsius
Standard Deviation 0.42
|
0.03 Celsius
Standard Deviation 0.37
|
0.15 Celsius
Standard Deviation 0.48
|
-0.08 Celsius
Standard Deviation 0.18
|
0.05 Celsius
Standard Deviation 0.38
|
-0.12 Celsius
Standard Deviation 0.40
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 14, Pre-dose; n=10,6,6,6,6,6
|
0.17 Celsius
Standard Deviation 0.45
|
0.48 Celsius
Standard Deviation 0.31
|
0.27 Celsius
Standard Deviation 0.44
|
0.25 Celsius
Standard Deviation 0.31
|
-0.10 Celsius
Standard Deviation 0.31
|
-0.12 Celsius
Standard Deviation 0.48
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 4; n=10,6,6,6,6,6
|
0.07 Celsius
Standard Deviation 0.31
|
-0.10 Celsius
Standard Deviation 0.36
|
-0.07 Celsius
Standard Deviation 0.49
|
0.05 Celsius
Standard Deviation 0.20
|
0.07 Celsius
Standard Deviation 0.35
|
0.03 Celsius
Standard Deviation 0.36
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 1; 4 Hours Post dose; n=10,6,6,6,6,6
|
0.00 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.00
|
0.00 Celsius
Standard Deviation 0.00
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 2; n=10,6,6,6,6,6
|
0.05 Celsius
Standard Deviation 0.32
|
-0.03 Celsius
Standard Deviation 0.37
|
0.05 Celsius
Standard Deviation 0.30
|
-0.02 Celsius
Standard Deviation 0.43
|
0.13 Celsius
Standard Deviation 0.47
|
-0.20 Celsius
Standard Deviation 0.39
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 7, 4 Hours Post-dose; n=10,6,6,6,6,6
|
0.18 Celsius
Standard Deviation 0.45
|
0.12 Celsius
Standard Deviation 0.30
|
0.08 Celsius
Standard Deviation 0.38
|
0.23 Celsius
Standard Deviation 0.18
|
0.02 Celsius
Standard Deviation 0.29
|
-0.08 Celsius
Standard Deviation 0.42
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 8; n=10,6,6,6,6,6
|
0.17 Celsius
Standard Deviation 0.34
|
-0.02 Celsius
Standard Deviation 0.34
|
0.40 Celsius
Standard Deviation 0.37
|
0.08 Celsius
Standard Deviation 0.56
|
0.02 Celsius
Standard Deviation 0.54
|
-0.15 Celsius
Standard Deviation 0.61
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 10; n=10,6,6,6,6,6
|
-0.07 Celsius
Standard Deviation 0.51
|
0.17 Celsius
Standard Deviation 0.26
|
0.08 Celsius
Standard Deviation 0.45
|
-0.10 Celsius
Standard Deviation 0.49
|
-0.48 Celsius
Standard Deviation 0.60
|
-0.02 Celsius
Standard Deviation 0.32
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 11; n=10,6,6,6,6,6
|
-0.05 Celsius
Standard Deviation 0.47
|
0.05 Celsius
Standard Deviation 0.39
|
-0.02 Celsius
Standard Deviation 0.38
|
0.07 Celsius
Standard Deviation 0.42
|
0.00 Celsius
Standard Deviation 0.50
|
-0.02 Celsius
Standard Deviation 0.39
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 14, 4 Hours Post-dose; n=10,5,6,6,6,6
|
0.17 Celsius
Standard Deviation 0.45
|
0.42 Celsius
Standard Deviation 0.29
|
0.27 Celsius
Standard Deviation 0.44
|
0.25 Celsius
Standard Deviation 0.31
|
-0.10 Celsius
Standard Deviation 0.31
|
-0.12 Celsius
Standard Deviation 0.48
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Day 15; n=10,5,6,6,6,6
|
0.27 Celsius
Standard Deviation 0.35
|
0.10 Celsius
Standard Deviation 0.24
|
0.47 Celsius
Standard Deviation 0.46
|
0.30 Celsius
Standard Deviation 0.55
|
0.28 Celsius
Standard Deviation 0.47
|
0.03 Celsius
Standard Deviation 0.31
|
—
|
—
|
|
Part B: Change From Baseline in Body Temperature
Follow-up (Day 25); n=10,6,5,6,6,6
|
0.18 Celsius
Standard Deviation 0.58
|
0.17 Celsius
Standard Deviation 0.52
|
0.24 Celsius
Standard Deviation 0.61
|
0.68 Celsius
Standard Deviation 0.34
|
0.47 Celsius
Standard Deviation 0.32
|
0.08 Celsius
Standard Deviation 0.36
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 64 days in Cohort 1Population: Safety population
The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=8 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Different Stool Types Assessed Using Bristol Stool Form Scale (BSFS) in Cohort 1
Type 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using Bristol Stool Form Scale (BSFS) in Cohort 1
Type 5
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using Bristol Stool Form Scale (BSFS) in Cohort 1
Type 2
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using Bristol Stool Form Scale (BSFS) in Cohort 1
Type 3
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using Bristol Stool Form Scale (BSFS) in Cohort 1
Type 4
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using Bristol Stool Form Scale (BSFS) in Cohort 1
Type 6
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using Bristol Stool Form Scale (BSFS) in Cohort 1
Type 7
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days in Cohort 2Population: Safety population
The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 2
Type 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 2
Type 2
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 2
Type 3
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 2
Type 4
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 2
Type 5
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 2
Type 6
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 2
Type 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days in Cohort 3Population: Safety population
The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=4 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=5 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 3
Type 2
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 3
Type 1
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 3
Type 3
|
2 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 3
Type 4
|
2 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 3
Type 5
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 3
Type 6
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 3
Type 7
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day -1, Days 1-3, Days 4-7, Days 1-7, Days 8-14Population: Safety population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Average BSFS at Indicated Time Points
Day -1; n=7,4, 6,6,4,5
|
3.17 Units on a scale
Standard Deviation 1.30
|
3.88 Units on a scale
Standard Deviation 0.63
|
3.92 Units on a scale
Standard Deviation 0.49
|
3.92 Units on a scale
Standard Deviation 1.43
|
4.13 Units on a scale
Standard Deviation 1.03
|
4.30 Units on a scale
Standard Deviation 0.84
|
—
|
—
|
|
Part B: Average BSFS at Indicated Time Points
Days 1-3; n=10,6,6,6,6,6
|
3.93 Units on a scale
Standard Deviation 1.14
|
3.55 Units on a scale
Standard Deviation 1.57
|
3.97 Units on a scale
Standard Deviation 1.06
|
3.62 Units on a scale
Standard Deviation 0.71
|
3.75 Units on a scale
Standard Deviation 1.33
|
3.37 Units on a scale
Standard Deviation 0.91
|
—
|
—
|
|
Part B: Average BSFS at Indicated Time Points
Days 1-7;n=10,6,6,6,6,6
|
4.14 Units on a scale
Standard Deviation 0.99
|
3.75 Units on a scale
Standard Deviation 1.36
|
3.77 Units on a scale
Standard Deviation 0.86
|
3.48 Units on a scale
Standard Deviation 0.50
|
3.78 Units on a scale
Standard Deviation 1.08
|
3.38 Units on a scale
Standard Deviation 0.34
|
—
|
—
|
|
Part B: Average BSFS at Indicated Time Points
Days 8-14;n=10,6,6,6,6,6
|
4.12 Units on a scale
Standard Deviation 0.97
|
3.63 Units on a scale
Standard Deviation 1.12
|
3.93 Units on a scale
Standard Deviation 0.77
|
3.10 Units on a scale
Standard Deviation 0.63
|
3.63 Units on a scale
Standard Deviation 1.29
|
3.48 Units on a scale
Standard Deviation 0.48
|
—
|
—
|
|
Part B: Average BSFS at Indicated Time Points
Days 4-7;n=9,6,6,6,6,6
|
4.32 Units on a scale
Standard Deviation 1.14
|
3.78 Units on a scale
Standard Deviation 1.30
|
3.68 Units on a scale
Standard Deviation 1.14
|
3.37 Units on a scale
Standard Deviation 0.47
|
3.85 Units on a scale
Standard Deviation 0.95
|
3.45 Units on a scale
Standard Deviation 0.34
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 1 and Cohort 3
Lymphocytes; Day 3
|
-0.37 10^9 cells per liter
Standard Deviation 0.40
|
-0.10 10^9 cells per liter
Standard Deviation 0.40
|
-0.32 10^9 cells per liter
Standard Deviation 0.46
|
-0.43 10^9 cells per liter
Standard Deviation 0.36
|
-0.50 10^9 cells per liter
Standard Deviation 0.34
|
0.03 10^9 cells per liter
Standard Deviation 0.31
|
-0.16 10^9 cells per liter
Standard Deviation 0.29
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 1 and Cohort 3
Monocytes; Day 3
|
-0.05 10^9 cells per liter
Standard Deviation 0.12
|
-0.08 10^9 cells per liter
Standard Deviation 0.10
|
-0.13 10^9 cells per liter
Standard Deviation 0.08
|
-0.08 10^9 cells per liter
Standard Deviation 0.12
|
-0.04 10^9 cells per liter
Standard Deviation 0.21
|
0.03 10^9 cells per liter
Standard Deviation 0.08
|
0.02 10^9 cells per liter
Standard Deviation 0.04
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 1 and Cohort 3
Neutrophils; Day 3
|
-0.66 10^9 cells per liter
Standard Deviation 1.05
|
-0.73 10^9 cells per liter
Standard Deviation 1.06
|
-0.60 10^9 cells per liter
Standard Deviation 1.55
|
-0.23 10^9 cells per liter
Standard Deviation 0.70
|
-0.16 10^9 cells per liter
Standard Deviation 2.76
|
-0.60 10^9 cells per liter
Standard Deviation 0.85
|
-0.36 10^9 cells per liter
Standard Deviation 0.90
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 1 and Cohort 3
Platelets; Day 3
|
-15.0 10^9 cells per liter
Standard Deviation 34.6
|
-4.8 10^9 cells per liter
Standard Deviation 34.1
|
-22.5 10^9 cells per liter
Standard Deviation 45.6
|
2.2 10^9 cells per liter
Standard Deviation 32.4
|
-8.0 10^9 cells per liter
Standard Deviation 43.7
|
-23.3 10^9 cells per liter
Standard Deviation 13.9
|
-46.6 10^9 cells per liter
Standard Deviation 36.5
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 1 and Cohort 3
Leukocytes ;Day 3
|
-1.01 10^9 cells per liter
Standard Deviation 1.06
|
-0.88 10^9 cells per liter
Standard Deviation 0.95
|
-0.95 10^9 cells per liter
Standard Deviation 1.33
|
-0.82 10^9 cells per liter
Standard Deviation 0.80
|
-0.58 10^9 cells per liter
Standard Deviation 2.64
|
-0.53 10^9 cells per liter
Standard Deviation 0.94
|
-0.52 10^9 cells per liter
Standard Deviation 0.94
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 1 and Cohort 3
Basophils; Day 3
|
0.01 10^9 cells per liter
Standard Deviation 0.05
|
0.00 10^9 cells per liter
Standard Deviation 0.06
|
0.02 10^9 cells per liter
Standard Deviation 0.04
|
0.00 10^9 cells per liter
Standard Deviation 0.06
|
0.04 10^9 cells per liter
Standard Deviation 0.05
|
-0.03 10^9 cells per liter
Standard Deviation 0.05
|
-0.05 10^9 cells per liter
Standard Deviation 0.05
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 1 and Cohort 3
Eosinophils; Day 3
|
0.02 10^9 cells per liter
Standard Deviation 0.06
|
0.02 10^9 cells per liter
Standard Deviation 0.08
|
0.05 10^9 cells per liter
Standard Deviation 0.14
|
-0.03 10^9 cells per liter
Standard Deviation 0.05
|
0.02 10^9 cells per liter
Standard Deviation 0.05
|
0.02 10^9 cells per liter
Standard Deviation 0.04
|
0.04 10^9 cells per liter
Standard Deviation 0.05
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 2
Basophils; Day 3
|
0.00 10^9 cells per liter
Standard Deviation 0.00
|
0.00 10^9 cells per liter
Standard Deviation 0.00
|
0.00 10^9 cells per liter
Standard Deviation 0.00
|
0.02 10^9 cells per liter
Standard Deviation 0.04
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 2
Monocytes; Day 3
|
-0.05 10^9 cells per liter
Standard Deviation 0.07
|
-0.05 10^9 cells per liter
Standard Deviation 0.07
|
-0.02 10^9 cells per liter
Standard Deviation 0.15
|
-0.08 10^9 cells per liter
Standard Deviation 0.10
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 2
Neutrophils; Day 3
|
-1.00 10^9 cells per liter
Standard Deviation 0.42
|
-0.85 10^9 cells per liter
Standard Deviation 0.35
|
-1.25 10^9 cells per liter
Standard Deviation 1.97
|
-1.73 10^9 cells per liter
Standard Deviation 1.84
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 2
Platelets; Day 3
|
-7.0 10^9 cells per liter
Standard Deviation 11.3
|
-45.0 10^9 cells per liter
Standard Deviation 26.9
|
-7.2 10^9 cells per liter
Standard Deviation 5.9
|
-29.2 10^9 cells per liter
Standard Deviation 27.0
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 2
Eosinophils; Day 3
|
0.05 10^9 cells per liter
Standard Deviation 0.08
|
0.05 10^9 cells per liter
Standard Deviation 0.07
|
0.00 10^9 cells per liter
Standard Deviation 0.06
|
0.03 10^9 cells per liter
Standard Deviation 0.06
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 2
Lymphocytes; Day 3
|
0.10 10^9 cells per liter
Standard Deviation 0.14
|
0.10 10^9 cells per liter
Standard Deviation 0.14
|
0.25 10^9 cells per liter
Standard Deviation 0.65
|
0.12 10^9 cells per liter
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 2
Leukocytes ;Day 3
|
-0.90 10^9 cells per liter
Standard Deviation 0.57
|
-0.75 10^9 cells per liter
Standard Deviation 0.35
|
-1.00 10^9 cells per liter
Standard Deviation 2.44
|
-1.68 10^9 cells per liter
Standard Deviation 2.30
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Basophils; Day 7;n=10, 6,6,6,6,6
|
0.03 10^9 cells per liter
Standard Deviation 0.06
|
0.00 10^9 cells per liter
Standard Deviation 0.06
|
0.05 10^9 cells per liter
Standard Deviation 0.05
|
0.03 10^9 cells per liter
Standard Deviation 0.05
|
0.02 10^9 cells per liter
Standard Deviation 0.04
|
0.02 10^9 cells per liter
Standard Deviation 0.04
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Basophils; Day 15;n=10, 5,6,6,6,6
|
0.03 10^9 cells per liter
Standard Deviation 0.06
|
0.04 10^9 cells per liter
Standard Deviation 0.05
|
0.05 10^9 cells per liter
Standard Deviation 0.05
|
0.05 10^9 cells per liter
Standard Deviation 0.05
|
0.03 10^9 cells per liter
Standard Deviation 0.05
|
0.02 10^9 cells per liter
Standard Deviation 0.04
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Basophils; Follow-up (Day 25) ; n=10, 6,6,6,6,6
|
0.05 10^9 cells per liter
Standard Deviation 0.05
|
0.00 10^9 cells per liter
Standard Deviation 0.06
|
0.06 10^9 cells per liter
Standard Deviation 0.05
|
0.05 10^9 cells per liter
Standard Deviation 0.05
|
0.02 10^9 cells per liter
Standard Deviation 0.07
|
0.00 10^9 cells per liter
Standard Deviation 0.00
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Eosinophils; Day 7;n=10, 6,6,6,6,6
|
0.01 10^9 cells per liter
Standard Deviation 0.09
|
0.03 10^9 cells per liter
Standard Deviation 0.05
|
-0.02 10^9 cells per liter
Standard Deviation 0.04
|
0.03 10^9 cells per liter
Standard Deviation 0.08
|
0.05 10^9 cells per liter
Standard Deviation 0.05
|
0.04 10^9 cells per liter
Standard Deviation 0.08
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Eosinophils; Follow-up (Day 25); n=10, 6,6,6,6,6
|
0.01 10^9 cells per liter
Standard Deviation 0.09
|
0.05 10^9 cells per liter
Standard Deviation 0.09
|
0.04 10^9 cells per liter
Standard Deviation 0.05
|
0.03 10^9 cells per liter
Standard Deviation 0.10
|
0.05 10^9 cells per liter
Standard Deviation 0.08
|
-0.03 10^9 cells per liter
Standard Deviation 0.11
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Lymphocytes; Day 15; n=10, 5,6,6,6,6
|
0.04 10^9 cells per liter
Standard Deviation 0.32
|
0.02 10^9 cells per liter
Standard Deviation 0.22
|
0.10 10^9 cells per liter
Standard Deviation 0.20
|
-0.05 10^9 cells per liter
Standard Deviation 0.36
|
0.40 10^9 cells per liter
Standard Deviation 0.25
|
-0.10 10^9 cells per liter
Standard Deviation 0.19
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Neutrophils; Day 15;n=10, 5,6,6,6,6
|
-0.31 10^9 cells per liter
Standard Deviation 0.74
|
-0.02 10^9 cells per liter
Standard Deviation 0.39
|
-0.22 10^9 cells per liter
Standard Deviation 0.77
|
-0.72 10^9 cells per liter
Standard Deviation 0.87
|
-0.58 10^9 cells per liter
Standard Deviation 0.50
|
-0.95 10^9 cells per liter
Standard Deviation 0.75
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Platelets; Follow-up (Day 25); n=10, 6,6,6,6,6
|
17.5 10^9 cells per liter
Standard Deviation 34.5
|
37.3 10^9 cells per liter
Standard Deviation 24.3
|
26.2 10^9 cells per liter
Standard Deviation 24.2
|
27.3 10^9 cells per liter
Standard Deviation 37.0
|
2.5 10^9 cells per liter
Standard Deviation 20.9
|
2.5 10^9 cells per liter
Standard Deviation 9.0
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Leukocytes; Day 7;n=10, 6,6,6,6,6
|
-0.18 10^9 cells per liter
Standard Deviation 1.13
|
-0.32 10^9 cells per liter
Standard Deviation 0.52
|
-0.65 10^9 cells per liter
Standard Deviation 0.60
|
-0.82 10^9 cells per liter
Standard Deviation 1.00
|
-0.53 10^9 cells per liter
Standard Deviation 0.92
|
-1.08 10^9 cells per liter
Standard Deviation 0.67
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Eosinophils, Day 15;n=10, 5,6,6,6,6
|
0.02 10^9 cells per liter
Standard Deviation 0.10
|
0.04 10^9 cells per liter
Standard Deviation 0.11
|
0.02 10^9 cells per liter
Standard Deviation 0.04
|
0.03 10^9 cells per liter
Standard Deviation 0.08
|
0.05 10^9 cells per liter
Standard Deviation 0.05
|
-0.03 10^9 cells per liter
Standard Deviation 0.08
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Lymphocytes; Day 7 ;n=10, 6,6,6,6,6
|
-0.09 10^9 cells per liter
Standard Deviation 0.35
|
-0.35 10^9 cells per liter
Standard Deviation 0.26
|
-0.18 10^9 cells per liter
Standard Deviation 0.24
|
-0.10 10^9 cells per liter
Standard Deviation 0.30
|
0.23 10^9 cells per liter
Standard Deviation 0.19
|
-0.22 10^9 cells per liter
Standard Deviation 0.40
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Lymphocytes; Follow-up (Day 25); n=10, 6,6,6,6,6
|
0.14 10^9 cells per liter
Standard Deviation 0.25
|
-0.12 10^9 cells per liter
Standard Deviation 0.33
|
0.25 10^9 cells per liter
Standard Deviation 0.35
|
0.00 10^9 cells per liter
Standard Deviation 0.13
|
0.07 10^9 cells per liter
Standard Deviation 0.23
|
-0.32 10^9 cells per liter
Standard Deviation 0.17
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Monocytes; Day 7;n=10, 6,6,6,6,6
|
-0.03 10^9 cells per liter
Standard Deviation 0.09
|
-0.03 10^9 cells per liter
Standard Deviation 0.05
|
-0.08 10^9 cells per liter
Standard Deviation 0.12
|
-0.10 10^9 cells per liter
Standard Deviation 0.06
|
0.05 10^9 cells per liter
Standard Deviation 0.10
|
0.02 10^9 cells per liter
Standard Deviation 0.08
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Monocytes; Day 15;n=10, 5,6,6,6,6
|
-0.09 10^9 cells per liter
Standard Deviation 0.11
|
-0.02 10^9 cells per liter
Standard Deviation 0.04
|
-0.02 10^9 cells per liter
Standard Deviation 0.08
|
-0.10 10^9 cells per liter
Standard Deviation 0.09
|
0.05 10^9 cells per liter
Standard Deviation 0.05
|
-0.07 10^9 cells per liter
Standard Deviation 0.08
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Monocytes; Follow-up (Day 25); n=10, 6,6,6,6,6
|
-0.04 10^9 cells per liter
Standard Deviation 0.12
|
-0.05 10^9 cells per liter
Standard Deviation 0.10
|
0.03 10^9 cells per liter
Standard Deviation 0.08
|
-0.10 10^9 cells per liter
Standard Deviation 0.06
|
0.17 10^9 cells per liter
Standard Deviation 0.27
|
-0.07 10^9 cells per liter
Standard Deviation 0.10
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Neutrophils; Day 7;n=10, 6,6,6,6,6
|
-0.08 10^9 cells per liter
Standard Deviation 1.05
|
0.05 10^9 cells per liter
Standard Deviation 0.57
|
-0.42 10^9 cells per liter
Standard Deviation 0.34
|
-0.65 10^9 cells per liter
Standard Deviation 0.98
|
-0.82 10^9 cells per liter
Standard Deviation 0.79
|
-0.88 10^9 cells per liter
Standard Deviation 0.57
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Neutrophils; Follow-up (Day 25); n=10, 6,6,6,6,6
|
-0.55 10^9 cells per liter
Standard Deviation 0.94
|
0.05 10^9 cells per liter
Standard Deviation 0.42
|
0.07 10^9 cells per liter
Standard Deviation 0.66
|
-0.37 10^9 cells per liter
Standard Deviation 1.33
|
0.73 10^9 cells per liter
Standard Deviation 3.34
|
-0.58 10^9 cells per liter
Standard Deviation 1.05
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Platelets; Day 7;n=10, 6,6,6,6,6
|
10.4 10^9 cells per liter
Standard Deviation 25.0
|
9.7 10^9 cells per liter
Standard Deviation 21.9
|
8.3 10^9 cells per liter
Standard Deviation 20.8
|
26.7 10^9 cells per liter
Standard Deviation 12.1
|
-11.0 10^9 cells per liter
Standard Deviation 12.1
|
4.5 10^9 cells per liter
Standard Deviation 21.1
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Platelets; Day 15;n=10, 5,6,6,6,6
|
12.3 10^9 cells per liter
Standard Deviation 28.5
|
24.2 10^9 cells per liter
Standard Deviation 26.7
|
-3.0 10^9 cells per liter
Standard Deviation 23.9
|
3.7 10^9 cells per liter
Standard Deviation 16.6
|
7.3 10^9 cells per liter
Standard Deviation 25.5
|
7.5 10^9 cells per liter
Standard Deviation 21.3
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Leukocytes ;Day 15;n=10, 5,6,6,6,6
|
-0.32 10^9 cells per liter
Standard Deviation 0.79
|
0.10 10^9 cells per liter
Standard Deviation 0.47
|
-0.13 10^9 cells per liter
Standard Deviation 0.76
|
-0.82 10^9 cells per liter
Standard Deviation 0.85
|
-0.08 10^9 cells per liter
Standard Deviation 0.45
|
-1.10 10^9 cells per liter
Standard Deviation 0.62
|
—
|
—
|
|
Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes
Leukocytes; Follow-up (Day 25); n=10, 6,6,6,6,6
|
-0.39 10^9 cells per liter
Standard Deviation 0.72
|
-0.12 10^9 cells per liter
Standard Deviation 0.59
|
0.43 10^9 cells per liter
Standard Deviation 0.88
|
-0.45 10^9 cells per liter
Standard Deviation 1.24
|
0.98 10^9 cells per liter
Standard Deviation 3.38
|
-1.00 10^9 cells per liter
Standard Deviation 1.01
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood samples were collected for analysis of hematology parameters including Erythrocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Erythrocytes in Cohort 1 and 3
|
0.029 10^12 cells per liter
Standard Deviation 0.260
|
0.275 10^12 cells per liter
Standard Deviation 0.321
|
-0.073 10^12 cells per liter
Standard Deviation 0.310
|
0.112 10^12 cells per liter
Standard Deviation 0.390
|
0.120 10^12 cells per liter
Standard Deviation 0.373
|
0.063 10^12 cells per liter
Standard Deviation 0.094
|
-0.132 10^12 cells per liter
Standard Deviation 0.132
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Blood samples were collected for analysis of hematology parameters including Erythrocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Erythrocytes in Cohort 2
|
0.110 10^12 cells per liter
Standard Deviation 0.156
|
0.150 10^12 cells per liter
Standard Deviation 0.269
|
0.167 10^12 cells per liter
Standard Deviation 0.118
|
0.042 10^12 cells per liter
Standard Deviation 0.157
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected for analysis of hematology parameters including Erythrocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Erythrocytes
Day 7; n=10,6,6,6,6,6
|
0.081 10^12 cells per liter
Standard Deviation 0.250
|
0.208 10^12 cells per liter
Standard Deviation 0.119
|
0.033 10^12 cells per liter
Standard Deviation 0.060
|
0.230 10^12 cells per liter
Standard Deviation 0.145
|
-0.183 10^12 cells per liter
Standard Deviation 0.183
|
-0.023 10^12 cells per liter
Standard Deviation 0.251
|
—
|
—
|
|
Part B: Change From Baseline in Erythrocytes
Day 15; n=10,5,6,6,6,6
|
0.175 10^12 cells per liter
Standard Deviation 0.258
|
0.334 10^12 cells per liter
Standard Deviation 0.235
|
0.270 10^12 cells per liter
Standard Deviation 0.190
|
0.302 10^12 cells per liter
Standard Deviation 0.179
|
0.162 10^12 cells per liter
Standard Deviation 0.252
|
0.082 10^12 cells per liter
Standard Deviation 0.275
|
—
|
—
|
|
Part B: Change From Baseline in Erythrocytes
Follow-up (Day 25); n=10,6,6,6,6,6
|
0.075 10^12 cells per liter
Standard Deviation 0.355
|
0.287 10^12 cells per liter
Standard Deviation 0.256
|
0.155 10^12 cells per liter
Standard Deviation 0.182
|
0.158 10^12 cells per liter
Standard Deviation 0.239
|
-0.195 10^12 cells per liter
Standard Deviation 0.165
|
-0.227 10^12 cells per liter
Standard Deviation 0.157
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood samples were collected for analysis of hematology parameters including hemoglobin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Hemoglobin in Cohort 1 and 3
|
0.0 Grams per liter
Standard Deviation 8.3
|
6.2 Grams per liter
Standard Deviation 9.0
|
-2.5 Grams per liter
Standard Deviation 9.3
|
2.0 Grams per liter
Standard Deviation 9.0
|
-0.8 Grams per liter
Standard Deviation 8.8
|
2.2 Grams per liter
Standard Deviation 4.3
|
-1.2 Grams per liter
Standard Deviation 4.3
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Blood samples were collected for analysis of hematology parameters including hemoglobin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Hemoglobin in Cohort 2
|
4.0 Grams per liter
Standard Deviation 2.8
|
5.5 Grams per liter
Standard Deviation 9.2
|
5.8 Grams per liter
Standard Deviation 3.3
|
2.3 Grams per liter
Standard Deviation 3.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected for analysis of hematology parameters including hemoglobin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hemoglobin
Follow-up (Day 25); n=10,6,6,6,6,6
|
-1.3 Grams per liter
Standard Deviation 10.4
|
4.3 Grams per liter
Standard Deviation 7.1
|
-1.8 Grams per liter
Standard Deviation 5.6
|
-0.3 Grams per liter
Standard Deviation 5.9
|
-3.5 Grams per liter
Standard Deviation 4.5
|
-3.0 Grams per liter
Standard Deviation 4.6
|
—
|
—
|
|
Part B: Change From Baseline in Hemoglobin
Day 7; n=10,6,6,6,6,6
|
-1.8 Grams per liter
Standard Deviation 6.5
|
1.8 Grams per liter
Standard Deviation 4.5
|
-5.3 Grams per liter
Standard Deviation 2.0
|
0.7 Grams per liter
Standard Deviation 4.1
|
-6.7 Grams per liter
Standard Deviation 4.3
|
0.0 Grams per liter
Standard Deviation 6.9
|
—
|
—
|
|
Part B: Change From Baseline in Hemoglobin
Day 15; n=10,5,6,6,6,6
|
1.4 Grams per liter
Standard Deviation 8.7
|
6.4 Grams per liter
Standard Deviation 6.7
|
1.3 Grams per liter
Standard Deviation 5.6
|
3.7 Grams per liter
Standard Deviation 5.4
|
2.2 Grams per liter
Standard Deviation 4.9
|
3.7 Grams per liter
Standard Deviation 6.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood samples were collected for analysis of hematology parameters including Erythrocyte MCV. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) in Cohort 1 and Cohort 3
|
0.9 Femtoliter
Standard Deviation 1.1
|
0.2 Femtoliter
Standard Deviation 1.5
|
1.5 Femtoliter
Standard Deviation 0.8
|
1.7 Femtoliter
Standard Deviation 1.2
|
1.6 Femtoliter
Standard Deviation 1.1
|
0.8 Femtoliter
Standard Deviation 0.8
|
1.0 Femtoliter
Standard Deviation 1.6
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Blood samples were collected for analysis of hematology parameters including Erythrocyte MCV. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Erythrocyte MCV in Cohort 2
|
-2.0 Femtoliter
Standard Deviation 1.4
|
-2.0 Femtoliter
Standard Deviation 1.4
|
1.5 Femtoliter
Standard Deviation 3.0
|
0.7 Femtoliter
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected for analysis of hematology parameters including Erythrocyte MCV. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Erythrocyte MCV
Day 15; n=10,5,6,6,6,6
|
-1.0 Femtoliter
Standard Deviation 1.2
|
0.2 Femtoliter
Standard Deviation 1.9
|
-2.2 Femtoliter
Standard Deviation 1.7
|
-0.3 Femtoliter
Standard Deviation 1.4
|
0.8 Femtoliter
Standard Deviation 1.2
|
-0.8 Femtoliter
Standard Deviation 1.9
|
—
|
—
|
|
Part B: Change From Baseline in Erythrocyte MCV
Day 7; n=10,6,6,6,6,6
|
-1.4 Femtoliter
Standard Deviation 1.6
|
0.2 Femtoliter
Standard Deviation 1.2
|
-2.7 Femtoliter
Standard Deviation 1.8
|
-0.2 Femtoliter
Standard Deviation 0.8
|
0.2 Femtoliter
Standard Deviation 1.2
|
-1.3 Femtoliter
Standard Deviation 1.5
|
—
|
—
|
|
Part B: Change From Baseline in Erythrocyte MCV
Follow-up (Day 25); n=10,6,6,6,6,6
|
-0.5 Femtoliter
Standard Deviation 1.9
|
0.0 Femtoliter
Standard Deviation 1.4
|
-1.5 Femtoliter
Standard Deviation 1.9
|
0.3 Femtoliter
Standard Deviation 0.8
|
1.8 Femtoliter
Standard Deviation 0.4
|
0.0 Femtoliter
Standard Deviation 0.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood samples were collected for analysis of hematology parameters including Erythorocyte MCH. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Erythorocyte Mean Corpuscular Hemoglobin (MCH) in Cohort 1 and 3
|
-0.19 Picogram
Standard Deviation 0.71
|
-0.37 Picogram
Standard Deviation 0.47
|
-0.13 Picogram
Standard Deviation 0.40
|
-0.25 Picogram
Standard Deviation 0.66
|
-0.84 Picogram
Standard Deviation 0.52
|
0.08 Picogram
Standard Deviation 0.35
|
0.54 Picogram
Standard Deviation 0.43
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Blood samples were collected for analysis of hematology parameters including Erythorocyte MCH. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Erythrocyte MCH in Cohort 2
|
0.20 Picogram
Standard Deviation 0.28
|
0.20 Picogram
Standard Deviation 0.28
|
0.20 Picogram
Standard Deviation 0.37
|
0.27 Picogram
Standard Deviation 0.23
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected for analysis of hematology parameters including Erythorocyte MCH. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Erythrocyte MCH
Day 7; n=10,6,6,6,6,6
|
-0.87 Picogram
Standard Deviation 0.55
|
-0.87 Picogram
Standard Deviation 0.37
|
-1.25 Picogram
Standard Deviation 0.40
|
-1.13 Picogram
Standard Deviation 0.21
|
-0.28 Picogram
Standard Deviation 0.34
|
0.13 Picogram
Standard Deviation 0.85
|
—
|
—
|
|
Part B: Change From Baseline in Erythrocyte MCH
Day 15; n=10,5,6,6,6,6
|
-0.77 Picogram
Standard Deviation 0.72
|
-0.70 Picogram
Standard Deviation 0.37
|
-1.33 Picogram
Standard Deviation 0.14
|
-0.95 Picogram
Standard Deviation 0.38
|
-0.50 Picogram
Standard Deviation 0.46
|
0.23 Picogram
Standard Deviation 0.81
|
—
|
—
|
|
Part B: Change From Baseline in Erythrocyte MCH
Follow-up (Day 25); n=10,6,6,6,6,6
|
-0.72 Picogram
Standard Deviation 0.57
|
-0.78 Picogram
Standard Deviation 0.58
|
-1.30 Picogram
Standard Deviation 0.25
|
-0.98 Picogram
Standard Deviation 0.26
|
0.47 Picogram
Standard Deviation 0.39
|
0.77 Picogram
Standard Deviation 0.54
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood samples were collected for analysis of hematology parameters including Hematocrit. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Hematocrit in Cohort 1 and 3
|
0.007 Proportion of red blood cells in blood
Standard Deviation 0.021
|
0.025 Proportion of red blood cells in blood
Standard Deviation 0.027
|
0.002 Proportion of red blood cells in blood
Standard Deviation 0.029
|
0.017 Proportion of red blood cells in blood
Standard Deviation 0.031
|
0.018 Proportion of red blood cells in blood
Standard Deviation 0.026
|
0.007 Proportion of red blood cells in blood
Standard Deviation 0.008
|
-0.008 Proportion of red blood cells in blood
Standard Deviation 0.015
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Blood samples were collected for analysis of hematology parameters including Hematocrit. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Hematocrit in Cohort 2
|
0.005 Proportion of red blood cells in blood
Standard Deviation 0.021
|
0.010 Proportion of red blood cells in blood
Standard Deviation 0.028
|
0.023 Proportion of red blood cells in blood
Standard Deviation 0.020
|
0.008 Proportion of red blood cells in blood
Standard Deviation 0.015
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected for analysis of hematology parameters including Hematocrit. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Hematocrit
Day 7; n=10,6,6,6,6,6
|
0.000 Proportion of red blood cells in blood
Standard Deviation 0.029
|
0.018 Proportion of red blood cells in blood
Standard Deviation 0.010
|
-0.012 Proportion of red blood cells in blood
Standard Deviation 0.012
|
0.018 Proportion of red blood cells in blood
Standard Deviation 0.013
|
-0.017 Proportion of red blood cells in blood
Standard Deviation 0.014
|
-0.007 Proportion of red blood cells in blood
Standard Deviation 0.020
|
—
|
—
|
|
Part B: Change From Baseline in Hematocrit
Day 15; n=10,5,6,6,6,6
|
0.009 Proportion of red blood cells in blood
Standard Deviation 0.025
|
0.030 Proportion of red blood cells in blood
Standard Deviation 0.025
|
0.015 Proportion of red blood cells in blood
Standard Deviation 0.018
|
0.025 Proportion of red blood cells in blood
Standard Deviation 0.016
|
0.017 Proportion of red blood cells in blood
Standard Deviation 0.019
|
0.005 Proportion of red blood cells in blood
Standard Deviation 0.026
|
—
|
—
|
|
Part B: Change From Baseline in Hematocrit
Follow-up (Day 25); n=10,6,6,6,6,6
|
0.005 Proportion of red blood cells in blood
Standard Deviation 0.032
|
0.025 Proportion of red blood cells in blood
Standard Deviation 0.021
|
0.005 Proportion of red blood cells in blood
Standard Deviation 0.016
|
0.017 Proportion of red blood cells in blood
Standard Deviation 0.020
|
-0.008 Proportion of red blood cells in blood
Standard Deviation 0.015
|
-0.020 Proportion of red blood cells in blood
Standard Deviation 0.017
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and Alk Phos. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Alanine Aminotransferase (ALT),Aspartate Aminotransferase (AST), Alkaline Phosphatase (Alk Phos) in Cohort 1 and 3
AST; Day 3
|
1.3 Units per liter
Standard Deviation 10.3
|
1.0 Units per liter
Standard Deviation 8.1
|
-0.2 Units per liter
Standard Deviation 5.3
|
-0.2 Units per liter
Standard Deviation 5.3
|
-1.8 Units per liter
Standard Deviation 4.7
|
-5.0 Units per liter
Standard Deviation 5.2
|
-3.4 Units per liter
Standard Deviation 5.5
|
—
|
|
Part A: Change From Baseline in Alanine Aminotransferase (ALT),Aspartate Aminotransferase (AST), Alkaline Phosphatase (Alk Phos) in Cohort 1 and 3
Alk Phos; Day 3
|
-5.9 Units per liter
Standard Deviation 11.7
|
-7.3 Units per liter
Standard Deviation 7.5
|
-9.2 Units per liter
Standard Deviation 8.9
|
-10.5 Units per liter
Standard Deviation 8.7
|
-17.0 Units per liter
Standard Deviation 6.6
|
0.2 Units per liter
Standard Deviation 6.5
|
-3.6 Units per liter
Standard Deviation 8.2
|
—
|
|
Part A: Change From Baseline in Alanine Aminotransferase (ALT),Aspartate Aminotransferase (AST), Alkaline Phosphatase (Alk Phos) in Cohort 1 and 3
ALT; Day 3
|
5.0 Units per liter
Standard Deviation 27.1
|
-1.8 Units per liter
Standard Deviation 15.0
|
-6.2 Units per liter
Standard Deviation 12.4
|
-1.2 Units per liter
Standard Deviation 14.2
|
-7.2 Units per liter
Standard Deviation 15.6
|
6.0 Units per liter
Standard Deviation 3.2
|
8.0 Units per liter
Standard Deviation 9.3
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and Alk Phos. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in ALT, AST and Alk Phos in Cohort 2
ALT; Day 3
|
-1.5 Units per liter
Standard Deviation 0.7
|
-0.5 Units per liter
Standard Deviation 2.1
|
0.2 Units per liter
Standard Deviation 1.5
|
-2.3 Units per liter
Standard Deviation 5.6
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in ALT, AST and Alk Phos in Cohort 2
Alk Phos; Day 3
|
-6.0 Units per liter
Standard Deviation 5.7
|
-10.0 Units per liter
Standard Deviation 4.2
|
0.8 Units per liter
Standard Deviation 5.8
|
-2.0 Units per liter
Standard Deviation 4.6
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in ALT, AST and Alk Phos in Cohort 2
AST; Day 3
|
-4.5 Units per liter
Standard Deviation 0.7
|
-1.5 Units per liter
Standard Deviation 2.1
|
-4.5 Units per liter
Standard Deviation 3.3
|
-4.3 Units per liter
Standard Deviation 4.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected for analysis of hematology parameters including ALT, AST and Alk Phos. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in ALT, AST and Alk Phos
ALT; Day 7; n=10,6,6,6,6,6
|
-4.8 Units per liter
Standard Deviation 10.9
|
-7.7 Units per liter
Standard Deviation 5.9
|
-6.2 Units per liter
Standard Deviation 6.0
|
2.3 Units per liter
Standard Deviation 5.5
|
-0.8 Units per liter
Standard Deviation 2.8
|
-0.3 Units per liter
Standard Deviation 2.4
|
—
|
—
|
|
Part B: Change From Baseline in ALT, AST and Alk Phos
Alk Phos ; Follow-up (Day 25); n=10,6,6,6,6,6
|
-3.5 Units per liter
Standard Deviation 8.0
|
-7.8 Units per liter
Standard Deviation 17.8
|
-6.2 Units per liter
Standard Deviation 8.8
|
1.2 Units per liter
Standard Deviation 12.4
|
-0.7 Units per liter
Standard Deviation 7.1
|
0.7 Units per liter
Standard Deviation 3.0
|
—
|
—
|
|
Part B: Change From Baseline in ALT, AST and Alk Phos
ALT; Follow-up (Day 25); n=10,6,6,6,6,6
|
-5.3 Units per liter
Standard Deviation 9.0
|
-7.8 Units per liter
Standard Deviation 5.3
|
-9.3 Units per liter
Standard Deviation 7.7
|
-1.0 Units per liter
Standard Deviation 6.8
|
0.3 Units per liter
Standard Deviation 7.6
|
-2.3 Units per liter
Standard Deviation 3.3
|
—
|
—
|
|
Part B: Change From Baseline in ALT, AST and Alk Phos
AST ; Day 7; n=10,6,6,6,6,6
|
2.8 Units per liter
Standard Deviation 18.5
|
0.3 Units per liter
Standard Deviation 4.5
|
3.5 Units per liter
Standard Deviation 7.7
|
7.7 Units per liter
Standard Deviation 6.1
|
3.0 Units per liter
Standard Deviation 10.4
|
0.7 Units per liter
Standard Deviation 3.6
|
—
|
—
|
|
Part B: Change From Baseline in ALT, AST and Alk Phos
ALT; Day 15; n=10,5,6,6,6,6
|
-1.3 Units per liter
Standard Deviation 11.9
|
-8.2 Units per liter
Standard Deviation 4.7
|
-5.3 Units per liter
Standard Deviation 8.1
|
-3.8 Units per liter
Standard Deviation 6.7
|
-0.7 Units per liter
Standard Deviation 4.1
|
-0.8 Units per liter
Standard Deviation 3.8
|
—
|
—
|
|
Part B: Change From Baseline in ALT, AST and Alk Phos
AST; Day 15; n=10,5,6,6,6,6
|
0.5 Units per liter
Standard Deviation 5.3
|
-1.6 Units per liter
Standard Deviation 4.2
|
3.2 Units per liter
Standard Deviation 6.7
|
0.5 Units per liter
Standard Deviation 3.3
|
-0.8 Units per liter
Standard Deviation 2.9
|
-0.3 Units per liter
Standard Deviation 3.9
|
—
|
—
|
|
Part B: Change From Baseline in ALT, AST and Alk Phos
AST; Follow-up (Day 25); n=10,6,6,6,6,6
|
-0.4 Units per liter
Standard Deviation 4.0
|
-0.2 Units per liter
Standard Deviation 5.5
|
1.7 Units per liter
Standard Deviation 5.1
|
7.7 Units per liter
Standard Deviation 16.0
|
1.2 Units per liter
Standard Deviation 4.4
|
-1.2 Units per liter
Standard Deviation 4.6
|
—
|
—
|
|
Part B: Change From Baseline in ALT, AST and Alk Phos
Alk Phos; Day 7; n=10,6,6,6,6,6
|
-6.7 Units per liter
Standard Deviation 4.4
|
-7.3 Units per liter
Standard Deviation 9.4
|
-8.7 Units per liter
Standard Deviation 4.9
|
-2.8 Units per liter
Standard Deviation 6.6
|
-10.5 Units per liter
Standard Deviation 5.6
|
-1.8 Units per liter
Standard Deviation 6.1
|
—
|
—
|
|
Part B: Change From Baseline in ALT, AST and Alk Phos
Alk Phos ; Day 15; n=10,5,6,6,6,6
|
-4.3 Units per liter
Standard Deviation 5.9
|
-1.4 Units per liter
Standard Deviation 3.6
|
-5.3 Units per liter
Standard Deviation 6.5
|
-0.5 Units per liter
Standard Deviation 7.5
|
-4.8 Units per liter
Standard Deviation 6.8
|
0.7 Units per liter
Standard Deviation 6.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood samples were collected for analysis of clinical chemistry parameters including bilirubin, creatinine, direct bilirubin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 1 and 3
Bilirubin; Day 3
|
1.2 Micromoles per liter
Standard Deviation 3.3
|
1.0 Micromoles per liter
Standard Deviation 4.2
|
1.2 Micromoles per liter
Standard Deviation 3.0
|
2.2 Micromoles per liter
Standard Deviation 1.9
|
1.6 Micromoles per liter
Standard Deviation 3.4
|
-0.7 Micromoles per liter
Standard Deviation 4.4
|
2.2 Micromoles per liter
Standard Deviation 3.7
|
—
|
|
Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 1 and 3
Creatinine; Day 3
|
-0.7 Micromoles per liter
Standard Deviation 7.0
|
-2.5 Micromoles per liter
Standard Deviation 5.3
|
-2.3 Micromoles per liter
Standard Deviation 8.5
|
1.7 Micromoles per liter
Standard Deviation 8.6
|
0.4 Micromoles per liter
Standard Deviation 11.1
|
1.5 Micromoles per liter
Standard Deviation 5.0
|
-3.0 Micromoles per liter
Standard Deviation 13.4
|
—
|
|
Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 1 and 3
Direct bilirubin; Day 3
|
0.80 Micromoles per liter
Standard Deviation 1.49
|
0.85 Micromoles per liter
Standard Deviation 1.86
|
0.52 Micromoles per liter
Standard Deviation 0.74
|
1.38 Micromoles per liter
Standard Deviation 0.90
|
1.58 Micromoles per liter
Standard Deviation 1.00
|
-1.15 Micromoles per liter
Standard Deviation 1.84
|
-0.14 Micromoles per liter
Standard Deviation 1.00
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Blood samples were collected for analysis of clinical chemistry parameters including bilirubin, creatinine, and direct bilirubin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 2
Bilirubin; Day 3
|
3.5 Micromoles per liter
Standard Deviation 2.1
|
2.0 Micromoles per liter
Standard Deviation 1.4
|
1.5 Micromoles per liter
Standard Deviation 3.4
|
-0.7 Micromoles per liter
Standard Deviation 4.3
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 2
Creatinine; Day 3
|
-8.5 Micromoles per liter
Standard Deviation 7.8
|
-8.0 Micromoles per liter
Standard Deviation 8.5
|
-2.2 Micromoles per liter
Standard Deviation 4.6
|
-5.3 Micromoles per liter
Standard Deviation 4.3
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 2
Direct bilirubin; Day 3
|
0.65 Micromoles per liter
Standard Deviation 0.35
|
0.50 Micromoles per liter
Standard Deviation 0.00
|
0.38 Micromoles per liter
Standard Deviation 0.87
|
-0.10 Micromoles per liter
Standard Deviation 1.33
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected for analysis of hematology parameters including bilirubin, creatinine, and direct bilirubin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin ; Day 15; n=10,5,6,6,6,6
|
1.00 Micromoles per liter
Standard Deviation 0.67
|
1.10 Micromoles per liter
Standard Deviation 0.54
|
0.73 Micromoles per liter
Standard Deviation 0.81
|
1.73 Micromoles per liter
Standard Deviation 0.46
|
0.73 Micromoles per liter
Standard Deviation 1.17
|
0.25 Micromoles per liter
Standard Deviation 1.51
|
—
|
—
|
|
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin; Follow-up(Day 25);n=10,6,6,6,6,6
|
1.06 Micromoles per liter
Standard Deviation 0.62
|
1.10 Micromoles per liter
Standard Deviation 1.05
|
0.95 Micromoles per liter
Standard Deviation 0.87
|
1.78 Micromoles per liter
Standard Deviation 1.06
|
-0.12 Micromoles per liter
Standard Deviation 1.42
|
0.48 Micromoles per liter
Standard Deviation 1.23
|
—
|
—
|
|
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Bilirubin; Follow-up (Day 25);n=10,6,6,6,6,6
|
1.2 Micromoles per liter
Standard Deviation 1.6
|
0.5 Micromoles per liter
Standard Deviation 4.4
|
2.5 Micromoles per liter
Standard Deviation 2.2
|
1.8 Micromoles per liter
Standard Deviation 3.5
|
0.3 Micromoles per liter
Standard Deviation 4.4
|
0.8 Micromoles per liter
Standard Deviation 3.8
|
—
|
—
|
|
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Creatinine ; Day 7; n=10,6,6,6,6,6
|
0.2 Micromoles per liter
Standard Deviation 6.5
|
-5.5 Micromoles per liter
Standard Deviation 14.0
|
-1.3 Micromoles per liter
Standard Deviation 15.7
|
-3.3 Micromoles per liter
Standard Deviation 7.3
|
-13.0 Micromoles per liter
Standard Deviation 9.2
|
-1.0 Micromoles per liter
Standard Deviation 6.7
|
—
|
—
|
|
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Creatinine; Follow-up (Day 25); n=10,6,6,6,6,6
|
3.4 Micromoles per liter
Standard Deviation 6.9
|
-1.0 Micromoles per liter
Standard Deviation 16.6
|
0.8 Micromoles per liter
Standard Deviation 15.0
|
0.5 Micromoles per liter
Standard Deviation 7.1
|
-4.0 Micromoles per liter
Standard Deviation 11.3
|
-1.3 Micromoles per liter
Standard Deviation 5.2
|
—
|
—
|
|
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Bilirubin; Day 7; n=10,6,6,6,6,6
|
2.4 Micromoles per liter
Standard Deviation 1.7
|
2.5 Micromoles per liter
Standard Deviation 1.9
|
3.2 Micromoles per liter
Standard Deviation 2.8
|
2.0 Micromoles per liter
Standard Deviation 1.7
|
2.0 Micromoles per liter
Standard Deviation 2.8
|
2.5 Micromoles per liter
Standard Deviation 4.2
|
—
|
—
|
|
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Bilirubin; Day 15; n=10,5,6,6,6,6
|
1.9 Micromoles per liter
Standard Deviation 2.0
|
1.0 Micromoles per liter
Standard Deviation 2.4
|
2.5 Micromoles per liter
Standard Deviation 1.5
|
1.5 Micromoles per liter
Standard Deviation 1.6
|
2.3 Micromoles per liter
Standard Deviation 2.9
|
2.0 Micromoles per liter
Standard Deviation 3.4
|
—
|
—
|
|
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Creatinine; Day 15; n=10,5,6,6,6,6
|
-3.0 Micromoles per liter
Standard Deviation 5.3
|
2.2 Micromoles per liter
Standard Deviation 12.7
|
-1.0 Micromoles per liter
Standard Deviation 15.3
|
-1.0 Micromoles per liter
Standard Deviation 7.8
|
-9.2 Micromoles per liter
Standard Deviation 13.2
|
-2.7 Micromoles per liter
Standard Deviation 4.5
|
—
|
—
|
|
Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin
Direct bilirubin ; Day 7; n=10,6,6,6,6,6
|
1.31 Micromoles per liter
Standard Deviation 0.43
|
1.30 Micromoles per liter
Standard Deviation 0.59
|
1.32 Micromoles per liter
Standard Deviation 1.22
|
1.22 Micromoles per liter
Standard Deviation 0.64
|
0.48 Micromoles per liter
Standard Deviation 1.15
|
0.63 Micromoles per liter
Standard Deviation 1.53
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood samples were collected for analysis of clinical chemistry parameters including Calcium, Glucose, Potassium, Sodium, Urea. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 1 and 3
Glucose; Day 3
|
0.01 Millimoles per liter
Standard Deviation 0.69
|
-0.03 Millimoles per liter
Standard Deviation 0.27
|
0.25 Millimoles per liter
Standard Deviation 0.82
|
0.22 Millimoles per liter
Standard Deviation 0.36
|
-0.32 Millimoles per liter
Standard Deviation 1.32
|
-0.23 Millimoles per liter
Standard Deviation 0.64
|
0.22 Millimoles per liter
Standard Deviation 0.94
|
—
|
|
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 1 and 3
Potassium; Day 3
|
-0.04 Millimoles per liter
Standard Deviation 0.28
|
0.05 Millimoles per liter
Standard Deviation 0.30
|
0.13 Millimoles per liter
Standard Deviation 0.35
|
0.10 Millimoles per liter
Standard Deviation 0.23
|
-0.08 Millimoles per liter
Standard Deviation 0.16
|
-0.03 Millimoles per liter
Standard Deviation 0.27
|
0.16 Millimoles per liter
Standard Deviation 0.17
|
—
|
|
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 1 and 3
Sodium; Day 3
|
-2.5 Millimoles per liter
Standard Deviation 2.2
|
-2.7 Millimoles per liter
Standard Deviation 2.1
|
-2.3 Millimoles per liter
Standard Deviation 3.0
|
-1.8 Millimoles per liter
Standard Deviation 1.5
|
-2.0 Millimoles per liter
Standard Deviation 1.9
|
-1.0 Millimoles per liter
Standard Deviation 2.6
|
1.0 Millimoles per liter
Standard Deviation 1.0
|
—
|
|
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 1 and 3
Urea; Day 3
|
-0.43 Millimoles per liter
Standard Deviation 1.11
|
-0.62 Millimoles per liter
Standard Deviation 0.74
|
-0.68 Millimoles per liter
Standard Deviation 1.39
|
-0.13 Millimoles per liter
Standard Deviation 1.22
|
-0.14 Millimoles per liter
Standard Deviation 0.80
|
-0.55 Millimoles per liter
Standard Deviation 1.20
|
-0.48 Millimoles per liter
Standard Deviation 0.57
|
—
|
|
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 1 and 3
Calcium; Day 3
|
-0.049 Millimoles per liter
Standard Deviation 0.108
|
-0.005 Millimoles per liter
Standard Deviation 0.134
|
-0.075 Millimoles per liter
Standard Deviation 0.107
|
-0.060 Millimoles per liter
Standard Deviation 0.145
|
-0.054 Millimoles per liter
Standard Deviation 0.152
|
-0.063 Millimoles per liter
Standard Deviation 0.038
|
-0.124 Millimoles per liter
Standard Deviation 0.067
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Blood samples were collected for analysis of clinical chemistry parameters including Calcium, Glucose, Potassium, Sodium, Urea. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 2
Glucose; Day 3
|
0.35 Millimoles per liter
Standard Deviation 0.21
|
0.30 Millimoles per liter
Standard Deviation 0.14
|
-0.45 Millimoles per liter
Standard Deviation 0.49
|
-0.55 Millimoles per liter
Standard Deviation 0.52
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 2
Potassium; Day 3
|
0.05 Millimoles per liter
Standard Deviation 0.07
|
0.05 Millimoles per liter
Standard Deviation 0.07
|
-0.17 Millimoles per liter
Standard Deviation 0.27
|
-0.13 Millimoles per liter
Standard Deviation 0.29
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 2
Sodium; Day 3
|
0.0 Millimoles per liter
Standard Deviation 0.0
|
1.0 Millimoles per liter
Standard Deviation 1.4
|
0.7 Millimoles per liter
Standard Deviation 1.2
|
0.5 Millimoles per liter
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 2
Calcium; Day 3
|
-0.075 Millimoles per liter
Standard Deviation 0.078
|
-0.110 Millimoles per liter
Standard Deviation 0.071
|
0.022 Millimoles per liter
Standard Deviation 0.120
|
-0.037 Millimoles per liter
Standard Deviation 0.105
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 2
Urea; Day 3
|
-1.30 Millimoles per liter
Standard Deviation 0.14
|
-1.00 Millimoles per liter
Standard Deviation 0.57
|
0.37 Millimoles per liter
Standard Deviation 1.15
|
-0.03 Millimoles per liter
Standard Deviation 1.32
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected for analysis of hematology parameters including Calcium, Glucose, Potassium, Sodium, Urea. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Calcium; Day 15; n=10,5,6,6,6,6
|
0.026 Millimoles per liter
Standard Deviation 0.142
|
0.124 Millimoles per liter
Standard Deviation 0.093
|
0.167 Millimoles per liter
Standard Deviation 0.044
|
0.073 Millimoles per liter
Standard Deviation 0.026
|
0.052 Millimoles per liter
Standard Deviation 0.098
|
-0.032 Millimoles per liter
Standard Deviation 0.138
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Calcium; Follow-up (Day 25); n=10,6,6,6,6,6
|
0.049 Millimoles per liter
Standard Deviation 0.177
|
0.160 Millimoles per liter
Standard Deviation 0.067
|
0.157 Millimoles per liter
Standard Deviation 0.061
|
0.100 Millimoles per liter
Standard Deviation 0.059
|
-0.023 Millimoles per liter
Standard Deviation 0.080
|
-0.005 Millimoles per liter
Standard Deviation 0.099
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Calcium; Day 7; n=10,6,6,6,6,6
|
-0.001 Millimoles per liter
Standard Deviation 0.086
|
0.040 Millimoles per liter
Standard Deviation 0.065
|
0.108 Millimoles per liter
Standard Deviation 0.027
|
0.050 Millimoles per liter
Standard Deviation 0.055
|
-0.045 Millimoles per liter
Standard Deviation 0.106
|
-0.035 Millimoles per liter
Standard Deviation 0.100
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Glucose; Day 7; n=10,6,6,6,6,6
|
-0.16 Millimoles per liter
Standard Deviation 0.80
|
-0.78 Millimoles per liter
Standard Deviation 0.69
|
-0.05 Millimoles per liter
Standard Deviation 0.45
|
-0.17 Millimoles per liter
Standard Deviation 0.46
|
-0.47 Millimoles per liter
Standard Deviation 0.46
|
-0.33 Millimoles per liter
Standard Deviation 0.47
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Glucose; Day 15; n=10,5,6,6,6,6
|
-0.37 Millimoles per liter
Standard Deviation 0.81
|
-0.70 Millimoles per liter
Standard Deviation 0.62
|
-0.17 Millimoles per liter
Standard Deviation 0.52
|
-0.72 Millimoles per liter
Standard Deviation 0.35
|
-1.02 Millimoles per liter
Standard Deviation 0.55
|
-0.40 Millimoles per liter
Standard Deviation 0.40
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Glucose; Follow-up (Day 25); n=10,6,6,6,6,6
|
0.21 Millimoles per liter
Standard Deviation 0.96
|
-0.03 Millimoles per liter
Standard Deviation 1.00
|
-0.30 Millimoles per liter
Standard Deviation 0.67
|
-0.08 Millimoles per liter
Standard Deviation 0.38
|
-0.08 Millimoles per liter
Standard Deviation 1.21
|
-0.12 Millimoles per liter
Standard Deviation 0.98
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Potassium; Day 7; n=10,6,6,6,6,6
|
0.22 Millimoles per liter
Standard Deviation 0.64
|
-0.17 Millimoles per liter
Standard Deviation 0.39
|
0.38 Millimoles per liter
Standard Deviation 0.42
|
0.57 Millimoles per liter
Standard Deviation 0.21
|
0.15 Millimoles per liter
Standard Deviation 0.74
|
-0.05 Millimoles per liter
Standard Deviation 0.23
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Potassium; Day 15; n=10,5,6,6,6,6
|
-0.06 Millimoles per liter
Standard Deviation 0.33
|
-0.06 Millimoles per liter
Standard Deviation 0.54
|
0.47 Millimoles per liter
Standard Deviation 0.37
|
0.18 Millimoles per liter
Standard Deviation 0.15
|
-0.02 Millimoles per liter
Standard Deviation 0.31
|
0.07 Millimoles per liter
Standard Deviation 0.36
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Potassium; Follow-up (Day 25); n=10,6,6,6,6,6
|
0.04 Millimoles per liter
Standard Deviation 0.41
|
0.03 Millimoles per liter
Standard Deviation 0.43
|
0.23 Millimoles per liter
Standard Deviation 0.23
|
-0.07 Millimoles per liter
Standard Deviation 0.41
|
-0.10 Millimoles per liter
Standard Deviation 0.32
|
0.00 Millimoles per liter
Standard Deviation 0.28
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Sodium; Day 7; n=10,6,6,6,6,6
|
-1.8 Millimoles per liter
Standard Deviation 2.7
|
-2.7 Millimoles per liter
Standard Deviation 2.0
|
-0.3 Millimoles per liter
Standard Deviation 1.6
|
-0.8 Millimoles per liter
Standard Deviation 2.6
|
-2.3 Millimoles per liter
Standard Deviation 3.0
|
-0.3 Millimoles per liter
Standard Deviation 2.1
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Sodium; Day 15; n=10,5,6,6,6,6
|
-1.8 Millimoles per liter
Standard Deviation 2.7
|
-2.0 Millimoles per liter
Standard Deviation 2.9
|
-0.5 Millimoles per liter
Standard Deviation 0.8
|
1.0 Millimoles per liter
Standard Deviation 2.7
|
1.8 Millimoles per liter
Standard Deviation 3.4
|
0.3 Millimoles per liter
Standard Deviation 2.3
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Sodium; Follow-up (Day 25); n=10,6,6,6,6,6
|
-1.6 Millimoles per liter
Standard Deviation 2.8
|
-2.3 Millimoles per liter
Standard Deviation 2.4
|
-0.5 Millimoles per liter
Standard Deviation 1.2
|
0.8 Millimoles per liter
Standard Deviation 2.2
|
0.7 Millimoles per liter
Standard Deviation 3.3
|
0.2 Millimoles per liter
Standard Deviation 0.8
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Urea; Day 7; n=10,6,6,6,6,6
|
-0.84 Millimoles per liter
Standard Deviation 0.88
|
-0.52 Millimoles per liter
Standard Deviation 0.75
|
-2.58 Millimoles per liter
Standard Deviation 2.10
|
-0.43 Millimoles per liter
Standard Deviation 0.42
|
-1.18 Millimoles per liter
Standard Deviation 1.28
|
-0.20 Millimoles per liter
Standard Deviation 0.75
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Urea; Day 15; n=10,5,6,6,6,6
|
-1.56 Millimoles per liter
Standard Deviation 1.04
|
-0.88 Millimoles per liter
Standard Deviation 0.79
|
-2.82 Millimoles per liter
Standard Deviation 2.01
|
-1.17 Millimoles per liter
Standard Deviation 0.31
|
-1.40 Millimoles per liter
Standard Deviation 1.21
|
-1.25 Millimoles per liter
Standard Deviation 0.78
|
—
|
—
|
|
Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea
Urea; Follow-up (Day 25); n=10,6,6,6,6,6
|
0.48 Millimoles per liter
Standard Deviation 1.04
|
0.50 Millimoles per liter
Standard Deviation 1.69
|
-0.27 Millimoles per liter
Standard Deviation 0.91
|
-0.40 Millimoles per liter
Standard Deviation 1.39
|
-1.10 Millimoles per liter
Standard Deviation 1.67
|
-0.03 Millimoles per liter
Standard Deviation 1.03
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Blood samples were collected for analysis of clinical chemistry parameters including albumin, and total protein. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Albumin and Total Protein in Cohort 1 and 3
Albumin; Day 3
|
-3.1 Grams per liter
Standard Deviation 3.5
|
-1.8 Grams per liter
Standard Deviation 4.8
|
-3.5 Grams per liter
Standard Deviation 4.3
|
-3.2 Grams per liter
Standard Deviation 3.1
|
-4.8 Grams per liter
Standard Deviation 3.8
|
-2.8 Grams per liter
Standard Deviation 2.2
|
-3.8 Grams per liter
Standard Deviation 2.8
|
—
|
|
Part A: Change From Baseline in Albumin and Total Protein in Cohort 1 and 3
Total Protein; Day 3
|
-3.5 Grams per liter
Standard Deviation 5.8
|
-2.5 Grams per liter
Standard Deviation 6.9
|
-5.0 Grams per liter
Standard Deviation 7.4
|
-3.3 Grams per liter
Standard Deviation 5.3
|
-6.2 Grams per liter
Standard Deviation 7.1
|
-2.0 Grams per liter
Standard Deviation 3.6
|
-2.6 Grams per liter
Standard Deviation 3.4
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Blood samples were collected for analysis of clinical chemistry parameters including albumin and total protein. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Change From Baseline in Albumin and Total Protein in Cohort 2
Total Protein; Day 3
|
-2.5 Grams per liter
Standard Deviation 0.7
|
-4.5 Grams per liter
Standard Deviation 2.1
|
-1.5 Grams per liter
Standard Deviation 5.1
|
-3.8 Grams per liter
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
|
Part A: Change From Baseline in Albumin and Total Protein in Cohort 2
Albumin; Day 3
|
-1.0 Grams per liter
Standard Deviation 0.0
|
-2.0 Grams per liter
Standard Deviation 0.0
|
-1.2 Grams per liter
Standard Deviation 2.7
|
-1.7 Grams per liter
Standard Deviation 2.9
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected for analysis of hematology parameters including albumin and total protein. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline in Albumin, Total Protein
Albumin; Day 7; n=10,6,6,6,6,6
|
-2.5 Grams per liter
Standard Deviation 1.9
|
-2.3 Grams per liter
Standard Deviation 1.4
|
-2.2 Grams per liter
Standard Deviation 0.8
|
-3.3 Grams per liter
Standard Deviation 1.9
|
-3.7 Grams per liter
Standard Deviation 1.4
|
-0.8 Grams per liter
Standard Deviation 3.1
|
—
|
—
|
|
Part B: Change From Baseline in Albumin, Total Protein
Albumin; Day 15; n=10,5,6,6,6,6
|
-2.2 Grams per liter
Standard Deviation 2.6
|
-0.4 Grams per liter
Standard Deviation 2.2
|
0.2 Grams per liter
Standard Deviation 1.5
|
-2.5 Grams per liter
Standard Deviation 2.3
|
-0.7 Grams per liter
Standard Deviation 1.2
|
-1.0 Grams per liter
Standard Deviation 3.5
|
—
|
—
|
|
Part B: Change From Baseline in Albumin, Total Protein
Albumin; Follow-up (Day 25);n=10,6,6,6,6,6
|
-0.7 Grams per liter
Standard Deviation 2.5
|
-0.3 Grams per liter
Standard Deviation 3.3
|
1.2 Grams per liter
Standard Deviation 1.0
|
0.2 Grams per liter
Standard Deviation 3.6
|
-1.7 Grams per liter
Standard Deviation 1.4
|
-0.5 Grams per liter
Standard Deviation 2.9
|
—
|
—
|
|
Part B: Change From Baseline in Albumin, Total Protein
Total Protein; Day 7; n=10,6,6,6,6,6
|
-3.0 Grams per liter
Standard Deviation 3.2
|
-2.5 Grams per liter
Standard Deviation 2.1
|
-4.0 Grams per liter
Standard Deviation 2.3
|
-1.8 Grams per liter
Standard Deviation 2.1
|
-4.5 Grams per liter
Standard Deviation 2.3
|
-1.2 Grams per liter
Standard Deviation 4.5
|
—
|
—
|
|
Part B: Change From Baseline in Albumin, Total Protein
Total Protein; Day 15; n=10,5,6,6,6,6
|
-2.9 Grams per liter
Standard Deviation 3.7
|
0.2 Grams per liter
Standard Deviation 4.1
|
-0.3 Grams per liter
Standard Deviation 3.1
|
-1.3 Grams per liter
Standard Deviation 3.0
|
-1.0 Grams per liter
Standard Deviation 2.8
|
0.2 Grams per liter
Standard Deviation 5.4
|
—
|
—
|
|
Part B: Change From Baseline in Albumin, Total Protein
Total Protein;Follow-up (Day 25); n=10,6,6,6,6,6
|
-1.4 Grams per liter
Standard Deviation 4.8
|
0.8 Grams per liter
Standard Deviation 4.9
|
0.5 Grams per liter
Standard Deviation 1.9
|
2.0 Grams per liter
Standard Deviation 4.4
|
-2.2 Grams per liter
Standard Deviation 2.5
|
-1.3 Grams per liter
Standard Deviation 4.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day-1) and Day 3Population: Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.
Urine samples were collected from participants for analysis of specific gravity of urine. Urine parameters including bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, potential of hydrogen (pH), protein, specific gravity and Urobilinogen were analyzed by dipstick method. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable).
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=12 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Bilirubin; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Glucose; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Leukocyte esterase; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
pH; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Urobilinogen; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Bilirubin; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Glucose; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Ketones; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Ketones; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Leukocyte esterase; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Nitrite; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Nitrite; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Occult blood; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Occult blood; Day 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
pH; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Protein; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Protein; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Specific gravity; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Specific gravity; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3
Urobilinogen; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 3Population: Safety population
Urine samples were collected from participants for analysis of specific gravity of urine. Urine parameters including bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, potential of hydrogen (pH), protein, specific gravity and Urobilinogen were analyzed by dipstick method. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable).
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=2 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=2 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Bilirubin; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Bilirubin; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Ketones; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Specific gravity; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Specific gravity; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Urobilinogen; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Urobilinogen; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Leukocyte esterase; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Nitrite; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Nitrite; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Occult blood; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Occult blood; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
pH; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
pH; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Protein; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Protein; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Glucose; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Glucose; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Ketones; Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2
Leukocyte esterase; Baseline (Day -1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)Population: Safety population
Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=10 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Bilirubin; Follow-up (Day 25)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Ketones; Baseline (Day -2)
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Ketones; Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Leukocyte esterase; Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Protein; Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Urobilinogen; Baseline (Day -2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Glucose; Baseline (Day -2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Glucose; Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Bilirubin; Baseline (Day -2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Bilirubin; Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Bilirubin; Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Glucose; Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Glucose; Follow-up (Day 25)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Ketones; Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Ketones; Follow-up (Day 25)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Leukocyte esterase; Baseline (Day -2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Leukocyte esterase; Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Leukocyte esterase; Follow-up (Day 25)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Nitrite; Baseline (Day -2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Nitrite; Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Nitrite; Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Nitrite; Follow-up (Day 25)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Occult blood; Baseline (Day -2)
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Occult blood; Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Occult blood; Day 15
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Occult blood; Follow-up (Day 25)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
pH; Baseline (Day -2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
pH; Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
pH; Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
pH; Follow-up (Day 25)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Protein; Baseline (Day -2)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Protein; Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Protein; Follow-up (Day 25)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Specific gravity; Baseline (Day -2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Specific gravity; Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Specific gravity; Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Specific gravity; Follow-up (Day 25)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Urobilinogen; Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Urobilinogen; Day 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Abnormal Findings for Urine Parameters
Urobilinogen; Follow-up (Day 25)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dosePopulation: Pharmacokinetic Parameter Population comprised of all randomized participants who received at least one dose of active treatment and who had GSK3352589 Pharmacokinetic parameter estimates from any portion of the study.
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods. The PK Parameter population comprised of all randomized participants who received at least one dose of active treatment and who had GSK3352589 Pharmacokinetic parameter estimates from any portion of the study.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=5 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=6 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Non-zero Concentration (AUC [0-t]) Following Single Dose Administration of GSK3352589
|
0.8452 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 75.5
|
1.306 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 66.2
|
2.480 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 49.4
|
4.630 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 63.9
|
2.771 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 38.9
|
2.030 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 24.4
|
9.416 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 119.1
|
11.67 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 124.7
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dosePopulation: Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed.
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=5 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=5 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=5 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=3 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=5 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=6 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
n=2 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK3352589
|
0.9652 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 83.7
|
1.446 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 73.0
|
2.738 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 46.3
|
5.031 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 63.6
|
3.648 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 53.3
|
2.372 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 27.8
|
10.75 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 119.1
|
17.49 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 1.9
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dosePopulation: Pharmacokinetic Parameter Population
Blood samples were collected from participants for pharmacokinetic analysis including Cmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=5 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=6 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of GSK3352589
|
0.2339 Nanogram per milliliter
Geometric Coefficient of Variation 74.1
|
0.2919 Nanogram per milliliter
Geometric Coefficient of Variation 58.6
|
0.5541 Nanogram per milliliter
Geometric Coefficient of Variation 40.0
|
0.7318 Nanogram per milliliter
Geometric Coefficient of Variation 65.3
|
0.5397 Nanogram per milliliter
Geometric Coefficient of Variation 38.6
|
0.4317 Nanogram per milliliter
Geometric Coefficient of Variation 15.2
|
1.325 Nanogram per milliliter
Geometric Coefficient of Variation 111.6
|
1.157 Nanogram per milliliter
Geometric Coefficient of Variation 72.5
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dosePopulation: Pharmacokinetic Parameter Population
Blood samples were collected from participants for pharmacokinetic analysis including Tmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=5 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=6 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=6 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
n=5 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Time to Reach Cmax (Tmax) Following Single Dose Administration of GSK3352589
|
1.25 Hours
Interval 0.5 to 2.0
|
1.50 Hours
Interval 1.0 to 3.0
|
1.00 Hours
Interval 0.5 to 2.0
|
1.50 Hours
Interval 1.0 to 4.0
|
1.25 Hours
Interval 1.0 to 2.0
|
0.750 Hours
Interval 0.5 to 2.0
|
1.25 Hours
Interval 0.5 to 3.0
|
1.00 Hours
Interval 0.5 to 4.0
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dosePopulation: Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed.
Blood samples were collected from participants for pharmacokinetic analysis including t1/2 following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=5 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=5 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=5 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=3 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
n=5 Participants
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
n=6 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
n=3 Participants
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Terminal Elimination Half-life (t1/2) Following Single Dose Administration of GSK3352589
|
5.54 Hours
Geometric Coefficient of Variation 83.1
|
7.83 Hours
Geometric Coefficient of Variation 65.1
|
17.1 Hours
Geometric Coefficient of Variation 32.4
|
17.0 Hours
Geometric Coefficient of Variation 11.8
|
19.2 Hours
Geometric Coefficient of Variation 33.7
|
20.5 Hours
Geometric Coefficient of Variation 19.7
|
16.1 Hours
Geometric Coefficient of Variation 58.9
|
14.4 Hours
Geometric Coefficient of Variation 39.7
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dosePopulation: Pharmacokinetic Parameter Population
Blood samples were collected from participants for pharmacokinetic analysis following administration of GSK3352589 in fasted and fed condition to assess the effect of food on pharmacokinetics of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Cmax Following Single Dose Administration of GSK3352589-Food Effect
|
0.5397 Nanogram per milliliter
Geometric Coefficient of Variation 38.6
|
0.4317 Nanogram per milliliter
Geometric Coefficient of Variation 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dosePopulation: Pharmacokinetic Parameter Population
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following administration of GSK3352589 in fasted and fed condition to assess the effect of food on pharmacokinetics of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: AUC (0-t) Following Single Dose Administration of GSK3352589- Food Effect
|
1.019 Hours*Nanogram per milliliter
Standard Error 0.1287
|
0.7081 Hours*Nanogram per milliliter
Standard Error 0.1287
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dosePopulation: Pharmacokinetic Parameter Population
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following administration of GSK3352589 in fasted and fed condition to assess the effect of food on pharmacokinetics of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: AUC (0-infinity) Following Single Dose Administration of GSK3352589- Food Effect
|
1.294 Hours*Nanogram per milliliter
Standard Error 0.2105
|
0.8636 Hours*Nanogram per milliliter
Standard Error 0.1630
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: AUC (0-t) Following Repeat Dose Administration of GSK3352589
Day 1; n=6, 6, 6, 6, 6
|
0.4479 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 89.6
|
0.4647 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 75.1
|
2.167 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 41.2
|
3.459 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 84.6
|
2.934 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 90.0
|
—
|
—
|
—
|
|
Part B: AUC (0-t) Following Repeat Dose Administration of GSK3352589
Day 14; n=5, 6, 6, 6, 6
|
0.7147 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 84.9
|
0.7176 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 53.4
|
3.763 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 21.5
|
6.121 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 35.0
|
8.061 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 53.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-24) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours Post-dose (AUC [0-24]) Following Repeat Dose Administration of GSK3352589
Day 1; n=6, 6, 6, 6, 6
|
1.389 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 58.6
|
1.641 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 51.5
|
7.285 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 40.6
|
11.41 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 65.5
|
12.31 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 73.3
|
—
|
—
|
—
|
|
Part B: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours Post-dose (AUC [0-24]) Following Repeat Dose Administration of GSK3352589
Day 14; n=5, 6, 6, 6, 6
|
1.988 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 62.5
|
1.970 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 44.1
|
9.383 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 23.2
|
15.73 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 33.8
|
24.11 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 45.9
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK3352589
Day 1; n=6, 6, 6, 6, 6
|
0.5028 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 87.9
|
0.5468 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 72.9
|
2.522 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 43.4
|
4.055 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 80.0
|
3.673 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 81.9
|
—
|
—
|
—
|
|
Part B: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK3352589
Day 14; n=5, 6, 6, 6, 6
|
0.8303 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 82.7
|
0.8417 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 53.8
|
4.421 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 22.1
|
7.242 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 34.9
|
9.914 Hour*Nanogram per milliliter
Geometric Coefficient of Variation 54.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected from participants for pharmacokinetic analysis including Cmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Cmax Following Repeat Dose Administration of GSK3352589
Day 1; n=6, 6, 6, 6, 6
|
0.1308 Nanogram per milliliter
Geometric Coefficient of Variation 93.0
|
0.1394 Nanogram per milliliter
Geometric Coefficient of Variation 51.2
|
0.5255 Nanogram per milliliter
Geometric Coefficient of Variation 17.9
|
0.8191 Nanogram per milliliter
Geometric Coefficient of Variation 78.5
|
0.6607 Nanogram per milliliter
Geometric Coefficient of Variation 67.4
|
—
|
—
|
—
|
|
Part B: Cmax Following Repeat Dose Administration of GSK3352589
Day 14; n=5, 6, 6, 6, 6
|
0.1655 Nanogram per milliliter
Geometric Coefficient of Variation 74.3
|
0.1919 Nanogram per milliliter
Geometric Coefficient of Variation 31.3
|
0.7149 Nanogram per milliliter
Geometric Coefficient of Variation 26.4
|
1.260 Nanogram per milliliter
Geometric Coefficient of Variation 36.7
|
1.526 Nanogram per milliliter
Geometric Coefficient of Variation 43.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14Population: Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).
Blood samples were collected from participants for pharmacokinetic analysis including Tmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.
Outcome measures
| Measure |
Part A: Cohort 1: Placebo
n=6 Participants
Participants received placebo tablet matching GSK3352589 orally in one of the Periods of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 Participants
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 Participants
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 Participants
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=6 Participants
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part B: GSK3352589 200 mg BID
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
Part A:Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Cohort 3: GSK3352589 400 mg
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Tmax Following Repeat Dose Administration of GSK3352589
Day 14; n=5, 6, 6, 6, 6
|
0.500 Hours
Interval 0.5 to 3.0
|
0.500 Hours
Interval 0.5 to 3.0
|
1.50 Hours
Interval 0.5 to 4.0
|
1.75 Hours
Interval 0.5 to 2.5
|
0.500 Hours
Interval 0.5 to 4.0
|
—
|
—
|
—
|
|
Part B: Tmax Following Repeat Dose Administration of GSK3352589
Day 1; n=6, 6, 6, 6, 6
|
0.767 Hours
Interval 0.5 to 3.0
|
1.00 Hours
Interval 0.5 to 3.0
|
1.00 Hours
Interval 0.5 to 4.0
|
1.50 Hours
Interval 0.5 to 3.0
|
0.750 Hours
Interval 0.5 to 1.0
|
—
|
—
|
—
|
Adverse Events
Part A: Cohort 1: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Cohort 1: GSK3352589 2 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A: Cohort 1: GSK3352589 5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Cohort 1: GSK3352589 15 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Cohort 1: GSK3352589 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Cohort 2: Fasted Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Cohort 2: Fed Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 2: GSK3352589 Fed 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Cohort 2: GSK3352589 Fasted 25 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Cohort 3: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Cohort 3: GSK3352589 150 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Cohort 3: GSK3352589 400 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Placebo BID
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Part B: GSK3352589 5 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: GSK3352589 15 mg BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: GSK3352589 50 mg BID
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: GSK3352589 100 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: GSK3352589 200 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Cohort 1: Placebo
n=8 participants at risk
Participants received placebo tablet matching GSK3352589 orally in each Period of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 participants at risk
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 participants at risk
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 participants at risk
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 participants at risk
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part A: Cohort 2: Fasted Placebo
n=2 participants at risk
Participants received placebo tablet matching GSK3352589 without food in Period 1 of Cohort 2 in Part A of the study.
|
Part A: Cohort 2: Fed Placebo
n=2 participants at risk
Participants received placebo tablet matching GSK3352589 with food in Period 2 of Cohort 2 in Part A of the study.
|
Part A: Cohort 2: GSK3352589 Fed 25 mg
n=6 participants at risk
Participants received GSK3352589 25 mg tablet with food in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 2: GSK3352589 Fasted 25 mg
n=6 participants at risk
Participants received GSK3352589 25 mg tablet without food in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 3: Placebo
n=4 participants at risk
Participants received placebo tablet matching GSK3352589 in each Period of Cohort 3 in Part A of the study.
|
Part A: Cohort 3: GSK3352589 150 mg
n=6 participants at risk
Participants received GSK3352589 150 mg tablet in Period 1 of Cohort 3 in Part A of the study.
|
Part A: Cohort 3: GSK3352589 400 mg
n=5 participants at risk
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Part B: Placebo BID
n=10 participants at risk
Participants received repeat oral doses of placebo BID (twice a day) tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 5 mg BID
n=6 participants at risk
Participants received repeat oral doses of GSK3352589 5 mg BID tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 15 mg BID
n=6 participants at risk
Participants received repeat oral doses of GSK3352589 15 mg BID tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 50 mg BID
n=6 participants at risk
Participants received repeat oral doses of GSK3352589 50 mg BID tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 100 mg BID
n=6 participants at risk
Participants received repeat doses of GSK3352589 100 mg BID administered for 14 days in Part B of the study.
|
Part B: GSK3352589 200 mg BID
n=6 participants at risk
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
Other adverse events
| Measure |
Part A: Cohort 1: Placebo
n=8 participants at risk
Participants received placebo tablet matching GSK3352589 orally in each Period of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 2 mg
n=6 participants at risk
Participants received GSK3352589 2 mg tablet orally in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 5 mg
n=6 participants at risk
Participants received GSK3352589 5 mg tablet orally in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 15 mg
n=6 participants at risk
Participants received GSK3352589 15 mg tablet orally in Period 3 of Cohort 1 in Part A of the study.
|
Part A: Cohort 1: GSK3352589 50 mg
n=5 participants at risk
Participants received GSK3352589 50 mg tablet in Period 4 of Cohort 1 in Part A of the study.
|
Part A: Cohort 2: Fasted Placebo
n=2 participants at risk
Participants received placebo tablet matching GSK3352589 without food in Period 1 of Cohort 2 in Part A of the study.
|
Part A: Cohort 2: Fed Placebo
n=2 participants at risk
Participants received placebo tablet matching GSK3352589 with food in Period 2 of Cohort 2 in Part A of the study.
|
Part A: Cohort 2: GSK3352589 Fed 25 mg
n=6 participants at risk
Participants received GSK3352589 25 mg tablet with food in Period 2 of Cohort 1 in Part A of the study.
|
Part A: Cohort 2: GSK3352589 Fasted 25 mg
n=6 participants at risk
Participants received GSK3352589 25 mg tablet without food in Period 1 of Cohort 1 in Part A of the study.
|
Part A: Cohort 3: Placebo
n=4 participants at risk
Participants received placebo tablet matching GSK3352589 in each Period of Cohort 3 in Part A of the study.
|
Part A: Cohort 3: GSK3352589 150 mg
n=6 participants at risk
Participants received GSK3352589 150 mg tablet in Period 1 of Cohort 3 in Part A of the study.
|
Part A: Cohort 3: GSK3352589 400 mg
n=5 participants at risk
Participants received GSK3352589 400 mg tablet in Period 2 of Cohort 3 in Part A of the study.
|
Part B: Placebo BID
n=10 participants at risk
Participants received repeat oral doses of placebo BID (twice a day) tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 5 mg BID
n=6 participants at risk
Participants received repeat oral doses of GSK3352589 5 mg BID tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 15 mg BID
n=6 participants at risk
Participants received repeat oral doses of GSK3352589 15 mg BID tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 50 mg BID
n=6 participants at risk
Participants received repeat oral doses of GSK3352589 50 mg BID tablet administered for 14 days in Part B of the study.
|
Part B: GSK3352589 100 mg BID
n=6 participants at risk
Participants received repeat doses of GSK3352589 100 mg BID administered for 14 days in Part B of the study.
|
Part B: GSK3352589 200 mg BID
n=6 participants at risk
Participants received repeat doses of GSK3352589 200 mg BID administered for 14 days in Part B of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Weight decreased
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
25.0%
1/4 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
40.0%
4/10 • Number of events 6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
50.0%
1/2 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
20.0%
1/5 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Catheter site bruise
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Catheter site pain
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
20.0%
2/10 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 3 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Hunger
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
20.0%
2/10 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
83.3%
5/6 • Number of events 5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Malaise
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
25.0%
1/4 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
20.0%
2/10 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Infections and infestations
Pharyngitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
25.0%
1/4 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
25.0%
1/4 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Immune system disorders
Food allergy
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
25.0%
1/4 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Vascular disorders
Flushing
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
33.3%
2/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Catheter site mass
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
10.0%
1/10 • Number of events 1 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/8 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/4 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/5 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/10 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
16.7%
1/6 • Number of events 2 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
0.00%
0/6 • Serious adverse events (SAEs) and non-SAEs were collected up to 64 days in Cohort 1, up to 30 days in Cohort 2, up to 30 days in Cohort 3 each in Part A of the study and up to 25 days in Part B of the study.
SAEs and non-SAEs were collected using Safety Population.
|
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