Trial Outcomes & Findings for First Time in Human (FTIH) Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of GSK3439171A in Healthy Subjects and to Assess Food Effect (NCT NCT03627494)
NCT ID: NCT03627494
Last Updated: 2020-07-10
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
66 participants
Primary outcome timeframe
Up to Day 40
Results posted on
2020-07-10
Participant Flow
This was a 3 part study conducted at a single center in the United States where, Part A is a single oral dose, dose-rising, 3 period crossover study; Part B is a repeat oral dosing, dose escalation study and Part C is a crossover study where a single dose was administered in fasted or fed conditions.
A total of 66 participants were enrolled in Part A (18 participants), Part B (36 participants) and Part C (12 participants).
Participant milestones
| Measure |
GSK3439171A 5 mg/Placebo/GSK3439171A 30 mg
Participants were administered a single oral dose of 5 milligrams (mg) GSK3439171A on Day 1 of treatment period 1, followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Placebo/ GSK3439171A 10 mg/GSK3439171A 30 mg
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A in treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 5 mg/GSK3439171A 10 mg/Placebo
Participants were administered a single oral dose of 5 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg/GSK3439171A 120 mg/Placebo
Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants then administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Placebo/ GSK3439171A 120 mg/GSK3439171A 180 mg
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg/Placebo/GSK3439171A 180 mg
Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Placebo
Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 5 mg
Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 11 mg
Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 40 mg
Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg Fasted/GSK3439171A 60 mg Fed
Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg Fed/GSK3439171A 60 mg Fasted
Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state. All participants were followed up for 14 days after the administration of last dose of study treatment.
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Part A Period 1 (4 Days)
STARTED
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3
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3
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3
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3
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3
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Part A Period 1 (4 Days)
COMPLETED
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3
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3
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3
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3
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3
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3
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0
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0
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0
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Part A Period 1 (4 Days)
NOT COMPLETED
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Part A Washout 1 (7 Days)
STARTED
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3
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3
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3
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3
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Part A Washout 1 (7 Days)
COMPLETED
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3
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3
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3
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3
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3
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3
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0
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Part A Washout 1 (7 Days)
NOT COMPLETED
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Part A Period 2 (4 Days)
STARTED
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Part A Period 2 (4 Days)
COMPLETED
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3
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3
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3
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3
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3
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3
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Part A Period 2 (4 Days)
NOT COMPLETED
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Part A Washout 2 (7 Days)
STARTED
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3
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3
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3
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3
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3
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3
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Part A Washout 2 (7 Days)
COMPLETED
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2
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3
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2
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3
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3
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3
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0
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Part A Washout 2 (7 Days)
NOT COMPLETED
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1
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1
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Part A Period3(4days)+Follow-up(14days)
STARTED
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2
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3
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3
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Part A Period3(4days)+Follow-up(14days)
COMPLETED
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2
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3
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3
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3
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3
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Part A Period3(4days)+Follow-up(14days)
NOT COMPLETED
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Part B (Maximum of 34 Days)
STARTED
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9
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Part B (Maximum of 34 Days)
COMPLETED
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0
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9
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9
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7
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Part B (Maximum of 34 Days)
NOT COMPLETED
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2
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Part C Period 1 (4 Days)
STARTED
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6
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6
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Part C Period 1 (4 Days)
COMPLETED
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6
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Part C Period 1 (4 Days)
NOT COMPLETED
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Part C Washout 1 (7 Days)
STARTED
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6
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6
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Part C Washout 1 (7 Days)
COMPLETED
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0
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5
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5
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Part C Washout 1 (7 Days)
NOT COMPLETED
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0
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1
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Part C Period2(4days)+Follow-up(14days)
STARTED
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0
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5
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5
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Part C Period2(4days)+Follow-up(14days)
COMPLETED
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0
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0
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0
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0
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5
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5
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Part C Period2(4days)+Follow-up(14days)
NOT COMPLETED
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
GSK3439171A 5 mg/Placebo/GSK3439171A 30 mg
Participants were administered a single oral dose of 5 milligrams (mg) GSK3439171A on Day 1 of treatment period 1, followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Placebo/ GSK3439171A 10 mg/GSK3439171A 30 mg
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A in treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 5 mg/GSK3439171A 10 mg/Placebo
Participants were administered a single oral dose of 5 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg/GSK3439171A 120 mg/Placebo
Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants then administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Placebo/ GSK3439171A 120 mg/GSK3439171A 180 mg
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg/Placebo/GSK3439171A 180 mg
Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Placebo
Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 5 mg
Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 11 mg
Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 40 mg
Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg Fasted/GSK3439171A 60 mg Fed
Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg Fed/GSK3439171A 60 mg Fasted
Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Washout 2 (7 Days)
Adverse Event
|
1
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part B (Maximum of 34 Days)
Adverse Event
|
0
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0
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0
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0
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0
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0
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0
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0
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2
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0
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0
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0
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Part C Washout 1 (7 Days)
Adverse Event
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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1
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Baseline Characteristics
First Time in Human (FTIH) Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of GSK3439171A in Healthy Subjects and to Assess Food Effect
Baseline characteristics by cohort
| Measure |
GSK3439171A 5 mg/Placebo/GSK3439171A 30 mg
n=3 Participants
Participants were administered a single oral dose of 5 milligrams (mg) GSK3439171A on Day 1 of treatment period 1, followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Placebo/ GSK3439171A 10 mg/GSK3439171A 30 mg
n=3 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 30 mg GSK3439171A in treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 5 mg/GSK3439171A 10 mg/Placebo
n=3 Participants
Participants were administered a single oral dose of 5 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 10 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg/GSK3439171A 120 mg/Placebo
n=3 Participants
Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants then administered a single oral dose of placebo on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Placebo/ GSK3439171A 120 mg/GSK3439171A 180 mg
n=3 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1 followed by a single oral dose of 120 mg GSK3439171A on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg/Placebo/GSK3439171A 180 mg
n=3 Participants
Participants were administered a single oral dose of 60 mg GSK3439171A on Day 1 of treatment period 1 followed by a single oral dose of placebo on Day 1 of treatment period 2. Participants were further administered a single oral dose of 180 mg GSK3439171A on Day 1 of treatment period 3. There was a washout of 7 days between dosing in each treatment period. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Placebo
n=9 Participants
Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 5 mg
n=9 Participants
Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 11 mg
n=9 Participants
Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 40 mg
n=9 Participants
Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg Fasted/GSK3439171A 60 mg Fed
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
GSK3439171A 60 mg Fed/GSK3439171A 60 mg Fasted
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of treatment period 1 followed by a washout of 7 days. In treatment period 2, participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.0 Years
STANDARD_DEVIATION 4.58 • n=5 Participants
|
43.0 Years
STANDARD_DEVIATION 2.65 • n=7 Participants
|
37.3 Years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
44.3 Years
STANDARD_DEVIATION 12.50 • n=4 Participants
|
49.0 Years
STANDARD_DEVIATION 9.17 • n=21 Participants
|
42.0 Years
STANDARD_DEVIATION 7.55 • n=10 Participants
|
46.7 Years
STANDARD_DEVIATION 8.83 • n=115 Participants
|
37.6 Years
STANDARD_DEVIATION 9.26 • n=6 Participants
|
45.0 Years
STANDARD_DEVIATION 8.80 • n=6 Participants
|
41.6 Years
STANDARD_DEVIATION 10.31 • n=64 Participants
|
38.3 Years
STANDARD_DEVIATION 12.89 • n=17 Participants
|
47.8 Years
STANDARD_DEVIATION 6.21 • n=21 Participants
|
42.7 Years
STANDARD_DEVIATION 9.37 • n=22 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
9 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
66 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian Heritage
|
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
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
4 Participants
n=21 Participants
|
31 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
32 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
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=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Up to Day 40Population: Safety Population comprised of all participants who took at least one dose of study intervention. Participants were analyzed according to the intervention they actually received.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Outcome measures
| Measure |
Part A: Placebo
n=17 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A
Any AE
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 34Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With AEs and SAEs-Part B
Any AE
|
4 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With AEs and SAEs-Part B
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 29Population: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With AEs and SAEs-Part C
Any AE
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With AEs and SAEs-Part C
Any SAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 40Population: Safety Population
Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 grams per liter \[g/L\]); alanine aminotransferase (ALT) (high: \>=2xupper limit of normal \[ULN\]); aspartate aminotransferase (AST) (high: \>=2xULN); alkaline phosphatase (ALP) (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 millimoles (mmol)/L and high: \>2.75 mmol/L); creatinine (high: change from Baseline \>44.2 micromoles/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L); sodium (low: \<130 mmol/L and high: \>150 mmol/L) and creatine kinase (high: \>500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported.
Outcome measures
| Measure |
Part A: Placebo
n=17 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 34Population: Safety Population
Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 g/L); ALT (high: \>=2xULN); AST (high: \>=2xULN); ALP (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 mmol/L and high: \>2.75 mmol/L); creatinine (high: change from Baseline \>44.2 micromoles/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L); sodium (low: \<130 mmol/L and high: \>150 mmol/L) and creatine kinase (high: \>500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part B
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 29Population: Safety Population
Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: \<30 g/L); ALT (high: \>=2xULN); AST (high: \>=2xULN); ALP (high: \>=2xULN); total bilirubin (high: \>=1.5xULN); calcium (low: \<2 mmol/L and high: \>2.75 mmol/L); creatinine (high: change from Baseline \>44.2 micromoles/L); glucose (low: \<3 mmol/L and high: \>9 mmol/L); magnesium (low: 0.5 mmol/L and high: 1.23 mmol/L); phosphorus (low: 0.8 mmol/L and high: 1.6 mmol/L); potassium (low: \<3 mmol/L and high: \>5.5 mmol/L); sodium (low: \<130 mmol/L and high: \>150 mmol/L) and creatine kinase (high: \>500 units per liter). The number of participants with any clinical chemistry abnormality of potential clinical importance is reported.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance-Part C
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 40Population: Safety Population
Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 g/L), lymphocytes (low: \<0.8x10\^9 cells per liter \[cells/L\]); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported.
Outcome measures
| Measure |
Part A: Placebo
n=17 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part A
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 34Population: Safety Population
Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 g/L), lymphocytes (low: \<0.8x10\^9 cells/L); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part B
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 29Population: Safety Population
Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: \>0.54 proportion of red blood cells in blood); hemoglobin (high: \>180 g/L), lymphocytes (low: \<0.8x10\^9 cells/L); neutrophil count (low: \<1.5x10\^9 cells/L); platelet count (low: \<100x10\^9 cells/L and high: \>550x10\^9 cells/L); white blood cells count (low: \<3x10\^9 cells/L and high: \>20x10\^9 cells/L). The number of participants with any hematology abnormality of potential clinical importance is reported.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Abnormalities of Potential Clinical Importance-Part C
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 hours, 24 hours, 48 hours and 72 hours in Periods 1, 2 and 3Population: Safety Population. All participants in Part A (17, 6, 6, 5, 6, 6, 6) were included in the analysis; however, only participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Urine samples were taken for the assessment of following urine parameters: glucose, ketones, occult blood (OB) and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample.
Outcome measures
| Measure |
Part A: Placebo
n=17 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 8 hours;Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 8 hours;1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 8 hours;2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 24 hours;Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 24 hours;1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 48 hours;Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 48 hours;1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 48 hours;2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 72 hours;Trace;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 72 hours;1+;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 1; 72 hours;2+;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 8 hours;Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Glucose; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 8 hours; Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 72 hours; Trace;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 72 hours; 1+;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 1; 72 hours; 2+;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
00 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Ketones; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 8 hours; Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0
|
1 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 72 hours; Trace;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 72 hours; 1+;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 1; 72 hours; 2+;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 2; 72 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 8 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 8 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 8 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 24 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
2 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
OB; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 8 hours;Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 8 hours; 1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 8 hours; 2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 24 hours; Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 24 hours; 1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 24 hours;2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 48 hours; Trace;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 48 hours; 1+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 48 hours; 2+;n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 72 hours; Trace;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 72 hours; 1+;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 1; 72 hours; 2+;n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 8 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 8 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 8 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 24 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 24 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 24 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 48 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 48 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 48 hours; 2+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 72 hours; Trace;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 2; 72 hours; 1+;n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 24 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 24 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 48 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 48 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 48 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 72 hours; Trace;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 72 hours; 1+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part A
Protein; Period 3; 72 hours; 2+;n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: 8 hours, 24 hours, 48 hours and 72 hours in Periods 1, 2 and 3Population: Safety Population. All participants in Part A (17, 6, 6, 5, 6, 6, 6) were included in the analysis; however, only participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Urine samples were taken for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9.
Outcome measures
| Measure |
Part A: Placebo
n=17 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 48 hours; pH=7; n=6,0,6,0,0,6,0
|
1 Participants
|
—
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 48 hours; pH=8; n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 48 hours; pH=9; n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 72 hours; pH=5; n=6,0,6,0,0,6,0
|
1 Participants
|
—
|
1 Participants
|
—
|
—
|
4 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 72 hours; pH=6; n=6,0,6,0,0,6,0
|
5 Participants
|
—
|
3 Participants
|
—
|
—
|
2 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 72 hours; pH=7; n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 72 hours; pH=8; n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 72 hours; pH=9; n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 8 hours; pH=5; n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 8 hours; pH=6; n=5,0,0,5,0,0,6
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 8 hours; pH=7; n=5,0,0,5,0,0,6
|
2 Participants
|
—
|
—
|
3 Participants
|
—
|
—
|
1 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 8 hours; pH=8; n=5,0,0,5,0,0,6
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 8 hours; pH=9; n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 24 hours; pH=5; n=5,0,0,5,0,0,6
|
2 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 24 hours; pH=6; n=5,0,0,5,0,0,6
|
3 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 24 hours; pH=7; n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 24 hours; pH=8; n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 24 hours; pH=9; n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 48 hours; pH=5; n=5,0,0,5,0,0,6
|
2 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
2 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 48 hours; pH=6; n=5,0,0,5,0,0,6
|
2 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
4 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 48 hours; pH=7; n=5,0,0,5,0,0,6
|
1 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 48 hours; pH=8; n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 48 hours; pH=9; n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 72 hours; pH=5; n=5,0,0,5,0,0,6
|
1 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 72 hours; pH=6; n=5,0,0,5,0,0,6
|
4 Participants
|
—
|
—
|
3 Participants
|
—
|
—
|
3 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 72 hours; pH=7; n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 72 hours; pH=8; n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 3; 72 hours; pH=9; n=5,0,0,5,0,0,6
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 8 hours; pH=5; n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 8 hours; pH=6; n=6,6,0,0,6,0,0
|
1 Participants
|
1 Participants
|
—
|
—
|
3 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 8 hours; pH=7; n=6,6,0,0,6,0,0
|
3 Participants
|
5 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 8 hours; pH=8; n=6,6,0,0,6,0,0
|
2 Participants
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 8 hours; pH=9; n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 24 hours; pH=5; n=6,6,0,0,6,0,0
|
4 Participants
|
3 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 24 hours; pH=6; n=6,6,0,0,6,0,0
|
2 Participants
|
3 Participants
|
—
|
—
|
3 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 24 hours; pH=7; n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 24 hours; pH=8; n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 24 hours; pH=9; n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 48 hours; pH=5; n=6,6,0,0,6,0,0
|
1 Participants
|
1 Participants
|
—
|
—
|
4 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 48 hours; pH=6; n=6,6,0,0,6,0,0
|
4 Participants
|
3 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 48 hours; pH=7; n=6,6,0,0,6,0,0
|
1 Participants
|
2 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 48 hours; pH=8; n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 48 hours; pH=9; n=6,6,0,0,6,0,0
|
0 Participants
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 72 hours; pH=5; n=3,0,0,0,6,0,0
|
2 Participants
|
—
|
—
|
—
|
2 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 72 hours; pH=6; n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
4 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 72 hours; pH=7; n=3,0,0,0,6,0,0
|
1 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 72 hours; pH=8; n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 1; 72 hours; pH=9; n=3,0,0,0,6,0,0
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 8 hours; pH=5; n=6,0,6,0,0,6,0
|
1 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 8 hours; pH=6; n=6,0,6,0,0,6,0
|
2 Participants
|
—
|
0 Participants
|
—
|
—
|
2 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 8 hours; pH=7; n=6,0,6,0,0,6,0
|
3 Participants
|
—
|
6 Participants
|
—
|
—
|
2 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 8 hours; pH=8; n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
2 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 8 hours; pH=9; n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 24 hours; pH=5; n=6,0,6,0,0,6,0
|
3 Participants
|
—
|
2 Participants
|
—
|
—
|
3 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 24 hours; pH=6; n=6,0,6,0,0,6,0
|
3 Participants
|
—
|
3 Participants
|
—
|
—
|
3 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 24 hours; pH=7; n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 24 hours; pH=8; n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 24 hours; pH=9; n=6,0,6,0,0,6,0
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
-Period 2; 48 hours; pH=5; n=6,0,6,0,0,6,0
|
3 Participants
|
—
|
2 Participants
|
—
|
—
|
4 Participants
|
—
|
|
Number of Participants With Urinalysis Dipstick Results for Potential of Hydrogen (pH)-Part A
Period 2; 48 hours; pH=6; n=6,0,6,0,0,6,0
|
2 Participants
|
—
|
1 Participants
|
—
|
—
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 2 (24 hours); Day 3 (48 hours); Days 4, 13 and 20 (72 hours); pre-dose on Days 7, 10, 11 and 17Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were taken for the assessment of following urine parameters: glucose, ketones, OB and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day2, 24 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day2, 24 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day2, 24 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day3, 48 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day3, 48 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day3, 48 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day4, 72 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day4, 72 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day4, 72 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day7, pre-dose; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day7, pre-dose; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day7, pre-dose; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day10, pre-dose; Trace; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day10, pre-dose; 1+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day10, pre-dose; 2+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day 11, pre-dose; Trace; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day 11, pre-dose; 1+; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day11, pre-dose; 2+; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day13, 72 hours; Trace; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day13, 72 hours; 1+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day13, 72 hours; 2+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day17, pre-dose; Trace; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day17, pre-dose; 1+; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day17, pre-dose; 2+; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day20, 72 hours; Trace; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day20, 72 hours; 1+; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Glucose; Day20, 72 hours; 2+; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day2, 24 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day2, 24 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day2, 24 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day3, 48 hours; Trace; ; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day3, 48 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day3, 48 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day4, 72 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day4, 72 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day4, 72 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day7, pre-dose; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day7, pre-dose; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day7, pre-dose; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day10, pre-dose; Trace; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day10, pre-dose; 1+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day10, pre-dose; 2+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day 11, pre-dose; Trace; n=6,9,9,0
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day11, pre-dose; 1+; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day11, pre-dose; 2+; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day13, 72 hours; Trace; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day13, 72 hours; 1+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day13, 72 hours; 2+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day17, pre-dose; Trace; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day17, pre-dose; 1+; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day17, pre-dose; 2+; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day20, 72 hours; Trace; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day20, 72 hours; 1+; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Ketones; Day20, 72 hours; 2+; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day2, 24 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day2, 24 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day2, 24 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day3, 48 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day3, 48 hours; 1+; n=9,9,9,9
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day3, 48 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day4, 72 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day4, 72 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day4, 72 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day7, pre-dose; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day7, pre-dose; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day7, pre-dose; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day10, pre-dose; Trace; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day10, pre-dose; 1+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day10, pre-dose; 2+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day 11, pre-dose; Trace; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day11, pre-dose; 1+; n=6,9,9,0
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day11, pre-dose; 2+; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day13, 72 hours; Trace; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day13, 72 hours; 1+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day13, 72 hours; 2+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day17, pre-dose; Trace; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day17, pre-dose; 1+; n=6,9,8,0
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day17, pre-dose; 2+; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day20, 72 hours; Trace; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day20, 72 hours; 1+; n=6,9,7,0
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
OB; Day20, 72 hours; 2+; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day2, 24 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day2, 24 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day2, 24 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day3, 48 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day3, 48 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day3, 48 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day4, 72 hours; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day4, 72 hours; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day4, 72 hours; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day7, pre-dose; Trace; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day7, pre-dose; 1+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day7, pre-dose; 2+; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day10, pre-dose; Trace; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day10, pre-dose; 1+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day10, pre-dose; 2+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day 11, pre-dose; Trace; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day11, pre-dose; 1+; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day11, pre-dose; 2+; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day13, 72 hours; Trace; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day13, 72 hours; 1+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day13, 72 hours; 2+; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day17, pre-dose; Trace; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day17, pre-dose; 1+; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day17, pre-dose; 2+; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day20, 72 hours; Trace; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day20, 72 hours; 1+; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part B
Protein; Day20, 72 hours; 2+; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 (24 hours); Day 3 (48 hours); Days 4, 13 and 20 (72 hours); pre-dose on Days 7, 10, 11 and 17Population: Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Urine samples were taken for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day4, 72 hours; pH=7; n=9,9,9,9
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day4, 72 hours; pH=9; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day 11, pre-dose; pH=9; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day 11, pre-dose; pH=7; n=6,9,9,0
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day2, 24 hours; pH=5; n=9,9,9,9
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day2, 24 hours; pH=6; n=9,9,9,9
|
4 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day2, 24 hours; pH=7; n=9,9,9,9
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day2, 24 hours; pH=8; n=9,9,9,9
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day2, 24 hours; pH=9; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day3, 48 hours; pH=5; n=9,9,9,9
|
1 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day3, 48 hours; pH=6; n=9,9,9,9
|
6 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day3, 48 hours; pH=7; n=9,9,9,9
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day3, 48 hours; pH=8; n=9,9,9,9
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day3, 48 hours; pH=9; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day 11, pre-dose; pH=8; n=6,9,9,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day4, 72 hours; pH=5; n=9,9,9,9
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day4, 72 hours; pH=6; n=9,9,9,9
|
5 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day4, 72 hours; pH=8; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day7, pre-dose; pH=5; n=9,9,9,9
|
1 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day7, pre-dose; pH=6; n=9,9,9,9
|
3 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day7, pre-dose; pH=7; n=9,9,9,9
|
5 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day7, pre-dose; pH=8; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day7, pre-dose; pH=9; n=9,9,9,9
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day10, pre-dose; pH=5; n=3,0,0,9
|
1 Participants
|
—
|
—
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day10, pre-dose; pH=6; n=3,0,0,9
|
2 Participants
|
—
|
—
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day10, pre-dose; pH=7; n=3,0,0,9
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day10, pre-dose; pH=8; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day10, pre-dose; pH=9; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day 11, pre-dose; pH=5; n=6,9,9,0
|
0 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day 11, pre-dose; pH=6; n=6,9,9,0
|
3 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day13, 72 hours; pH=5; n=3,0,0,9
|
0 Participants
|
—
|
—
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day13, 72 hours; pH=6; n=3,0,0,9
|
2 Participants
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day13, 72 hours; pH=7; n=3,0,0,9
|
1 Participants
|
—
|
—
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day13, 72 hours; pH=8; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day13, 72 hours; pH=9; n=3,0,0,9
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day17, pre-dose; pH=5; n=6,9,8,0
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day17, pre-dose; pH=6; n=6,9,8,0
|
1 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day17, pre-dose; pH=7; n=6,9,8,0
|
4 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day17, pre-dose; pH=8; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day17, pre-dose; pH=9; n=6,9,8,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day20, 72 hours; pH=5; n=6,9,7,0
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day20, 72 hours; pH=6; n=6,9,7,0
|
2 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day20, 72 hours; pH=7; n=6,9,7,0
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day20, 72 hours; pH=8; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part B
Day20, 72 hours; pH=9; n=6,9,7,0
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 hours, 24 hours, 48 hours and 72 hours in Period 1 and Period 2Population: Safety Population. All participants in Part C (11, 11) were included in the analysis; however, only participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Urine samples were taken for the assessment of following urine parameters: glucose, ketones, OB and protein by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results can be read as Trace, 1+, 2+ indicating proportional concentrations in the urine sample.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 72 hours; 1+; n=6,6
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 72 hours; 2+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 24 hours; 1+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 8 hours; 2+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 8 hours; 1+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 24 hours; Trace; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 24 hours; 1+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 24 hours; 2+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 48 hours; Trace; n=6,6
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 48 hours; 1+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 48 hours; 2+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 72 hours; Trace; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 8 hours; Trace; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 8 hours; 1+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 8 hours; 2+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 24 hours; Trace; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 24 hours; 2+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 48 hours; Trace; n=5,5
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 48 hours; 1+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 48 hours; 2+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 72 hours; Trace; n=5,5
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 72 hours; 1+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 2, 72 hours; 2+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 8 hours; Trace; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 8 hours; 1+; n=6, 6
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 8 hours; 2+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 24 hours; Trace; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 24 hours; 1+; n=6, 6
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 24 hours; 2+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 48 hours; Trace; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 48 hours; 1+; n=6, 6
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 48 hours; 2+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 72 hours; Trace; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 72 hours; 1+; n=6, 6
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 1, 72 hours; 2+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 8 hours; Trace; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 8 hours; 1+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 8 hours; 2+; n=5,5
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 24 hours; Trace; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 24 hours; 1+; n=5,5
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 24 hours; 2+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 48 hours; Trace; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 48 hours; 1+; n=5,5
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 48 hours; 2+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 72 hours; Trace; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 72 hours; 1+; n=5,5
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
OB; Period 2, 72 hours; 2+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 8 hours; Trace; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 8 hours; 1+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 8 hours; 2+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 24 hours; Trace; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 24 hours; 1+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 24 hours; 2+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 48 hours; Trace; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 48 hours; 1+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 48 hours; 2+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 72 hours; Trace; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 72 hours; 1+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 1, 72 hours; 2+; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 8 hours; Trace; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 8 hours; 1+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 8 hours; 2+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 24 hours; Trace; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 24 hours; 1+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 24 hours; 2+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 48 hours; Trace;n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 48 hours; 1+;n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 48 hours; 2+;n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 72 hours; Trace; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 72 hours; 1+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Protein; Period 2, 72 hours; 2+; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 8 hours; Trace; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 8 hours; 1+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 8 hours; 2+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 24 hours; Trace; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 24 hours; 1+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 24 hours; 2+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 48 hours; Trace; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 48 hours; 1+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 48 hours; 2+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 72 hours; Trace; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 72 hours; 1+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 1, 72 hours; 2+; n=6, 6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 8 hours; Trace; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 8 hours; 1+; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 8 hours; 2+;n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 72 hours; 1+; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 24 hours; Trace; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 24 hours; 1+; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 24 hours; 2+; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 48 hours; Trace; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 48 hours; 1+; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 48 hours; 2+; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 72 hours; Trace; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Glucose; Period 2, 72 hours; 2+; n=5, 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Urinalysis Dipstick Results-Part C
Ketone; Period 1, 8 hours; Trace; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 8 hours, 24 hours, 48 hours and 72 hours in Period 1 and Period 2Population: Safety Population. All participants in Part C (11, 11) were included in the analysis; however, only participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Urine samples were taken for the assessment of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 to 6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 7, 8 or 9.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 8 hours; pH=5; n=6,6
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 8 hours; pH=6; n=6,6
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 8 hours; pH=7; n=6,6
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 8 hours; pH=8; n=6,6
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 8 hours; pH=9; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 24 hours; pH=5; n=6,6
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 24 hours; pH=6; n=6,6
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 24 hours; pH=7; n=6,6
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 24 hours; pH=8; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 24 hours; pH=9; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 48 hours; pH=5; n=6,6
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 48 hours; pH=6; n=6,6
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 48 hours; pH=7; n=6,6
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 48 hours; pH=8; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 48 hours; pH=9; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 72 hours; pH=5; n=6,6
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 72 hours; pH=6; n=6,6
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 72 hours; pH=7; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 72 hours; pH=8; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 1, 72 hours; pH=9; n=6,6
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 8 hours; pH=5; n=5,5
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 8 hours; pH=6; n=5,5
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 8 hours; pH=7; n=5,5
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 8 hours; pH=8; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 8 hours; pH=9; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 24 hours; pH=5; n=5,5
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 24 hours; pH=6; n=5,5
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 24 hours; pH=7; n=5,5
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 24 hours; pH=8; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 24 hours; pH=9; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 48 hours; pH=5; n=5,5
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 48 hours; pH=6; n=5,5
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 48 hours; pH=7; n=5,5
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 48 hours; pH=8; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 48 hours; pH=9; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 72 hours; pH=5; n=5,5
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 72 hours; pH=6; n=5,5
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 72 hours; pH=7; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 72 hours; pH=8; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Urinalysis Dipstick Results (pH)-Part C
Period 2, 72 hours; pH=9; n=5,5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 40Population: Safety Population
Vital signs were measured in a supine position after five minutes of rest and included temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: \<85 millimeters of mercury \[mmHg\] and high: \>160 mmHg), DBP (low: \<45 mmHg and high: \>100 mmHg) and heart rate (low: \<40 beats per minute \[bpm\] and high: \>110 bpm). Number of participants with any vital signs of potential clinical importance is reported.
Outcome measures
| Measure |
Part A: Placebo
n=17 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs of Potential Clinical Importance-Part A
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 34Population: Safety Population
Vital signs were measured in a supine position after five minutes of rest and included temperature, SBP, DBP, heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: \<85 mmHg and high: \>160 mmHg), DBP (low: \<45 mmHg and high: \>100 mmHg) and heart rate (low: \<40 bpm and high: \>110 bpm). Number of participants with any vital signs of potential clinical importance is reported.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs of Potential Clinical Importance-Part B
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 29Population: Safety Population
Vital signs were measured in a supine position after five minutes of rest and included temperature, SBP, DBP, heart rate and respiratory rate. The clinical concern range for the parameters included: SBP (low: \<85 mmHg and high: \>160 mmHg), DBP (low: \<45 mmHg and high: \>100 mmHg) and heart rate (low: \<40 bpm and high: \>110 bpm). Number of participants with any vital signs of potential clinical importance is reported.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs of Potential Clinical Importance-Part C
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 40Population: Safety Population
Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part A: Placebo
n=17 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A
NCS
|
16 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A
CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 34Population: Safety Population
Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and QTc intervals. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal ECG Findings-Part B
NCS
|
9 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Abnormal ECG Findings-Part B
CS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 29Population: Safety Population
Twelve-lead ECGs were recorded with the participants in a supine position using an ECG machine that automatically calculated heart rate and measured PR, QRS, QT and QTc intervals. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case post-Baseline is presented. Baseline value is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal ECG Findings-Part C
NCS
|
10 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal ECG Findings-Part C
CS
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dosePopulation: Pharmacokinetic Population comprised of participants in the Safety population for whom a Pharmacokinetic sample was taken and analyzed for GSK3439171A and result reported
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Area Under Tha Plasma Drug Concentration Versus Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0 to t]) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only)
|
1180.6 Hours*nanograms per milliliter
Geometric Coefficient of Variation 48.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to t) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg)
|
2268.6 Hours*nanograms per milliliter
Geometric Coefficient of Variation 34.4
|
9289.4 Hours*nanograms per milliliter
Geometric Coefficient of Variation 22.3
|
17052.3 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.9
|
35822.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 25.3
|
46086.3 Hours*nanograms per milliliter
Geometric Coefficient of Variation 14.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
1474.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 24.6
|
2299.2 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=7 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
2072.8 Hours*nanograms per milliliter
Geometric Coefficient of Variation 30.7
|
3628.1 Hours*nanograms per milliliter
Geometric Coefficient of Variation 39.6
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to t) of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only)
|
10031.8 Hours*nanograms per milliliter
Geometric Coefficient of Variation 24.5
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to t) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only)
|
14896.5 Hours*nanograms per milliliter
Geometric Coefficient of Variation 26.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0 to Inf]) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only)
|
1247.2 Hours*nanograms per milliliter
Geometric Coefficient of Variation 51.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to Inf) of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg)
|
2305.3 Hours*nanograms per milliliter
Geometric Coefficient of Variation 34.5
|
9441.8 Hours*nanograms per milliliter
Geometric Coefficient of Variation 22.2
|
17257.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 28.7
|
36478.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 26.1
|
46844.6 Hours*nanograms per milliliter
Geometric Coefficient of Variation 15.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
1514.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 25.1
|
2345.6 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=7 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
2129.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 31.8
|
3687.1 Hours*nanograms per milliliter
Geometric Coefficient of Variation 40.2
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to Inf) of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only)
|
10182.6 Hours*nanograms per milliliter
Geometric Coefficient of Variation 24.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to Inf) of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only)
|
15098.7 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.3
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only)
|
111.01 Nanograms per milliliter
Geometric Coefficient of Variation 10.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Cmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg)
|
214.03 Nanograms per milliliter
Geometric Coefficient of Variation 28.1
|
635.37 Nanograms per milliliter
Geometric Coefficient of Variation 26.8
|
1272.26 Nanograms per milliliter
Geometric Coefficient of Variation 19.4
|
2132.49 Nanograms per milliliter
Geometric Coefficient of Variation 19.1
|
2938.01 Nanograms per milliliter
Geometric Coefficient of Variation 21.2
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
117.40 Nanograms per milliliter
Geometric Coefficient of Variation 25.1
|
192.62 Nanograms per milliliter
Geometric Coefficient of Variation 20.8
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=7 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
138.08 Nanograms per milliliter
Geometric Coefficient of Variation 19.3
|
243.98 Nanograms per milliliter
Geometric Coefficient of Variation 28.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Cmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only)
|
682.62 Nanograms per milliliter
Geometric Coefficient of Variation 24.8
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Cmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only)
|
1016.29 Nanograms per milliliter
Geometric Coefficient of Variation 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only)
|
1.0000 Hours
Interval 0.5 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Tmax of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg)
|
0.9830 Hours
Interval 0.5 to 4.0
|
1.5000 Hours
Interval 0.5 to 3.0
|
1.7415 Hours
Interval 0.5 to 3.0
|
4.0000 Hours
Interval 2.017 to 4.0
|
2.9915 Hours
Interval 1.65 to 4.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
1.5000 Hours
Interval 0.483 to 4.0
|
2.0000 Hours
Interval 1.5 to 3.983
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=7 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
3.0000 Hours
Interval 1.0 to 4.0
|
2.0000 Hours
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Tmax of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only)
|
4.0000 Hours
Interval 1.483 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Tmax of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only)
|
3.0000 Hours
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (T1/2) of GSK3439171A Following Single Dose-Part A (GSK3439171A 5 mg Only)
|
9.847 Hours
Geometric Coefficient of Variation 46.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=5 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 Participants
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
T1/2 of GSK3439171A Following Single Dose-Part A (GSK3439171A 10 mg, 30 mg, 60 mg, 120 mg and 180 mg)
|
11.233 Hours
Geometric Coefficient of Variation 44.6
|
11.956 Hours
Geometric Coefficient of Variation 7.5
|
11.183 Hours
Geometric Coefficient of Variation 17.8
|
11.761 Hours
Geometric Coefficient of Variation 19.3
|
11.076 Hours
Geometric Coefficient of Variation 22.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
15.348 Hours
Geometric Coefficient of Variation 26.6
|
14.275 Hours
Geometric Coefficient of Variation 32.4
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=7 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
13.253 Hours
Geometric Coefficient of Variation 23.8
|
11.584 Hours
Geometric Coefficient of Variation 11.3
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
T1/2 of GSK3439171A Following Single Dose-Part B (GSK3439171A 40 mg Only)
|
11.908 Hours
Geometric Coefficient of Variation 18.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
T1/2 of GSK3439171A Following Repeat Dose-Part B (GSK3439171A 40 mg Only)
|
10.948 Hours
Geometric Coefficient of Variation 18.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to t) of GSK3439171A (Food Effect)-Part C
|
16263.2 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.0
|
14770.1 Hours*nanograms per milliliter
Geometric Coefficient of Variation 29.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
AUC(0 to Inf) of GSK3439171A (Food Effect)-Part C
|
16458.9 Hours*nanograms per milliliter
Geometric Coefficient of Variation 27.4
|
14995.0 Hours*nanograms per milliliter
Geometric Coefficient of Variation 29.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Cmax for GSK3439171A (Food Effect)-Part C
|
1155.60 Nanograms per milliliter
Geometric Coefficient of Variation 16.3
|
1025.45 Nanograms per milliliter
Geometric Coefficient of Variation 21.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Tmax for GSK3439171A-Part C
|
3.0000 Hours
Interval 1.0 to 4.033
|
4.0000 Hours
Interval 1.5 to 4.017
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=11 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=11 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
T1/2 for GSK3439171A-Part C
|
10.820 Hours
Geometric Coefficient of Variation 13.7
|
11.679 Hours
Geometric Coefficient of Variation 19.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.
Outcome measures
| Measure |
Part A: Placebo
n=18 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Dose Proportionality of GSK3439171A Using AUC(0 to t) Following a Single Dose-Part A
|
1.068 Slope of log dose
Interval 1.001 to 1.136
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90 % confidence interval for the slope are presented.
Outcome measures
| Measure |
Part A: Placebo
n=18 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Dose Proportionality of GSK3439171A Using AUC(0 to Inf) Following a Single Dose-Part A
|
1.057 Slope of log dose
Interval 0.988 to 1.125
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dosePopulation: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.
Outcome measures
| Measure |
Part A: Placebo
n=18 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Dose Proportionality of GSK3439171A Using Cmax Following a Single Dose-Part A
|
0.944 Slope of log dose
Interval 0.892 to 0.997
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 10 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.
Outcome measures
| Measure |
Part A: Placebo
n=25 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Dose Proportionality of GSK3439171A Using AUC(0 to Tau) Following Repeat Dose-Part B
|
0.966 Slope of log dose
Interval 0.863 to 1.069
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 10 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Dose proportionality was assessed using Power model with fixed effects of logarithm of treatment and participant as random effect. Slope and 90% confidence interval for the slope are presented.
Outcome measures
| Measure |
Part A: Placebo
n=25 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Dose Proportionality of GSK3439171A Using Cmax Following Repeat Dose-Part B
|
0.972 Slope of log dose
Interval 0.877 to 1.066
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. AUC(Ro) was calculated as Day17 AUC(0 to tau) divided by Day 1 AUC (0 to tau). Analysis was performed using Mixed effect model with AUC (0 to tau) as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=7 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 5 mg and 11 mg)
|
1.39 Ratio
Interval 1.29 to 1.49
|
1.52 Ratio
Interval 1.4 to 1.64
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. AUC(Ro) was calculated as Day10 AUC(0 to tau) divided by Day 1 AUC (0 to tau). Analysis was performed using Mixed effect model with AUC (0 to tau) as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio for AUC (AUC[Ro])-Part B (GSK3439171A 40 mg Only)
|
1.49 Ratio
Interval 1.39 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. RCmax was calculated as Day17 Cmax divided by Day 1 Cmax. Analysis was performed using Mixed effect model with Cmax as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=7 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 5 mg and 11 mg)
|
1.18 Ratio
Interval 1.05 to 1.31
|
1.28 Ratio
Interval 1.13 to 1.45
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. RCmax was calculated as Day10 Cmax divided by Day 1 Cmax. Analysis was performed using Mixed effect model with Cmax as the response variable. Treatment, visit and treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio for Cmax (RCmax)-Part B (GSK3439171A 40 mg Only)
|
1.49 Ratio
Interval 1.33 to 1.66
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 17 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Rss was calculated as Day 17 AUC(0-tau) divided by Day 1 AUC(0-inf). Analysis was performed using Mixed Effect Model, with AUC(0-tau) and AUC(0-inf) as the response variables. Treatment, visit, parameter and parameter-by-treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=7 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 5 mg and 11 mg)
|
1.07 Ratio
Interval 1.01 to 1.14
|
1.21 Ratio
Interval 1.13 to 1.29
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 10 (pre-dose, 0.083, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 60 and 72 hours post-dose)Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Rss was calculated as Day 10 AUC(0-tau) divided by Day 1 AUC(0-inf). Analysis was performed using Mixed Effect Model, with AUC(0-tau) and AUC(0-inf) as the response variables. Treatment, visit, parameter and parameter-by-treatment-by-visit interaction are added as fixed effects and participant as random effect. Ratio and 90% confidence interval of the ratio is presented.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Steady State Accumulation Ratio (Rss)-Part B (GSK3439171A 40 mg Only)
|
1.16 Ratio
Interval 1.1 to 1.23
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose on Days 6, 7, 9, 10, 11, 15, 16 and 17Population: Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg)
pre-dose Day 6; n=9, 9
|
27.3206 Nanograms per milliliter
Geometric Coefficient of Variation 42.3
|
35.6842 Nanograms per milliliter
Geometric Coefficient of Variation 55.9
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg)
pre-dose Day 7; n=9, 9
|
29.5449 Nanograms per milliliter
Geometric Coefficient of Variation 44.5
|
41.6334 Nanograms per milliliter
Geometric Coefficient of Variation 61.5
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg)
pre-dose Day 9; n=9, 9
|
28.5910 Nanograms per milliliter
Geometric Coefficient of Variation 46.0
|
38.2703 Nanograms per milliliter
Geometric Coefficient of Variation 65.3
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg)
pre-dose Day 10; n=9, 9
|
29.2380 Nanograms per milliliter
Geometric Coefficient of Variation 44.1
|
35.4203 Nanograms per milliliter
Geometric Coefficient of Variation 76.8
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg)
pre-dose Day 11; n=9, 9
|
28.8443 Nanograms per milliliter
Geometric Coefficient of Variation 42.8
|
30.4420 Nanograms per milliliter
Geometric Coefficient of Variation 105.7
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg)
pre-dose Day 15; n=9, 9
|
26.2039 Nanograms per milliliter
Geometric Coefficient of Variation 58.0
|
30.8384 Nanograms per milliliter
Geometric Coefficient of Variation 247.3
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg)
pre-dose Day 16; n=9, 9
|
27.4434 Nanograms per milliliter
Geometric Coefficient of Variation 51.3
|
24.9684 Nanograms per milliliter
Geometric Coefficient of Variation 362.7
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9, 10, 11, 15, 16 and 17-Part B (GSK3439171A 5 mg and 11 mg)
pre-dose Day 17; n=9, 7
|
28.5046 Nanograms per milliliter
Geometric Coefficient of Variation 47.3
|
48.0658 Nanograms per milliliter
Geometric Coefficient of Variation 52.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose on Days 6, 7, 9 and 10Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only)
pre-dose Day 6
|
184.1428 Nanograms per milliliter
Geometric Coefficient of Variation 40.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only)
pre-dose Day 7
|
209.1741 Nanograms per milliliter
Geometric Coefficient of Variation 37.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only)
pre-dose Day 9
|
211.2785 Nanograms per milliliter
Geometric Coefficient of Variation 37.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Trough Plasma Concentrations at the End of Dosing Interval for Repeat Doses on Days 6, 7, 9 and 10-Part B (GSK3439171A 40 mg Only)
pre-dose Day 10
|
215.1369 Nanograms per milliliter
Geometric Coefficient of Variation 36.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose on Days 6, 7, 9, 10, 11, 15, 16 and 17Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. The slope estimate of the day effect was obtained from Mixed Effect Model, with visit as the fixed effect and participant as random effect. The analysis was done separately for each treatment. "Variance Component" covariance structure was used. The back transformed slope and 90% confidence interval for the slope is presented.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=9 Participants
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 5 mg and 11 mg)
|
1.000 Slope
Interval 0.998 to 1.001
|
0.997 Slope
Interval 0.994 to 1.001
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose on Days 6, 7, 9 and 10Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis. The slope estimate of the day effect was obtained from Mixed Effect Model, with visit as the fixed effect and participant as random effect. The analysis was done separately for each treatment. "Variance Component" covariance structure is used. The back transformed slope and 90% confidence interval for the slope is presented.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
|---|---|---|---|---|---|---|---|
|
Steady State Assessment Using Trough Plasma Concentration at the End of Dosing Interval for Repeat Dose-Part B (GSK3439171A 40 mg Only)
|
1.003 Slope
Interval 1.002 to 1.005
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: GSK3439171A 5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: GSK3439171A 10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: GSK3439171A 30 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: GSK3439171A 60 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: GSK3439171A 120 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: GSK3439171A 180 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: GSK3439171A 5 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: GSK3439171A 11 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B: GSK3439171A 40 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part C: GSK3439171A 60 mg Fasted
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part C: GSK3439171A 60 mg Fed
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Placebo
n=17 participants at risk
Participants were administered a single oral dose of placebo on Day 1 of treatment period 1, 2 or 3.
|
Part A: GSK3439171A 5 mg
n=6 participants at risk
Participants were administered a single oral dose of GSK3439171A 5 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 10 mg
n=6 participants at risk
Participants were administered a single oral dose of GSK3439171A 10 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 30 mg
n=5 participants at risk
Participants were administered a single oral dose of GSK3439171A 30 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 60 mg
n=6 participants at risk
Participants were administered a single oral dose of GSK3439171A 60 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 120 mg
n=6 participants at risk
Participants were administered a single oral dose of GSK3439171A 120 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part A: GSK3439171A 180 mg
n=6 participants at risk
Participants were administered a single oral dose of GSK3439171A 180 mg on Day 1 of either treatment period 1, 2 or 3.
|
Part B: Placebo
n=9 participants at risk
Participants were administered placebo once daily via oral route for 13 or 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Part B: GSK3439171A 5 mg
n=9 participants at risk
Participants were administered GSK343917A 5 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Part B: GSK3439171A 11 mg
n=9 participants at risk
Participants were administered GSK343917A 11 mg once daily via oral route for 20 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Part B: GSK3439171A 40 mg
n=9 participants at risk
Participants were administered GSK343917A 40 mg once daily via oral route for 13 days. All participants were followed up for 14 days after the administration of last dose of study treatment.
|
Part C: GSK3439171A 60 mg Fasted
n=11 participants at risk
Participants were administered a single oral dose of GSK3439171A 60 mg in the fasted state on Day 1 of either treatment period 1 or 2.
|
Part C: GSK3439171A 60 mg Fed
n=11 participants at risk
Participants were administered a single oral dose of GSK3439171A 60 mg after a high fat meal on Day 1 of either treatment period 1 or 2.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
16.7%
1/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
16.7%
1/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
General disorders
Application site laceration
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
20.0%
1/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
16.7%
1/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
9.1%
1/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
16.7%
1/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Infections and infestations
Gastroenteritis
|
5.9%
1/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
16.7%
1/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
20.0%
1/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Vascular disorders
Flushing
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
16.7%
1/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
44.4%
4/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
22.2%
2/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
22.2%
2/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
22.2%
2/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
33.3%
3/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
22.2%
2/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
9.1%
1/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Eye disorders
Eye irritation
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
General disorders
Application site oedema
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Investigations
Transaminases increased
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
11.1%
1/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
9.1%
1/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/17 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/5 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/6 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/9 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
9.1%
1/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
0.00%
0/11 • Non-SAEs and SAEs were collected from the start of study treatment until Day 40 for Part A, until Day 34 for Part B and from start of study treatment until Day 29 for Part C.
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who took at least 1 dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER