Trial Outcomes & Findings for A Two-part Study to Compare a Tablet and Capsule Formulation of GSK2838232 With and Without Food, and to Assess the Safety and Drug Levels of Repeated Once-daily Doses of GSK2838232 Without Ritonavir (NCT NCT03234036)
NCT ID: NCT03234036
Last Updated: 2020-10-28
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet and capsule formulation in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
COMPLETED
PHASE1
26 participants
Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1
2020-10-28
Participant Flow
This two-part study assessed the relative bioavailability and food effect of a novel tablet formulation of boosted-GSK2838232 compared to capsule along with safety and pharmacokinetics of repeated once-daily doses of non-boosted GSK2838232. This study was conducted at a single center in the United States.
Participants received GSK2838232 200 milligrams (mg)/ritonavir as capsule or tablet formulation in Part 1 and GSK2838232 500 mg or placebo in Part 2. A total number of 16 participants were enrolled in Part 1 of the study and 10 participants were enrolled in Part 2. In total, 26 participants were enrolled in the study.
Participant milestones
| Measure |
GSK2838232 Capsule Fed/Tablet Fed/Tablet Fasted With Ritonavir
Eligible participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule administered under fed conditions in treatment period 1 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fed conditions in treatment period 2 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. Treatment period 1 and 2 were separated by a wash-out period of 10 days. Treatment period 2 and 3 were separated by 15 days wash-out period.
|
GSK2838232 Tablet Fed/Capsule Fed/Tablet Fasted With Ritonavir
Eligible participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fed conditions in treatment period 1 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule administered under fed conditions in treatment period 2 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. Treatment period 1 and 2 were separated by a wash-out period of 10 days. Treatment period 2 and 3 were separated by 15 days wash-out period.
|
Part 2: Placebo
Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days.
|
Part 2: GSK2838232 500 mg Tablet Fed
Eligible participants received non-ritonavir boosted GSK2838232 500 mg, given as single daily doses in fed condition for 11 days.
|
|---|---|---|---|---|
|
Part 1: Treatment Period 1(Up to 7 Days)
STARTED
|
8
|
8
|
0
|
0
|
|
Part 1: Treatment Period 1(Up to 7 Days)
COMPLETED
|
8
|
8
|
0
|
0
|
|
Part 1: Treatment Period 1(Up to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1:Washout Period 1 (Up to 10 Days)
STARTED
|
8
|
8
|
0
|
0
|
|
Part 1:Washout Period 1 (Up to 10 Days)
COMPLETED
|
7
|
7
|
0
|
0
|
|
Part 1:Washout Period 1 (Up to 10 Days)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Part 1: Treatment Period 2(Up to 7 Days)
STARTED
|
7
|
7
|
0
|
0
|
|
Part 1: Treatment Period 2(Up to 7 Days)
COMPLETED
|
7
|
7
|
0
|
0
|
|
Part 1: Treatment Period 2(Up to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1:Washout Period 2 (Up to 15 Days)
STARTED
|
7
|
7
|
0
|
0
|
|
Part 1:Washout Period 2 (Up to 15 Days)
COMPLETED
|
7
|
7
|
0
|
0
|
|
Part 1:Washout Period 2 (Up to 15 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1:Treatment Period 3 (Up to 7 Days)
STARTED
|
7
|
7
|
0
|
0
|
|
Part 1:Treatment Period 3 (Up to 7 Days)
COMPLETED
|
7
|
7
|
0
|
0
|
|
Part 1:Treatment Period 3 (Up to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2 (Up to 25 Days)
STARTED
|
0
|
0
|
3
|
7
|
|
Part 2 (Up to 25 Days)
COMPLETED
|
0
|
0
|
3
|
7
|
|
Part 2 (Up to 25 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
GSK2838232 Capsule Fed/Tablet Fed/Tablet Fasted With Ritonavir
Eligible participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule administered under fed conditions in treatment period 1 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fed conditions in treatment period 2 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. Treatment period 1 and 2 were separated by a wash-out period of 10 days. Treatment period 2 and 3 were separated by 15 days wash-out period.
|
GSK2838232 Tablet Fed/Capsule Fed/Tablet Fasted With Ritonavir
Eligible participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fed conditions in treatment period 1 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule administered under fed conditions in treatment period 2 along with ritonavir 100 mg tablet to be taken with water in fed condition, followed by a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition. Treatment period 1 and 2 were separated by a wash-out period of 10 days. Treatment period 2 and 3 were separated by 15 days wash-out period.
|
Part 2: Placebo
Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days.
|
Part 2: GSK2838232 500 mg Tablet Fed
Eligible participants received non-ritonavir boosted GSK2838232 500 mg, given as single daily doses in fed condition for 11 days.
|
|---|---|---|---|---|
|
Part 1:Washout Period 1 (Up to 10 Days)
Adverse Event
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Two-part Study to Compare a Tablet and Capsule Formulation of GSK2838232 With and Without Food, and to Assess the Safety and Drug Levels of Repeated Once-daily Doses of GSK2838232 Without Ritonavir
Baseline characteristics by cohort
| Measure |
Part 1: All Participants Receiving GSK2838232/Ritonavir
n=16 Participants
Eligible participants were assigned to treatment sequence AB or BA where A=single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule under fed condition and B=single dose of GSK2838232 200 mg (as 4 x 50 mg) tablet formulations administered under fed condition in treatment periods 1 and 2 along with ritonavir 100 mg to be taken with water in fed condition. Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet administered under fasted conditions in treatment period 3 along with ritonavir 100 mg to be taken with water in fasted condition. Treatment periods 1 and 2 were separated by a wash-out period of 10 days. Treatment periods 2 and 3 were separated by a wash-out period of 15 days.
|
Part 2: Placebo
n=3 Participants
Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days.
|
Part 2: GSK2838232 500 mg Tablet Fed
n=7 Participants
Eligible participants received non-ritonavir boosted GSK2838232 500 mg, given as single daily doses in fed condition for 11 days.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.3 Years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
41.0 Years
STANDARD_DEVIATION 9.64 • n=7 Participants
|
34.6 Years
STANDARD_DEVIATION 7.81 • n=5 Participants
|
36.38 Years
STANDARD_DEVIATION 9.30 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
MULTIPLE-ASIAN & BLACK OR AFRICAN AMERICAN
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet and capsule formulation in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable \[NQ\] values were considered as non-missing values).
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State
|
4672.28 Hours*nanogram per milliliter
Geometric Coefficient of Variation 40.68
|
4437.98 Hours*nanogram per milliliter
Geometric Coefficient of Variation 30.83
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet and capsule formulation in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State
|
109.054 Nanograms per milliliter
Geometric Coefficient of Variation 48.01
|
118.118 Nanograms per milliliter
Geometric Coefficient of Variation 27.59
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: AUC (0-infinity) Following Administration of GSK2838232 Tablet in Fasted and Fed State
|
4437.98 Hours*nanogram per milliliter
Geometric Coefficient of Variation 30.83
|
1816.27 Hours*nanogram per milliliter
Geometric Coefficient of Variation 36.42
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Cmax Following Administration of GSK2838232 Tablet in Fasted and Fed State
|
118.118 Nanograms per milliliter
Geometric Coefficient of Variation 27.59
|
50.437 Nanograms per milliliter
Geometric Coefficient of Variation 35.61
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Time of Occurrence of Cmax (Tmax) Following Administration of GSK2838232 Tablet in Fasted and Fed State
|
5.983 Hours
Interval 2.0 to 24.03
|
3.508 Hours
Interval 2.0 to 11.97
|
—
|
PRIMARY outcome
Timeframe: Up to 25 daysPopulation: Safety Population
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect, is associated with liver injury or impaired liver function or any other situations as per medical or scientific judgment. Safety Population comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment. Number of participants with SAEs and common non-SAEs (\>=5%) are presented.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
Any SAE
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
Any non-SAE
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 25 daysPopulation: Safety Population
Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were \< 0.075 or \>0.54 proportion of red blood cells in blood for hematocrit, \<25 or \>180 grams per liter (g/L) for hemoglobin, \< 3 or \>20 cells per liter (cells/L) for leukocytes, 0.8 x10\^9 cells/L for lymphocytes, 1.5 x10\^9 cells/L for neutrophils, and \<100 or \>550 cells/L for platelets. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (example given \[e.g.\], High to High), or whose value became within range, were recorded in the "To within Range or No Change" category.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Hematocrit; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Leukocytes; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Lymphocytes; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Lymphocytes; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Neutrophils; To Low
|
1 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Platelets; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Lymphocytes; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Hematocrit; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Hematocrit; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Hemoglobin; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Hemoglobin; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Hemoglobin; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Leukocytes; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Leukocytes; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Neutrophils; To within Range or No Change
|
2 Participants
|
6 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Neutrophils; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Platelets; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria
Platelets; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 25 daysPopulation: Safety Population
Blood samples were collected from participants for analysis of following clinical chemistry parameters; glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, calcium, potassium and sodium. PCI ranges were \<30 g/L for albumin, \<2 or \>2.75 millimoles per liter (mmol/L) for calcium, \<3 or \>9 mmol/L for glucose, \>=2 times Upper limit of Normal (ULN) units per liter (U/L) for ALT, \>=2 times ULN U/L for alkaline phosphatase, \>=2 times ULN U/L for AST, \>=1.5 times ULN micromoles per liter (µmol/L) for bilirubin, \<3 or \>5.5 mmol/L for potassium, and \<130 or \>150 mmol/L for sodium. Participants were counted in the worst case category that their value changes to (low, within range or no change,or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
ALT; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Glucose; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Glucose; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Glucose; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
ALT; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
ALT; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Albumin; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Albumin; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Albumin; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Alkaline phosphatase; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Alkaline phosphatase; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Alkaline phosphatase; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
AST; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
AST; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
AST; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Bilirubin; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Bilirubin; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Bilirubin; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Calcium; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Calcium; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Calcium; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Potassium; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Potassium; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Potassium; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Sodium; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Sodium; To within Range or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Sodium; To High
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 25 daysPopulation: Safety Population
Urine samples were collected from participants for analysis of following urinalysis parameters; specific gravity, potential of hydrogen (pH), presence of glucose, protein, occult blood, ketones in urine analyzed by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the "To Normal or No Change" category.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Glucose; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Glucose; To Normal or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Glucose; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Glucose; To Abnormal
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Ketones; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Ketones; To Normal or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Ketones; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Ketones; To Abnormal
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Occult blood; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Occult blood; To Normal or No Change
|
2 Participants
|
6 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Occult blood; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Occult blood; To Abnormal
|
1 Participants
|
1 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Protein; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Protein; To Normal or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Protein; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Protein; To Abnormal
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Specific gravity; To Low
|
1 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Specific gravity; To Normal or No Change
|
2 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Specific gravity; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Specific gravity; To Abnormal
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine pH; To Low
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine pH; To Normal or No Change
|
3 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine pH; To High
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine pH; To Abnormal
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day -1; Pre-dose, 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)Population: Safety Population
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in supine position after 10 minutes rest for the participants at indicated time points.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 9
|
107.333 Millimeter of mercury
Standard Deviation 7.2342
|
110.143 Millimeter of mercury
Standard Deviation 8.7069
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 10
|
110.000 Millimeter of mercury
Standard Deviation 4.0000
|
106.714 Millimeter of mercury
Standard Deviation 8.8828
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 11, PREDOSE
|
107.113 Millimeter of mercury
Standard Deviation 3.8626
|
110.333 Millimeter of mercury
Standard Deviation 9.7088
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY -1
|
73.667 Millimeter of mercury
Standard Deviation 7.5056
|
73.143 Millimeter of mercury
Standard Deviation 4.7759
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 1, PREDOSE
|
65.443 Millimeter of mercury
Standard Deviation 2.6925
|
72.333 Millimeter of mercury
Standard Deviation 8.1636
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 1, 1 Hour
|
54.667 Millimeter of mercury
Standard Deviation 3.7859
|
64.714 Millimeter of mercury
Standard Deviation 5.8228
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 1, 4 Hours
|
62.000 Millimeter of mercury
Standard Deviation 1.0000
|
63.714 Millimeter of mercury
Standard Deviation 6.7507
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 2, 24 Hours
|
73.667 Millimeter of mercury
Standard Deviation 4.0415
|
73.714 Millimeter of mercury
Standard Deviation 6.0474
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 3, 48 Hours
|
66.000 Millimeter of mercury
Standard Deviation 1.7321
|
68.000 Millimeter of mercury
Standard Deviation 7.3485
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 4, 72 Hours
|
69.000 Millimeter of mercury
Standard Deviation 2.6458
|
65.143 Millimeter of mercury
Standard Deviation 8.3552
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 5
|
62.333 Millimeter of mercury
Standard Deviation 4.9329
|
65.000 Millimeter of mercury
Standard Deviation 7.3258
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 6
|
62.667 Millimeter of mercury
Standard Deviation 4.5092
|
66.143 Millimeter of mercury
Standard Deviation 6.6690
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 7
|
64.333 Millimeter of mercury
Standard Deviation 3.0551
|
67.286 Millimeter of mercury
Standard Deviation 4.8892
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 8
|
66.000 Millimeter of mercury
Standard Deviation 2.6458
|
69.286 Millimeter of mercury
Standard Deviation 6.3957
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 9
|
69.000 Millimeter of mercury
Standard Deviation 4.0000
|
66.714 Millimeter of mercury
Standard Deviation 5.0568
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 10
|
65.000 Millimeter of mercury
Standard Deviation 7.2111
|
66.571 Millimeter of mercury
Standard Deviation 8.0593
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 11, PREDOSE
|
65.333 Millimeter of mercury
Standard Deviation 5.1316
|
67.000 Millimeter of mercury
Standard Deviation 8.0179
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 11, 1 Hour
|
62.667 Millimeter of mercury
Standard Deviation 7.3711
|
66.571 Millimeter of mercury
Standard Deviation 7.6563
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 11, 4 Hours
|
63.333 Millimeter of mercury
Standard Deviation 4.5092
|
65.571 Millimeter of mercury
Standard Deviation 8.5021
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 11, 24 Hours
|
67.667 Millimeter of mercury
Standard Deviation 4.5092
|
64.714 Millimeter of mercury
Standard Deviation 7.0643
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 11, 48 Hours
|
66.000 Millimeter of mercury
Standard Deviation 5.5678
|
68.000 Millimeter of mercury
Standard Deviation 8.9815
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; DAY 11, 72 Hours
|
66.333 Millimeter of mercury
Standard Deviation 3.7859
|
65.000 Millimeter of mercury
Standard Deviation 5.8878
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
DBP; Follow-Up (DAY 25)
|
71.000 Millimeter of mercury
Standard Deviation 1.0000
|
76.143 Millimeter of mercury
Standard Deviation 10.5424
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY -1
|
121.000 Millimeter of mercury
Standard Deviation 4.5826
|
123.000 Millimeter of mercury
Standard Deviation 7.3258
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 1, PREDOSE
|
107.553 Millimeter of mercury
Standard Deviation 4.1400
|
121.190 Millimeter of mercury
Standard Deviation 10.8374
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 8
|
105.667 Millimeter of mercury
Standard Deviation 4.1633
|
109.571 Millimeter of mercury
Standard Deviation 6.2412
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 1, 1 Hour
|
99.333 Millimeter of mercury
Standard Deviation 2.0817
|
113.000 Millimeter of mercury
Standard Deviation 8.7178
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 1, 4 Hours
|
105.000 Millimeter of mercury
Standard Deviation 8.1854
|
106.286 Millimeter of mercury
Standard Deviation 9.6214
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 2, 24 Hours
|
110.667 Millimeter of mercury
Standard Deviation 7.7675
|
113.286 Millimeter of mercury
Standard Deviation 5.0568
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 3, 48 Hours
|
111.333 Millimeter of mercury
Standard Deviation 2.3094
|
111.714 Millimeter of mercury
Standard Deviation 8.7695
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 4, 72 Hours
|
108.333 Millimeter of mercury
Standard Deviation 7.6376
|
109.000 Millimeter of mercury
Standard Deviation 8.2260
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 5
|
105.667 Millimeter of mercury
Standard Deviation 2.3094
|
109.000 Millimeter of mercury
Standard Deviation 3.0551
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 6
|
106.667 Millimeter of mercury
Standard Deviation 4.7258
|
107.857 Millimeter of mercury
Standard Deviation 9.0079
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 7
|
103.333 Millimeter of mercury
Standard Deviation 1.1547
|
112.143 Millimeter of mercury
Standard Deviation 8.6106
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 11, 1 Hour
|
113.000 Millimeter of mercury
Standard Deviation 3.4641
|
111.571 Millimeter of mercury
Standard Deviation 15.7041
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 11, 4 Hours
|
108.667 Millimeter of mercury
Standard Deviation 6.0277
|
109.857 Millimeter of mercury
Standard Deviation 8.7069
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 11, 24 Hours
|
107.333 Millimeter of mercury
Standard Deviation 13.2035
|
105.143 Millimeter of mercury
Standard Deviation 7.7337
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 11, 48 Hours
|
109.667 Millimeter of mercury
Standard Deviation 8.0829
|
109.286 Millimeter of mercury
Standard Deviation 8.8828
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; DAY 11, 72 Hours
|
110.333 Millimeter of mercury
Standard Deviation 2.3094
|
110.286 Millimeter of mercury
Standard Deviation 7.6966
|
—
|
|
Part 2: Blood Pressure at Indicated Time Points
SBP; Follow-Up (DAY 25)
|
115.667 Millimeter of mercury
Standard Deviation 5.8595
|
123.714 Millimeter of mercury
Standard Deviation 10.6413
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)Population: Safety Population
SBP and DBP were measured in supine position after 10 minutes rest for participants at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 1, 1 Hour
|
-10.777 Millimeter of mercury
Standard Deviation 4.6690
|
-7.619 Millimeter of mercury
Standard Deviation 4.9086
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 1, 4 Hours
|
-3.443 Millimeter of mercury
Standard Deviation 3.6851
|
-8.619 Millimeter of mercury
Standard Deviation 9.3099
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 2, 24 Hours
|
8.223 Millimeter of mercury
Standard Deviation 2.5455
|
1.381 Millimeter of mercury
Standard Deviation 5.6866
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 3, 48 Hours
|
0.557 Millimeter of mercury
Standard Deviation 4.3485
|
-4.333 Millimeter of mercury
Standard Deviation 8.5244
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 4, 72 Hours
|
3.557 Millimeter of mercury
Standard Deviation 2.2180
|
-7.190 Millimeter of mercury
Standard Deviation 8.9524
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 5
|
-3.110 Millimeter of mercury
Standard Deviation 2.8366
|
-7.333 Millimeter of mercury
Standard Deviation 10.9039
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 6
|
-2.777 Millimeter of mercury
Standard Deviation 3.7175
|
-6.190 Millimeter of mercury
Standard Deviation 7.8255
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 7
|
-1.110 Millimeter of mercury
Standard Deviation 4.4381
|
-5.047 Millimeter of mercury
Standard Deviation 8.9388
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 8
|
0.557 Millimeter of mercury
Standard Deviation 0.5095
|
-3.047 Millimeter of mercury
Standard Deviation 9.4939
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 9
|
3.557 Millimeter of mercury
Standard Deviation 5.5901
|
-5.619 Millimeter of mercury
Standard Deviation 8.5770
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 10
|
-0.443 Millimeter of mercury
Standard Deviation 5.3488
|
-5.761 Millimeter of mercury
Standard Deviation 10.0756
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 11, PREDOSE
|
-0.110 Millimeter of mercury
Standard Deviation 3.4708
|
-5.333 Millimeter of mercury
Standard Deviation 11.3081
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 11, 1 Hour
|
-2.777 Millimeter of mercury
Standard Deviation 5.3385
|
-5.761 Millimeter of mercury
Standard Deviation 12.2366
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 11, 4 Hours
|
-2.110 Millimeter of mercury
Standard Deviation 3.3729
|
-6.761 Millimeter of mercury
Standard Deviation 10.3364
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 11, 24 Hours
|
2.223 Millimeter of mercury
Standard Deviation 5.9279
|
-7.619 Millimeter of mercury
Standard Deviation 10.1445
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 11, 48 Hours
|
0.557 Millimeter of mercury
Standard Deviation 6.7022
|
-4.333 Millimeter of mercury
Standard Deviation 9.7243
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; DAY 11, 72 Hours
|
0.890 Millimeter of mercury
Standard Deviation 4.6224
|
-7.333 Millimeter of mercury
Standard Deviation 9.2678
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
DBP; Follow-Up (DAY 25)
|
5.557 Millimeter of mercury
Standard Deviation 3.2015
|
3.810 Millimeter of mercury
Standard Deviation 10.1939
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 1, 1 Hour
|
-8.220 Millimeter of mercury
Standard Deviation 3.0060
|
-8.190 Millimeter of mercury
Standard Deviation 10.8776
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 1, 4 Hours
|
-2.553 Millimeter of mercury
Standard Deviation 5.6718
|
-14.904 Millimeter of mercury
Standard Deviation 8.2260
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 2, 24 Hours
|
3.113 Millimeter of mercury
Standard Deviation 5.8232
|
-7.904 Millimeter of mercury
Standard Deviation 8.7636
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 3, 48 Hours
|
3.780 Millimeter of mercury
Standard Deviation 1.8347
|
-9.476 Millimeter of mercury
Standard Deviation 6.2626
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 4, 72 Hours
|
0.780 Millimeter of mercury
Standard Deviation 5.4181
|
-12.190 Millimeter of mercury
Standard Deviation 7.1567
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 5
|
-1.887 Millimeter of mercury
Standard Deviation 3.6851
|
-12.190 Millimeter of mercury
Standard Deviation 11.9632
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 6
|
-0.887 Millimeter of mercury
Standard Deviation 7.0661
|
-13.333 Millimeter of mercury
Standard Deviation 15.5386
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 7
|
-4.220 Millimeter of mercury
Standard Deviation 3.7452
|
-9.047 Millimeter of mercury
Standard Deviation 13.8084
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 8
|
-1.887 Millimeter of mercury
Standard Deviation 5.1225
|
-11.619 Millimeter of mercury
Standard Deviation 11.8726
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 9
|
-0.220 Millimeter of mercury
Standard Deviation 6.1657
|
-11.047 Millimeter of mercury
Standard Deviation 14.9222
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 10
|
2.447 Millimeter of mercury
Standard Deviation 7.8192
|
-14.476 Millimeter of mercury
Standard Deviation 13.8688
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 11, PREDOSE
|
-0.440 Millimeter of mercury
Standard Deviation 4.4381
|
-10.857 Millimeter of mercury
Standard Deviation 13.9763
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 11, 1 Hour
|
5.447 Millimeter of mercury
Standard Deviation 6.6678
|
-9.619 Millimeter of mercury
Standard Deviation 19.6856
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 11, 4 Hours
|
1.113 Millimeter of mercury
Standard Deviation 2.6962
|
-11.333 Millimeter of mercury
Standard Deviation 14.3479
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 11, 24 Hours
|
-0.220 Millimeter of mercury
Standard Deviation 13.2912
|
-16.047 Millimeter of mercury
Standard Deviation 15.2791
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 11, 48 Hours
|
2.113 Millimeter of mercury
Standard Deviation 12.0648
|
-11.904 Millimeter of mercury
Standard Deviation 11.8344
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; DAY 11, 72 Hours
|
2.780 Millimeter of mercury
Standard Deviation 1.8347
|
-10.904 Millimeter of mercury
Standard Deviation 13.1590
|
—
|
|
Part 2: Change From Baseline in Blood Pressure
SBP; Follow-Up (DAY 25)
|
8.113 Millimeter of mercury
Standard Deviation 4.6808
|
2.524 Millimeter of mercury
Standard Deviation 10.1553
|
—
|
PRIMARY outcome
Timeframe: Day -1; Pre-dose, 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)Population: Safety Population
Pulse rate of participants was measured in supine position after 10 minutes rest at indicated time points.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 11, 72 Hours
|
63.000 Beats per minute
Standard Deviation 2.6458
|
60.857 Beats per minute
Standard Deviation 3.9340
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY -1
|
63.667 Beats per minute
Standard Deviation 12.4231
|
64.143 Beats per minute
Standard Deviation 11.7817
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 1, PREDOSE
|
63.663 Beats per minute
Standard Deviation 4.0415
|
63.714 Beats per minute
Standard Deviation 11.3991
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 1, 1 Hour
|
68.000 Beats per minute
Standard Deviation 8.5440
|
72.286 Beats per minute
Standard Deviation 7.5214
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 1, 4 Hours
|
64.667 Beats per minute
Standard Deviation 3.0551
|
66.000 Beats per minute
Standard Deviation 10.1160
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 2, 24 Hours
|
57.667 Beats per minute
Standard Deviation 2.8868
|
58.286 Beats per minute
Standard Deviation 8.7123
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 3, 48 Hours
|
58.000 Beats per minute
Standard Deviation 2.6458
|
59.429 Beats per minute
Standard Deviation 7.9762
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 4, 72 Hours
|
58.667 Beats per minute
Standard Deviation 1.1547
|
58.286 Beats per minute
Standard Deviation 7.7613
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 5
|
60.667 Beats per minute
Standard Deviation 2.5166
|
66.429 Beats per minute
Standard Deviation 10.3900
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 6
|
62.333 Beats per minute
Standard Deviation 2.3094
|
59.143 Beats per minute
Standard Deviation 6.2564
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 7
|
59.333 Beats per minute
Standard Deviation 3.7859
|
63.429 Beats per minute
Standard Deviation 11.4143
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 8
|
64.333 Beats per minute
Standard Deviation 4.0415
|
62.000 Beats per minute
Standard Deviation 8.6795
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 9
|
61.000 Beats per minute
Standard Deviation 2.6458
|
60.714 Beats per minute
Standard Deviation 6.9693
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 10
|
63.667 Beats per minute
Standard Deviation 3.5119
|
60.143 Beats per minute
Standard Deviation 8.4346
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 11, PREDOSE
|
61.887 Beats per minute
Standard Deviation 1.3891
|
60.810 Beats per minute
Standard Deviation 9.3355
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 11, 1 Hour
|
72.667 Beats per minute
Standard Deviation 4.7258
|
70.143 Beats per minute
Standard Deviation 7.0102
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 11, 4 Hours
|
68.000 Beats per minute
Standard Deviation 5.2915
|
68.857 Beats per minute
Standard Deviation 8.4148
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 11, 24 Hours
|
67.667 Beats per minute
Standard Deviation 6.4291
|
64.571 Beats per minute
Standard Deviation 7.3679
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
DAY 11, 48 Hours
|
61.667 Beats per minute
Standard Deviation 6.5064
|
61.714 Beats per minute
Standard Deviation 4.6085
|
—
|
|
Part 2: Pulse Rate at Indicated Time Points
Follow-Up (DAY 25)
|
70.667 Beats per minute
Standard Deviation 8.0829
|
63.857 Beats per minute
Standard Deviation 9.4062
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)Population: Safety Population
Pulse rate was measured in supine position after 10 minutes rest at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Pulse Rate
DAY 1, 1 Hour
|
4.337 Beats per minute
Standard Deviation 11.2398
|
8.571 Beats per minute
Standard Deviation 5.4337
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 1, 4 Hours
|
1.003 Beats per minute
Standard Deviation 6.6583
|
2.286 Beats per minute
Standard Deviation 9.4965
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 2, 24 Hours
|
-5.997 Beats per minute
Standard Deviation 2.5166
|
-5.429 Beats per minute
Standard Deviation 4.4808
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 3, 48 Hours
|
-5.663 Beats per minute
Standard Deviation 4.9329
|
-4.286 Beats per minute
Standard Deviation 5.9568
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 4, 72 Hours
|
-4.997 Beats per minute
Standard Deviation 5.1316
|
-5.429 Beats per minute
Standard Deviation 7.0937
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 5
|
-2.997 Beats per minute
Standard Deviation 5.6862
|
2.714 Beats per minute
Standard Deviation 11.2383
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 6
|
-1.330 Beats per minute
Standard Deviation 4.3589
|
-4.571 Beats per minute
Standard Deviation 9.8771
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 7
|
-4.330 Beats per minute
Standard Deviation 1.0000
|
-0.286 Beats per minute
Standard Deviation 12.4265
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 8
|
0.670 Beats per minute
Standard Deviation 0.0000
|
-1.714 Beats per minute
Standard Deviation 8.2357
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 9
|
-2.663 Beats per minute
Standard Deviation 4.9329
|
-3.000 Beats per minute
Standard Deviation 9.7265
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 10
|
0.003 Beats per minute
Standard Deviation 7.5056
|
-3.571 Beats per minute
Standard Deviation 10.5886
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 11, PREDOSE
|
-1.777 Beats per minute
Standard Deviation 4.1400
|
-2.904 Beats per minute
Standard Deviation 10.5699
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 11, 1 Hour
|
9.003 Beats per minute
Standard Deviation 8.3865
|
6.429 Beats per minute
Standard Deviation 10.3760
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 11, 4 Hours
|
4.337 Beats per minute
Standard Deviation 8.5049
|
5.143 Beats per minute
Standard Deviation 10.9028
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 11, 24 Hours
|
4.003 Beats per minute
Standard Deviation 6.5064
|
0.857 Beats per minute
Standard Deviation 10.2185
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 11, 48 Hours
|
-1.997 Beats per minute
Standard Deviation 9.4516
|
-2.000 Beats per minute
Standard Deviation 9.6686
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
DAY 11, 72 Hours
|
-0.663 Beats per minute
Standard Deviation 4.0415
|
-2.857 Beats per minute
Standard Deviation 8.7974
|
—
|
|
Part 2: Change From Baseline in Pulse Rate
Follow-Up (DAY 25)
|
7.003 Beats per minute
Standard Deviation 11.9304
|
0.143 Beats per minute
Standard Deviation 10.7995
|
—
|
PRIMARY outcome
Timeframe: Day -1; 1, 4, 12 hours on Day 1; Days 2, 3, 5, 8; 1, 4, 12, 24 Hours on Day 11; Follow-up (Day 25)Population: Safety Population
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) 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.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 1, 1 Hour
|
2 Participants
|
4 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 1, 1 Hour
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 1, 4 Hours
|
2 Participants
|
6 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 1, 4 Hours
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 1, 12 Hours
|
3 Participants
|
6 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 1, 12 Hours
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 2
|
2 Participants
|
5 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 2
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 3
|
3 Participants
|
5 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 3
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 5
|
3 Participants
|
6 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 5
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 8
|
2 Participants
|
7 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 8
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 11, 1 Hour
|
2 Participants
|
3 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 11, 1 Hour
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 11, 4 Hours
|
2 Participants
|
5 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 11, 4 Hours
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 11, 12 Hours
|
2 Participants
|
4 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 11, 12 Hours
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY 11, 24 Hours
|
2 Participants
|
5 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY 11, 24 Hours
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: Follow-up (DAY 25)
|
1 Participants
|
6 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: Follow-up (DAY 25)
|
0 Participants
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCS: DAY -1
|
2 Participants
|
6 Participants
|
—
|
|
Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
CS: DAY -1
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and 1, 4, 12 hours on Day 1; Days 2, 3 5, 8; Pre-dose, 1, 4, 12, 24 hours Day 11; Follow-up (Day 25)Population: Safety Population
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 11, 4 Hours
|
1.000 Beats per minute
Standard Deviation 4.0986
|
4.811 Beats per minute
Standard Deviation 8.2683
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 11, 12 Hours
|
-0.667 Beats per minute
Standard Deviation 3.8461
|
-0.189 Beats per minute
Standard Deviation 5.6490
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 11, 24 Hours
|
2.667 Beats per minute
Standard Deviation 4.8106
|
0.954 Beats per minute
Standard Deviation 4.8878
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
Follow-up (DAY 25)
|
2.333 Beats per minute
Standard Deviation 12.4705
|
0.669 Beats per minute
Standard Deviation 8.2733
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 1 Hour
|
4.000 Beats per minute
Standard Deviation 10.1734
|
10.240 Beats per minute
Standard Deviation 5.0930
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 4 Hours
|
2.000 Beats per minute
Standard Deviation 5.9287
|
1.954 Beats per minute
Standard Deviation 3.9733
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 12 Hours
|
-6.000 Beats per minute
Standard Deviation 6.8912
|
0.526 Beats per minute
Standard Deviation 5.1336
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 2
|
-8.000 Beats per minute
Standard Deviation 0.8826
|
-5.331 Beats per minute
Standard Deviation 4.8861
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 3
|
-5.333 Beats per minute
Standard Deviation 5.4902
|
-1.046 Beats per minute
Standard Deviation 4.9332
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 5
|
-3.667 Beats per minute
Standard Deviation 2.6062
|
2.669 Beats per minute
Standard Deviation 11.9804
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 8
|
-2.000 Beats per minute
Standard Deviation 1.8571
|
0.954 Beats per minute
Standard Deviation 5.8978
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 11, PREDOSE
|
-4.333 Beats per minute
Standard Deviation 1.7670
|
-0.903 Beats per minute
Standard Deviation 6.9388
|
—
|
|
Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 11, 1 Hour
|
10.333 Beats per minute
Standard Deviation 7.7564
|
6.383 Beats per minute
Standard Deviation 5.9634
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and 1, 4, 12 hours on Day 1; Days 2, 3 5, 8; Pre-dose, 1, 4, 12, 24 hours Day 11; Follow-up (Day 25)Population: Safety Population
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates measures PR, QRS, QT and QTcF intervals. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=3 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 5
|
6.223 Milliseconds
Standard Deviation 9.1999
|
2.287 Milliseconds
Standard Deviation 9.5818
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 1 Hour
|
-7.110 Milliseconds
Standard Deviation 2.0360
|
-3.999 Milliseconds
Standard Deviation 10.6110
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 4 Hours
|
-6.443 Milliseconds
Standard Deviation 3.7945
|
-12.284 Milliseconds
Standard Deviation 13.9800
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 12 Hours
|
-0.443 Milliseconds
Standard Deviation 11.9348
|
3.430 Milliseconds
Standard Deviation 5.7511
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 2
|
4.890 Milliseconds
Standard Deviation 3.6695
|
3.716 Milliseconds
Standard Deviation 5.1471
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 3
|
1.557 Milliseconds
Standard Deviation 4.2847
|
4.573 Milliseconds
Standard Deviation 6.1252
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 8
|
6.223 Milliseconds
Standard Deviation 10.8609
|
7.430 Milliseconds
Standard Deviation 11.6897
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 11, PREDOSE
|
5.113 Milliseconds
Standard Deviation 10.1172
|
7.620 Milliseconds
Standard Deviation 5.5483
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 11, 1 Hour
|
-5.777 Milliseconds
Standard Deviation 7.3456
|
2.287 Milliseconds
Standard Deviation 5.2749
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 11, 4 Hours
|
-3.110 Milliseconds
Standard Deviation 10.8418
|
-0.570 Milliseconds
Standard Deviation 9.9657
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 11, 12 Hours
|
4.223 Milliseconds
Standard Deviation 12.6221
|
1.716 Milliseconds
Standard Deviation 9.4661
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 11, 24 Hours
|
2.890 Milliseconds
Standard Deviation 10.8418
|
3.144 Milliseconds
Standard Deviation 6.0321
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; Follow-up (DAY 25)
|
-10.443 Milliseconds
Standard Deviation 5.0039
|
2.001 Milliseconds
Standard Deviation 13.1373
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 1 Hour
|
3.330 Milliseconds
Standard Deviation 5.2915
|
-1.713 Milliseconds
Standard Deviation 3.3072
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 4 Hours
|
1.997 Milliseconds
Standard Deviation 4.6188
|
-1.713 Milliseconds
Standard Deviation 1.4322
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 12 Hours
|
6.663 Milliseconds
Standard Deviation 4.6188
|
1.716 Milliseconds
Standard Deviation 3.6295
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 2
|
1.330 Milliseconds
Standard Deviation 2.0000
|
0.287 Milliseconds
Standard Deviation 2.2711
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 3
|
2.663 Milliseconds
Standard Deviation 3.0551
|
-4.570 Milliseconds
Standard Deviation 5.8288
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 5
|
3.997 Milliseconds
Standard Deviation 4.1633
|
-1.999 Milliseconds
Standard Deviation 2.8532
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 8
|
-0.003 Milliseconds
Standard Deviation 1.1547
|
-3.141 Milliseconds
Standard Deviation 4.1578
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 11, PREDOSE
|
1.107 Milliseconds
Standard Deviation 4.3393
|
-0.570 Milliseconds
Standard Deviation 1.9401
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 11, 1 Hour
|
-0.003 Milliseconds
Standard Deviation 2.3094
|
-0.856 Milliseconds
Standard Deviation 5.1594
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 11, 4 Hours
|
-1.337 Milliseconds
Standard Deviation 1.1547
|
-2.570 Milliseconds
Standard Deviation 3.0890
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 11, 12 Hours
|
3.330 Milliseconds
Standard Deviation 3.4641
|
-0.856 Milliseconds
Standard Deviation 4.4676
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 11, 24 Hours
|
-1.337 Milliseconds
Standard Deviation 1.1547
|
-0.570 Milliseconds
Standard Deviation 3.7401
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; Follow-up (DAY 25)
|
1.997 Milliseconds
Standard Deviation 11.0151
|
1.716 Milliseconds
Standard Deviation 1.5811
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 1 Hour
|
-8.223 Milliseconds
Standard Deviation 18.0177
|
-26.094 Milliseconds
Standard Deviation 12.8322
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 4 Hours
|
-3.557 Milliseconds
Standard Deviation 9.7159
|
-11.523 Milliseconds
Standard Deviation 11.6047
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 12 Hours
|
18.443 Milliseconds
Standard Deviation 18.0654
|
-7.237 Milliseconds
Standard Deviation 15.5856
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 2
|
5.777 Milliseconds
Standard Deviation 4.0741
|
0.763 Milliseconds
Standard Deviation 9.3458
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 3
|
5.777 Milliseconds
Standard Deviation 18.7403
|
-8.951 Milliseconds
Standard Deviation 11.9189
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 5
|
-0.890 Milliseconds
Standard Deviation 8.9502
|
-10.666 Milliseconds
Standard Deviation 19.1883
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 8
|
1.110 Milliseconds
Standard Deviation 2.3378
|
-8.951 Milliseconds
Standard Deviation 14.2945
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 11, PREDOSE
|
5.553 Milliseconds
Standard Deviation 6.1963
|
-4.283 Milliseconds
Standard Deviation 13.7560
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 11, 1 Hour
|
-18.223 Milliseconds
Standard Deviation 12.2979
|
-28.380 Milliseconds
Standard Deviation 19.3087
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 11, 4 Hours
|
-8.223 Milliseconds
Standard Deviation 10.0299
|
-20.380 Milliseconds
Standard Deviation 17.7740
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 11, 12 Hours
|
5.777 Milliseconds
Standard Deviation 10.5451
|
-13.237 Milliseconds
Standard Deviation 13.1751
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 11, 24 Hours
|
-10.890 Milliseconds
Standard Deviation 12.6010
|
-13.523 Milliseconds
Standard Deviation 11.7381
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; Follow-up (DAY 25)
|
0.443 Milliseconds
Standard Deviation 26.9777
|
-3.237 Milliseconds
Standard Deviation 20.6284
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 1 Hour
|
-0.667 Milliseconds
Standard Deviation 6.3366
|
-5.857 Milliseconds
Standard Deviation 10.3146
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 4 Hours
|
1.000 Milliseconds
Standard Deviation 2.1838
|
-7.429 Milliseconds
Standard Deviation 7.1165
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 12 Hours
|
7.000 Milliseconds
Standard Deviation 8.2158
|
-6.286 Milliseconds
Standard Deviation 10.9182
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 2
|
-10.667 Milliseconds
Standard Deviation 4.6671
|
-10.143 Milliseconds
Standard Deviation 6.7366
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 3
|
-5.000 Milliseconds
Standard Deviation 7.6908
|
-10.714 Milliseconds
Standard Deviation 9.6264
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 5
|
-7.667 Milliseconds
Standard Deviation 4.1800
|
-6.286 Milliseconds
Standard Deviation 7.6605
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 8
|
-2.000 Milliseconds
Standard Deviation 2.0246
|
-6.714 Milliseconds
Standard Deviation 6.5305
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 11, PREDOSE
|
-2.887 Milliseconds
Standard Deviation 2.9150
|
-6.476 Milliseconds
Standard Deviation 5.7033
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 11, 1 Hour
|
1.000 Milliseconds
Standard Deviation 4.8434
|
-15.286 Milliseconds
Standard Deviation 11.1814
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 11, 4 Hours
|
-5.667 Milliseconds
Standard Deviation 6.1719
|
-11.000 Milliseconds
Standard Deviation 4.8767
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 11, 12 Hours
|
5.333 Milliseconds
Standard Deviation 3.8474
|
-12.571 Milliseconds
Standard Deviation 7.6845
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 11, 24 Hours
|
-5.667 Milliseconds
Standard Deviation 2.9652
|
-10.429 Milliseconds
Standard Deviation 7.7286
|
—
|
|
Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; Follow-up (DAY 25)
|
4.000 Milliseconds
Standard Deviation 5.8145
|
-2.571 Milliseconds
Standard Deviation 12.9581
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Area Under the Plasma Drug Concentration Time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Day 1
|
895.42 Hours*nanograms per milliliter
Geometric Coefficient of Variation 39.08
|
—
|
—
|
|
Part 2: Area Under the Plasma Drug Concentration Time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Day 11
|
1184.55 Hours*nanograms per milliliter
Geometric Coefficient of Variation 35.34
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Cmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Day 1
|
79.575 Nanograms per milliliter
Geometric Coefficient of Variation 45.69
|
—
|
—
|
|
Part 2: Cmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Day 11
|
94.239 Nanograms per milliliter
Geometric Coefficient of Variation 34.24
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Observed Concentration at the End of the Dosing Interval (Ctau) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Day 1
|
21.620 Nanograms per milliliter
Geometric Coefficient of Variation 42.51
|
—
|
—
|
|
Part 2: Observed Concentration at the End of the Dosing Interval (Ctau) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Day 11
|
27.668 Nanograms per milliliter
Geometric Coefficient of Variation 41.16
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Tmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Day 1
|
4.000 Hours
Interval 2.0 to 8.0
|
—
|
—
|
|
Part 2: Tmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State
Day 11
|
3.500 Hours
Interval 1.98 to 6.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 in Part 2Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Tlag is a time delay between drug administration and first observed concentration. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Lag-time (Tlag) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 1
|
0.500 Hours
Interval 0.0 to 1.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: AUC(0-infinity) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11
|
1816.34 Hours*nanograms per milliliter
Geometric Coefficient of Variation 37.32
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Apparent Terminal Phase Half-life (T1/2) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11
|
23.217 Hours
Geometric Coefficient of Variation 37.85
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Time of Last Quantifiable Concentration (Tlast) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11
|
118.800 Hours
Interval 95.1 to 118.85
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 60 daysPopulation: Safety Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect, is associated with liver injury or impaired liver function or any other situations as per medical or scientific judgment. Number of participants with SAEs and common non-SAEs (\>=5%) are presented.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Number of Participants With SAEs and Non-SAEs
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With SAEs and Non-SAEs
Any non-SAE
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 60 daysPopulation: Safety Population
Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were \>0.54 as proportion of red blood cells in blood for hematocrit, \>180 g/L for hemoglobin, \< 3 or \>20 cells/L for leukocytes, 0.8 x10\^9 cells/L for lymphocytes, 1.5 x10\^9 cells/L for neutrophils, and \<100 or \>550 cells/L for platelets. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Hematocrit; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Leukocytes; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Neutrophils; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Hematocrit; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Hematocrit; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Hemoglobin; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Hemoglobin; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Hemoglobin; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Leukocytes; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Leukocytes; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Lymphocytes; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Lymphocytes; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Lymphocytes; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Neutrophils; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Neutrophils; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Platelets; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Platelets; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria
Platelets; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 60 daysPopulation: Safety Population
Blood samples were collected from participants for analysis of following clinical chemistry parameters; glucose, ALT, albumin, alkaline phosphatase, AST, bilirubin, calcium, potassium and sodium. PCI ranges were \<30 g/L for albumin, \<2 or 2.75 mmol/L for calcium, \<3 or \>9 mmol/L for glucose, \>=2 times ULN U/L for ALT, \>=2 times ULN U/L for alkaline phosphatase, \>=2 times ULN U/L for AST, \>=1.5 times ULN µmol/L for bilirubin, \<3 or \>5.5 mmol/L for potassium, and \<130 or \>150 mmol/L for sodium. Participants were counted in the worst case category that their value changes to (low, within range or no change,or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the "To within Range or No Change" category.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Bilirubin; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Glucose; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Glucose; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Glucose; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
ALT; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
ALT; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
ALT; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Albumin; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Albumin; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Albumin; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Alkaline phosphatase; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Alkaline phosphatase; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Alkaline phosphatase; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
AST; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
AST; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
AST; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Bilirubin; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Bilirubin; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Calcium; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Calcium; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Calcium; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Potassium; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Sodium; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Potassium; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Potassium; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Sodium; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria
Sodium; To within Range or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 60 daysPopulation: Safety Population
Urine samples were collected from participants for analysis of following urinalysis parameters; specific gravity, pH, presence of glucose, protein, occult blood, ketones in urine analyzed by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the "To Normal or No Change" category.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Glucose; To Abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Specific gravity; To Low
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Glucose; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Glucose; To Normal or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Glucose; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Ketones; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Ketones; To Normal or No Change
|
14 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Ketones; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Ketones To Abnormal
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Occult blood; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Occult blood ; To Normal or No Change
|
14 Participants
|
13 Participants
|
10 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Occult blood; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Occult blood To Abnormal
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Protein; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Protein; To Normal or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Protein; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Protein To Abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Specific gravity; To Normal or No Change
|
14 Participants
|
15 Participants
|
12 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Specific gravity; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Specific gravity To Abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine pH; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine pH; To Normal or No Change
|
15 Participants
|
15 Participants
|
14 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine pH; To High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria
Urine pH; To Abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day -2; Day -1; Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1Population: Safety Population
SBP and DBP of participants were measured in supine position after 10 minutes rest at indicated time points.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY -1
|
110.067 Millimeter of mercury
Standard Deviation 10.2153
|
104.000 Millimeter of mercury
Standard Deviation 9.7980
|
108.429 Millimeter of mercury
Standard Deviation 11.1128
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY 1, PREDOSE
|
108.156 Millimeter of mercury
Standard Deviation 9.2400
|
108.289 Millimeter of mercury
Standard Deviation 11.1021
|
106.858 Millimeter of mercury
Standard Deviation 9.5900
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY -2
|
68.667 Millimeter of mercury
Standard Deviation 6.2981
|
69.533 Millimeter of mercury
Standard Deviation 7.6426
|
65.000 Millimeter of mercury
Standard Deviation 6.1893
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY -1
|
67.467 Millimeter of mercury
Standard Deviation 6.2320
|
68.467 Millimeter of mercury
Standard Deviation 8.7657
|
65.643 Millimeter of mercury
Standard Deviation 7.7619
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY 1, PREDOSE
|
65.956 Millimeter of mercury
Standard Deviation 4.9419
|
66.245 Millimeter of mercury
Standard Deviation 7.1653
|
66.929 Millimeter of mercury
Standard Deviation 7.4379
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY 1, 1 Hour
|
63.200 Millimeter of mercury
Standard Deviation 6.1551
|
64.133 Millimeter of mercury
Standard Deviation 6.1163
|
67.357 Millimeter of mercury
Standard Deviation 5.4998
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY 1, 2 Hours
|
62.133 Millimeter of mercury
Standard Deviation 5.6552
|
62.533 Millimeter of mercury
Standard Deviation 4.6425
|
66.071 Millimeter of mercury
Standard Deviation 7.1410
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY 1, 4 Hours
|
63.733 Millimeter of mercury
Standard Deviation 6.6490
|
64.400 Millimeter of mercury
Standard Deviation 5.3825
|
67.429 Millimeter of mercury
Standard Deviation 5.5152
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY 1, 6 Hours
|
64.400 Millimeter of mercury
Standard Deviation 6.1968
|
64.067 Millimeter of mercury
Standard Deviation 7.4878
|
66.071 Millimeter of mercury
Standard Deviation 5.5117
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY 1, 8 Hours
|
68.333 Millimeter of mercury
Standard Deviation 6.6940
|
66.933 Millimeter of mercury
Standard Deviation 5.0351
|
68.000 Millimeter of mercury
Standard Deviation 6.1269
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY 1, 12 Hours
|
68.867 Millimeter of mercury
Standard Deviation 5.5532
|
67.800 Millimeter of mercury
Standard Deviation 7.2723
|
66.214 Millimeter of mercury
Standard Deviation 5.1766
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY 1, 24 Hours
|
68.400 Millimeter of mercury
Standard Deviation 6.4343
|
66.533 Millimeter of mercury
Standard Deviation 6.2663
|
66.929 Millimeter of mercury
Standard Deviation 7.0870
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY 1, 48 Hours
|
66.600 Millimeter of mercury
Standard Deviation 7.4431
|
67.333 Millimeter of mercury
Standard Deviation 5.5377
|
64.643 Millimeter of mercury
Standard Deviation 6.1595
|
|
Part 1: Blood Pressure at Indicated Time Points
DBP; DAY 1, 72 Hours
|
66.600 Millimeter of mercury
Standard Deviation 8.0250
|
67.067 Millimeter of mercury
Standard Deviation 5.2026
|
64.429 Millimeter of mercury
Standard Deviation 7.1545
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY -2
|
108.667 Millimeter of mercury
Standard Deviation 9.9115
|
109.733 Millimeter of mercury
Standard Deviation 9.0116
|
105.786 Millimeter of mercury
Standard Deviation 9.8775
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY 1, 1 Hour
|
106.000 Millimeter of mercury
Standard Deviation 10.0428
|
108.400 Millimeter of mercury
Standard Deviation 8.3820
|
106.500 Millimeter of mercury
Standard Deviation 9.3377
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY 1, 2 Hours
|
104.867 Millimeter of mercury
Standard Deviation 10.6091
|
105.067 Millimeter of mercury
Standard Deviation 9.6323
|
106.214 Millimeter of mercury
Standard Deviation 11.8593
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY 1, 4 Hours
|
107.733 Millimeter of mercury
Standard Deviation 9.1844
|
106.000 Millimeter of mercury
Standard Deviation 8.8237
|
106.714 Millimeter of mercury
Standard Deviation 10.8019
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY 1, 6 Hours
|
108.333 Millimeter of mercury
Standard Deviation 8.9894
|
106.933 Millimeter of mercury
Standard Deviation 7.1661
|
108.214 Millimeter of mercury
Standard Deviation 11.8008
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY 1, 8 Hours
|
112.067 Millimeter of mercury
Standard Deviation 8.9639
|
110.600 Millimeter of mercury
Standard Deviation 12.3508
|
106.000 Millimeter of mercury
Standard Deviation 12.3973
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY 1, 12 Hours
|
110.133 Millimeter of mercury
Standard Deviation 10.2181
|
113.000 Millimeter of mercury
Standard Deviation 11.9762
|
107.786 Millimeter of mercury
Standard Deviation 12.1919
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY 1, 24 Hours
|
106.200 Millimeter of mercury
Standard Deviation 9.9441
|
107.467 Millimeter of mercury
Standard Deviation 10.8619
|
105.500 Millimeter of mercury
Standard Deviation 11.1061
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY 1, 48 Hours
|
106.867 Millimeter of mercury
Standard Deviation 10.1620
|
107.067 Millimeter of mercury
Standard Deviation 6.3860
|
102.000 Millimeter of mercury
Standard Deviation 12.2725
|
|
Part 1: Blood Pressure at Indicated Time Points
SBP; DAY 1, 72 Hours
|
104.067 Millimeter of mercury
Standard Deviation 11.7075
|
105.933 Millimeter of mercury
Standard Deviation 10.8197
|
107.429 Millimeter of mercury
Standard Deviation 13.5290
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1Population: Safety Population
SBP and DBP were measured in supine position after 10 minutes rest for the participant at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Blood Pressure
DBP; DAY 1, 1 Hour
|
-2.756 Millimeter of mercury
Standard Deviation 4.5583
|
-2.112 Millimeter of mercury
Standard Deviation 5.8242
|
0.429 Millimeter of mercury
Standard Deviation 6.2950
|
|
Part 1: Change From Baseline in Blood Pressure
DBP; DAY 1, 2 Hours
|
-3.823 Millimeter of mercury
Standard Deviation 4.8274
|
-3.712 Millimeter of mercury
Standard Deviation 7.5868
|
-0.857 Millimeter of mercury
Standard Deviation 6.0936
|
|
Part 1: Change From Baseline in Blood Pressure
DBP; DAY 1, 4 Hours
|
-2.223 Millimeter of mercury
Standard Deviation 5.1037
|
-1.845 Millimeter of mercury
Standard Deviation 6.6186
|
0.500 Millimeter of mercury
Standard Deviation 4.4191
|
|
Part 1: Change From Baseline in Blood Pressure
DBP; DAY 1, 6 Hours
|
-1.556 Millimeter of mercury
Standard Deviation 4.0795
|
-2.179 Millimeter of mercury
Standard Deviation 5.8416
|
-0.857 Millimeter of mercury
Standard Deviation 6.7412
|
|
Part 1: Change From Baseline in Blood Pressure
DBP; DAY 1, 8 Hours
|
2.377 Millimeter of mercury
Standard Deviation 3.8999
|
0.688 Millimeter of mercury
Standard Deviation 7.8368
|
1.071 Millimeter of mercury
Standard Deviation 4.3963
|
|
Part 1: Change From Baseline in Blood Pressure
DBP; DAY 1, 12 Hours
|
2.911 Millimeter of mercury
Standard Deviation 6.7287
|
1.555 Millimeter of mercury
Standard Deviation 7.1028
|
-0.714 Millimeter of mercury
Standard Deviation 6.2782
|
|
Part 1: Change From Baseline in Blood Pressure
DBP; DAY 1, 24 Hours
|
2.444 Millimeter of mercury
Standard Deviation 4.7072
|
0.288 Millimeter of mercury
Standard Deviation 6.5408
|
0.000 Millimeter of mercury
Standard Deviation 6.3519
|
|
Part 1: Change From Baseline in Blood Pressure
DBP; DAY 1, 48 Hours
|
0.644 Millimeter of mercury
Standard Deviation 7.9350
|
1.088 Millimeter of mercury
Standard Deviation 8.1406
|
-2.286 Millimeter of mercury
Standard Deviation 4.2171
|
|
Part 1: Change From Baseline in Blood Pressure
DBP; DAY 1, 72 Hours
|
0.644 Millimeter of mercury
Standard Deviation 6.4814
|
0.821 Millimeter of mercury
Standard Deviation 6.3773
|
-2.500 Millimeter of mercury
Standard Deviation 7.5579
|
|
Part 1: Change From Baseline in Blood Pressure
SBP; DAY 1, 1 Hour
|
-2.156 Millimeter of mercury
Standard Deviation 5.2225
|
0.111 Millimeter of mercury
Standard Deviation 8.8653
|
-0.358 Millimeter of mercury
Standard Deviation 7.2826
|
|
Part 1: Change From Baseline in Blood Pressure
SBP; DAY 1, 2 Hours
|
-3.289 Millimeter of mercury
Standard Deviation 8.9001
|
-3.222 Millimeter of mercury
Standard Deviation 11.2680
|
-0.644 Millimeter of mercury
Standard Deviation 6.9132
|
|
Part 1: Change From Baseline in Blood Pressure
SBP; DAY 1, 4 Hours
|
-0.423 Millimeter of mercury
Standard Deviation 7.3588
|
-2.289 Millimeter of mercury
Standard Deviation 10.0523
|
-0.144 Millimeter of mercury
Standard Deviation 8.8536
|
|
Part 1: Change From Baseline in Blood Pressure
SBP; DAY 1, 6 Hours
|
0.177 Millimeter of mercury
Standard Deviation 6.2989
|
-1.355 Millimeter of mercury
Standard Deviation 8.9097
|
1.356 Millimeter of mercury
Standard Deviation 9.9739
|
|
Part 1: Change From Baseline in Blood Pressure
SBP; DAY 1, 8 Hours
|
3.911 Millimeter of mercury
Standard Deviation 7.8095
|
2.311 Millimeter of mercury
Standard Deviation 11.0679
|
-0.858 Millimeter of mercury
Standard Deviation 10.0987
|
|
Part 1: Change From Baseline in Blood Pressure
SBP; DAY 1, 12 Hours
|
1.977 Millimeter of mercury
Standard Deviation 6.7186
|
4.711 Millimeter of mercury
Standard Deviation 7.4998
|
0.928 Millimeter of mercury
Standard Deviation 9.8279
|
|
Part 1: Change From Baseline in Blood Pressure
SBP; DAY 1, 24 Hours
|
-1.956 Millimeter of mercury
Standard Deviation 7.9095
|
-0.822 Millimeter of mercury
Standard Deviation 9.2810
|
-1.358 Millimeter of mercury
Standard Deviation 4.6289
|
|
Part 1: Change From Baseline in Blood Pressure
SBP; DAY 1, 48 Hours
|
-1.289 Millimeter of mercury
Standard Deviation 4.9058
|
-1.222 Millimeter of mercury
Standard Deviation 10.7458
|
-4.858 Millimeter of mercury
Standard Deviation 9.5294
|
|
Part 1: Change From Baseline in Blood Pressure
SBP; DAY 1, 72 Hours
|
-4.089 Millimeter of mercury
Standard Deviation 7.4727
|
-2.355 Millimeter of mercury
Standard Deviation 9.9198
|
0.571 Millimeter of mercury
Standard Deviation 11.2671
|
SECONDARY outcome
Timeframe: Day -2; Day -1; Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1Population: Safety Population
Pulse rate was measured in supine position after 10 minutes rest for the participant at indicated time points.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Pulse Rate at Indicated Time Points
DAY 1, 8 Hours
|
66.533 Beats per minute
Standard Deviation 10.5144
|
66.933 Beats per minute
Standard Deviation 7.2552
|
63.571 Beats per minute
Standard Deviation 10.6027
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY -2
|
64.067 Beats per minute
Standard Deviation 14.6066
|
62.333 Beats per minute
Standard Deviation 10.8737
|
60.214 Beats per minute
Standard Deviation 9.4558
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY -1
|
62.333 Beats per minute
Standard Deviation 10.6212
|
63.067 Beats per minute
Standard Deviation 7.6108
|
59.071 Beats per minute
Standard Deviation 10.6516
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY 1, PREDOSE
|
65.023 Beats per minute
Standard Deviation 10.7156
|
64.311 Beats per minute
Standard Deviation 7.9777
|
59.857 Beats per minute
Standard Deviation 8.3402
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY 1, 1 Hour
|
74.667 Beats per minute
Standard Deviation 8.5996
|
72.333 Beats per minute
Standard Deviation 9.2711
|
58.571 Beats per minute
Standard Deviation 9.3949
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY 1, 2 Hours
|
72.667 Beats per minute
Standard Deviation 11.8301
|
72.933 Beats per minute
Standard Deviation 9.5877
|
60.214 Beats per minute
Standard Deviation 10.4010
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY 1, 4 Hours
|
68.133 Beats per minute
Standard Deviation 7.8728
|
69.467 Beats per minute
Standard Deviation 11.0574
|
61.214 Beats per minute
Standard Deviation 9.5287
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY 1, 6 Hours
|
68.867 Beats per minute
Standard Deviation 9.9417
|
68.133 Beats per minute
Standard Deviation 11.0961
|
66.500 Beats per minute
Standard Deviation 9.4360
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY 1, 12 Hours
|
64.867 Beats per minute
Standard Deviation 9.0069
|
65.867 Beats per minute
Standard Deviation 6.4128
|
67.143 Beats per minute
Standard Deviation 11.4546
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY 1, 24 Hours
|
63.400 Beats per minute
Standard Deviation 7.1992
|
61.267 Beats per minute
Standard Deviation 7.6295
|
64.071 Beats per minute
Standard Deviation 11.5190
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY 1, 48 Hours
|
64.333 Beats per minute
Standard Deviation 6.7259
|
63.533 Beats per minute
Standard Deviation 6.4572
|
63.286 Beats per minute
Standard Deviation 10.5278
|
|
Part 1: Pulse Rate at Indicated Time Points
DAY 1, 72 Hours
|
62.267 Beats per minute
Standard Deviation 6.9639
|
62.467 Beats per minute
Standard Deviation 8.0166
|
62.286 Beats per minute
Standard Deviation 11.0900
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1Population: Safety Population
Pulse rate was measured in supine position after 10 minutes rest for the participant at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Pulse Rate
DAY 1, 1 Hour
|
9.644 Beats per minute
Standard Deviation 9.2897
|
8.023 Beats per minute
Standard Deviation 9.3536
|
-1.286 Beats per minute
Standard Deviation 4.4390
|
|
Part 1: Change From Baseline in Pulse Rate
DAY 1, 2 Hours
|
7.644 Beats per minute
Standard Deviation 10.5927
|
8.623 Beats per minute
Standard Deviation 8.8718
|
0.357 Beats per minute
Standard Deviation 5.2912
|
|
Part 1: Change From Baseline in Pulse Rate
DAY 1, 4 Hours
|
3.111 Beats per minute
Standard Deviation 7.1157
|
5.156 Beats per minute
Standard Deviation 10.5863
|
1.357 Beats per minute
Standard Deviation 4.6853
|
|
Part 1: Change From Baseline in Pulse Rate
DAY 1, 6 Hours
|
3.844 Beats per minute
Standard Deviation 8.0953
|
3.823 Beats per minute
Standard Deviation 11.4959
|
6.643 Beats per minute
Standard Deviation 2.4580
|
|
Part 1: Change From Baseline in Pulse Rate
DAY 1, 8 Hours
|
1.511 Beats per minute
Standard Deviation 9.0965
|
2.623 Beats per minute
Standard Deviation 9.1496
|
3.714 Beats per minute
Standard Deviation 5.1408
|
|
Part 1: Change From Baseline in Pulse Rate
DAY 1, 12 Hours
|
-0.156 Beats per minute
Standard Deviation 8.6466
|
1.556 Beats per minute
Standard Deviation 7.3741
|
7.286 Beats per minute
Standard Deviation 8.0517
|
|
Part 1: Change From Baseline in Pulse Rate
DAY 1, 24 Hours
|
-1.623 Beats per minute
Standard Deviation 8.9894
|
-3.044 Beats per minute
Standard Deviation 8.7852
|
4.214 Beats per minute
Standard Deviation 6.3150
|
|
Part 1: Change From Baseline in Pulse Rate
DAY 1, 48 Hours
|
-0.689 Beats per minute
Standard Deviation 8.0818
|
-0.777 Beats per minute
Standard Deviation 7.8056
|
3.429 Beats per minute
Standard Deviation 7.7752
|
|
Part 1: Change From Baseline in Pulse Rate
DAY 1, 72 Hours
|
-2.756 Beats per minute
Standard Deviation 9.7834
|
-1.844 Beats per minute
Standard Deviation 7.4755
|
2.429 Beats per minute
Standard Deviation 6.6210
|
SECONDARY outcome
Timeframe: Day -2, Day -1; 1, 2, 4, 6, 8, , 12, 24, 48, 72 hours on Day 1Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTcF 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.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY 1, 12 Hours; n=15, 14, 14
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY 1, 24 Hours; n=14, 15, 14
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY -2; n=15, 15, 14
|
10 Participants
|
9 Participants
|
9 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY -2; n=15, 15, 14
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY -1; n=15, 14, 14
|
7 Participants
|
9 Participants
|
12 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY -1; n=15, 14, 14
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY 1, 1 Hour; n=15, 15, 14
|
6 Participants
|
5 Participants
|
11 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY 1, 1 Hour; n=15, 15, 14
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY 1, 2 Hours; n=15, 15, 13
|
5 Participants
|
5 Participants
|
10 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY 1, 2 Hours; n=15, 15, 13
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY 1, 4 Hours; n=15, 13, 14
|
5 Participants
|
3 Participants
|
13 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY 1, 4 Hours; n=15, 13, 14
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY 1, 6 Hours; n=14, 14, 14
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY 1, 6 Hours; n=14, 14, 14
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY 1, 8 Hours; n=15, 15, 14
|
7 Participants
|
5 Participants
|
8 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY 1, 8 Hours; n=15, 15, 14
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY 1, 12 Hours; n=15, 14, 14
|
7 Participants
|
4 Participants
|
9 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY 1, 24 Hours; n=14, 15, 14
|
11 Participants
|
10 Participants
|
10 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY 1, 48 Hours; n=15, 15, 14
|
8 Participants
|
9 Participants
|
11 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY 1, 48 Hours; n=15, 15, 14
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
NCS: DAY 1, 72 Hours; n=15, 15, 14
|
10 Participants
|
8 Participants
|
11 Participants
|
|
Part 1: Number of Participants With Abnormal ECG Findings
CS: DAY 1, 72 Hours; n=15, 15, 14
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 6 Hours; n=14,14,14
|
6.072 Beats per minute
Standard Deviation 3.0746
|
1.643 Beats per minute
Standard Deviation 7.5799
|
5.786 Beats per minute
Standard Deviation 2.6441
|
|
Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 24 Hours; n=15,15,14
|
-2.377 Beats per minute
Standard Deviation 6.3879
|
-4.711 Beats per minute
Standard Deviation 7.0854
|
2.786 Beats per minute
Standard Deviation 4.2971
|
|
Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 8 Hours; n=15,15,14
|
2.223 Beats per minute
Standard Deviation 4.5377
|
1.489 Beats per minute
Standard Deviation 7.0631
|
2.929 Beats per minute
Standard Deviation 4.3034
|
|
Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 12 Hours; n=15,15,14
|
4.089 Beats per minute
Standard Deviation 5.0734
|
-0.178 Beats per minute
Standard Deviation 6.3675
|
6.072 Beats per minute
Standard Deviation 5.5851
|
|
Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 1 Hour; n=15,15,14
|
11.623 Beats per minute
Standard Deviation 3.5038
|
7.955 Beats per minute
Standard Deviation 7.1040
|
-0.642 Beats per minute
Standard Deviation 3.6609
|
|
Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 2 Hours; n=15,15,13
|
10.623 Beats per minute
Standard Deviation 4.8877
|
8.489 Beats per minute
Standard Deviation 6.5565
|
-1.230 Beats per minute
Standard Deviation 4.3393
|
|
Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 4 Hours; n=15,14,14
|
4.156 Beats per minute
Standard Deviation 3.2562
|
2.500 Beats per minute
Standard Deviation 7.3292
|
2.144 Beats per minute
Standard Deviation 4.9148
|
|
Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 48 Hours; n=15,15,14
|
1.023 Beats per minute
Standard Deviation 7.7608
|
-2.378 Beats per minute
Standard Deviation 6.3181
|
2.358 Beats per minute
Standard Deviation 6.3093
|
|
Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter
DAY 1, 72 Hours; n=15,15,14
|
-0.911 Beats per minute
Standard Deviation 6.1612
|
-3.045 Beats per minute
Standard Deviation 6.1332
|
2.286 Beats per minute
Standard Deviation 4.8518
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates measures PR, QRS, QT and QTcF intervals. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 24 Hours; n=15,15,14
|
-6.933 Milliseconds
Standard Deviation 10.7150
|
-9.601 Milliseconds
Standard Deviation 9.4605
|
-5.856 Milliseconds
Standard Deviation 9.6316
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 1 Hour; n= 15,15,14
|
-4.667 Milliseconds
Standard Deviation 8.7068
|
-3.067 Milliseconds
Standard Deviation 8.0354
|
-3.000 Milliseconds
Standard Deviation 4.1236
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 2 Hours; n=15,15,13
|
-6.001 Milliseconds
Standard Deviation 7.7330
|
-8.000 Milliseconds
Standard Deviation 11.0362
|
-1.846 Milliseconds
Standard Deviation 6.4305
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 4 Hours; n=15,14,14
|
-7.067 Milliseconds
Standard Deviation 10.2033
|
-5.905 Milliseconds
Standard Deviation 8.8947
|
-2.571 Milliseconds
Standard Deviation 5.2620
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 6 Hours; n=14,14,14
|
-5.286 Milliseconds
Standard Deviation 8.1501
|
-4.048 Milliseconds
Standard Deviation 7.9887
|
-7.286 Milliseconds
Standard Deviation 6.3330
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 8 Hours; n=15,15,14
|
-2.267 Milliseconds
Standard Deviation 9.6666
|
0.267 Milliseconds
Standard Deviation 9.2972
|
-7.571 Milliseconds
Standard Deviation 5.4017
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 12 Hours; n=15,15,14
|
3.599 Milliseconds
Standard Deviation 7.2967
|
3.600 Milliseconds
Standard Deviation 10.7074
|
-5.143 Milliseconds
Standard Deviation 5.5061
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 24 Hours; n=15,15,14
|
0.133 Milliseconds
Standard Deviation 6.2540
|
0.667 Milliseconds
Standard Deviation 11.6569
|
-4.000 Milliseconds
Standard Deviation 5.2761
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 48 Hours; n=15,15,14
|
0.533 Milliseconds
Standard Deviation 9.8492
|
0.267 Milliseconds
Standard Deviation 9.7100
|
-2.857 Milliseconds
Standard Deviation 4.9369
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
PR interval; DAY 1, 72 Hours; n=15,15,14
|
0.266 Milliseconds
Standard Deviation 6.7270
|
-0.800 Milliseconds
Standard Deviation 8.3925
|
0.286 Milliseconds
Standard Deviation 9.5887
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 1 Hour; n=15,15,14
|
0.177 Milliseconds
Standard Deviation 4.0981
|
-1.067 Milliseconds
Standard Deviation 2.1485
|
-1.191 Milliseconds
Standard Deviation 2.1266
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 2 Hours; n=15,15,13
|
-1.289 Milliseconds
Standard Deviation 2.7414
|
-3.601 Milliseconds
Standard Deviation 5.5916
|
-1.949 Milliseconds
Standard Deviation 3.6451
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 4 Hours; n=15,14,14
|
-0.223 Milliseconds
Standard Deviation 4.7522
|
-3.144 Milliseconds
Standard Deviation 5.5231
|
-1.334 Milliseconds
Standard Deviation 3.5564
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 6 Hours; n=14,14,14
|
1.190 Milliseconds
Standard Deviation 4.4691
|
-1.096 Milliseconds
Standard Deviation 3.4838
|
-0.048 Milliseconds
Standard Deviation 2.9515
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 8 Hours; n=15,15,14
|
-1.023 Milliseconds
Standard Deviation 5.4315
|
-1.201 Milliseconds
Standard Deviation 3.2956
|
-1.476 Milliseconds
Standard Deviation 3.0398
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 12 Hours; n=15,15,14
|
0.577 Milliseconds
Standard Deviation 5.0503
|
0.266 Milliseconds
Standard Deviation 3.0628
|
-0.905 Milliseconds
Standard Deviation 2.3614
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 24 Hours; n=15,15,14
|
-0.489 Milliseconds
Standard Deviation 3.9399
|
-0.001 Milliseconds
Standard Deviation 3.2548
|
-1.762 Milliseconds
Standard Deviation 2.7249
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 48 Hours; n=15,15,14
|
-0.489 Milliseconds
Standard Deviation 4.0107
|
-3.601 Milliseconds
Standard Deviation 5.2408
|
-2.905 Milliseconds
Standard Deviation 2.8351
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QRS interval; DAY 1, 72 Hours; n=15,15,14
|
0.311 Milliseconds
Standard Deviation 3.4718
|
-1.067 Milliseconds
Standard Deviation 4.7049
|
-1.905 Milliseconds
Standard Deviation 2.6381
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 1 Hour; n=15,15,14
|
-27.511 Milliseconds
Standard Deviation 9.5694
|
-23.333 Milliseconds
Standard Deviation 8.8511
|
-0.334 Milliseconds
Standard Deviation 6.8828
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 2 Hours; n=15,15,13
|
-30.844 Milliseconds
Standard Deviation 12.7773
|
-26.266 Milliseconds
Standard Deviation 8.5061
|
1.435 Milliseconds
Standard Deviation 9.3833
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 4 Hours; n=15,14,14
|
-17.377 Milliseconds
Standard Deviation 12.8317
|
-15.523 Milliseconds
Standard Deviation 12.6937
|
-2.191 Milliseconds
Standard Deviation 12.9124
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 6 Hours; n=14,14,14
|
-15.524 Milliseconds
Standard Deviation 10.6107
|
-10.619 Milliseconds
Standard Deviation 14.9602
|
-23.334 Milliseconds
Standard Deviation 16.4029
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 8 Hours; n=15,15,14
|
-9.511 Milliseconds
Standard Deviation 12.7754
|
-6.266 Milliseconds
Standard Deviation 16.7718
|
-12.762 Milliseconds
Standard Deviation 13.2960
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 12 Hours; n=15,15,14
|
-16.044 Milliseconds
Standard Deviation 19.7270
|
-9.466 Milliseconds
Standard Deviation 15.0727
|
-24.334 Milliseconds
Standard Deviation 22.8434
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 24 Hours; n=15,15,14
|
-2.044 Milliseconds
Standard Deviation 14.0881
|
0.801 Milliseconds
Standard Deviation 12.2568
|
-11.476 Milliseconds
Standard Deviation 12.3125
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 48 Hours; n=15,15,14
|
-3.644 Milliseconds
Standard Deviation 17.8393
|
-0.666 Milliseconds
Standard Deviation 14.5496
|
-7.476 Milliseconds
Standard Deviation 12.3459
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QT interval; DAY 1, 72 Hours; n=15,15,14
|
-0.977 Milliseconds
Standard Deviation 15.5657
|
0.134 Milliseconds
Standard Deviation 13.0685
|
-12.762 Milliseconds
Standard Deviation 15.3517
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 1 Hour; n=15,15,14
|
-4.666 Milliseconds
Standard Deviation 10.4724
|
-8.868 Milliseconds
Standard Deviation 7.0866
|
-2.285 Milliseconds
Standard Deviation 11.8494
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 2 Hours; n=15,15,13
|
-10.133 Milliseconds
Standard Deviation 10.8407
|
-11.068 Milliseconds
Standard Deviation 8.0958
|
-2.076 Milliseconds
Standard Deviation 12.2719
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 4 Hours; n=15,14,14
|
-8.466 Milliseconds
Standard Deviation 10.1552
|
-11.335 Milliseconds
Standard Deviation 10.1802
|
1.858 Milliseconds
Standard Deviation 10.9901
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 6 Hours; n=14,14,14
|
-3.714 Milliseconds
Standard Deviation 9.3976
|
-7.573 Milliseconds
Standard Deviation 12.1949
|
-10.499 Milliseconds
Standard Deviation 12.0696
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 8 Hours; n=15,15,14
|
-4.333 Milliseconds
Standard Deviation 11.3261
|
-3.268 Milliseconds
Standard Deviation 14.6848
|
-6.356 Milliseconds
Standard Deviation 11.4959
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 12 Hours; n=15,15,14
|
-7.199 Milliseconds
Standard Deviation 11.5629
|
-9.735 Milliseconds
Standard Deviation 15.8796
|
-11.214 Milliseconds
Standard Deviation 12.2055
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 48 Hours; n=15,15,14
|
-0.999 Milliseconds
Standard Deviation 12.4826
|
-5.601 Milliseconds
Standard Deviation 5.4868
|
-3.785 Milliseconds
Standard Deviation 9.7479
|
|
Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters
QTcF interval; DAY 1, 72 Hours; n=15,15,14
|
-2.466 Milliseconds
Standard Deviation 9.5081
|
-6.401 Milliseconds
Standard Deviation 10.0613
|
-7.785 Milliseconds
Standard Deviation 12.1949
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Tlag is a time delay between drug administration and first observed concentration. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Tlag Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
|
1.000 Hours
Interval 0.0 to 2.0
|
1.000 Hours
Interval 0.0 to 3.5
|
0.500 Hours
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Tmax Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
|
11.967 Hours
Interval 1.5 to 24.02
|
5.983 Hours
Interval 2.0 to 24.03
|
3.508 Hours
Interval 2.0 to 11.97
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: T1/2 Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
|
15.606 Hours
Geometric Coefficient of Variation 14.84
|
15.692 Hours
Geometric Coefficient of Variation 17.28
|
17.061 Hours
Geometric Coefficient of Variation 19.01
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Tlast Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
|
119.983 Hours
Interval 119.8 to 120.2
|
119.983 Hours
Interval 119.7 to 120.08
|
120.017 Hours
Interval 95.87 to 120.42
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: Plasma Drug Concentration at 24 Hours (C24) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
|
84.536 Nanograms per milliliter
Geometric Coefficient of Variation 41.93
|
75.643 Nanograms per milliliter
Geometric Coefficient of Variation 32.57
|
26.852 Nanograms per milliliter
Geometric Coefficient of Variation 35.39
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1Population: Pharmacokinetic Population
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
n=14 Participants
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 1: AUC(0-t) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State
|
4595.35 Hours* nanograms per milliliter
Geometric Coefficient of Variation 40.28
|
4371.47 Hours* nanograms per milliliter
Geometric Coefficient of Variation 30.03
|
1776.21 Hours* nanograms per milliliter
Geometric Coefficient of Variation 36.60
|
SECONDARY outcome
Timeframe: Pre-dose on Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11 in Part 2Population: Pharmacokinetic Population
Blood sample were collected at indicated time points to assess pre-dose concentration of GSK2838232 when administered as non-boosted once-daily doses of a tablet formulation for 11 days in Part 2. Slope and 90 percent confidence interval have been presented.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State
Pre-dose, Days 3-11
|
-0.00910 Nanograms per milliliter per study day
Interval -0.0239 to 0.00574
|
—
|
—
|
|
Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State
Pre-dose, Days 4-11
|
-0.0150 Nanograms per milliliter per study day
Interval -0.0337 to 0.00377
|
—
|
—
|
|
Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State
Pre-dose, Days 5-11
|
-0.0379 Nanograms per milliliter per study day
Interval -0.0584 to 0.0174
|
—
|
—
|
|
Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State
Pre-dose, Days 6-11
|
-0.0490 Nanograms per milliliter per study day
Interval -0.0717 to -0.0263
|
—
|
—
|
|
Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State
Pre-dose, Days 7-11
|
-0.0679 Nanograms per milliliter per study day
Interval -0.0971 to -0.0388
|
—
|
—
|
|
Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State
Pre-dose, Days 8-11
|
-0.0672 Nanograms per milliliter per study day
Interval -0.111 to -0.0233
|
—
|
—
|
|
Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State
Pre-dose, Days 9-11
|
-0.107 Nanograms per milliliter per study day
Interval -0.182 to -0.0322
|
—
|
—
|
|
Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State
Pre-dose, Days 10-11
|
-0.263 Nanograms per milliliter per study day
Interval -0.392 to -0.133
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2Population: Pharmacokinetic Population
Blood sample were collected at indicated time points to calculate accumulation ratio from AUC(0-tau) following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, AUC (0-tau) divided by Day 1, AUC (0-tau).
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Accumulation Ratio Calculated From AUC(0-tau) Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation
|
1.3340 Ratio of AUC
Standard Deviation 0.18272
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2Population: Pharmacokinetic Population
Blood sample were collected at indicated time points to calculate accumulation ratio from Cmax following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, Cmax divided by Day 1, Cmax.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Accumulation Ratio Calculated From Cmax Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation
|
1.2118 Ratio of Cmax
Standard Deviation 0.28582
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2Population: Pharmacokinetic Population
Blood sample were collected at indicated time points to calculate accumulation ratio from Ctau following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, Ctau divided by Day 1, Ctau.
Outcome measures
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=7 Participants
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fasted
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
|---|---|---|---|
|
Part 2: Accumulation Ratio Calculated From Ctau Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation
|
1.3205 Ratio of Ctau
Standard Deviation 0.32907
|
—
|
—
|
Adverse Events
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
Part 1: GSK 200 mg/Ritonavir Tablet Fasted
Part 2: Placebo
Part 2: GSK2838232 500 mg Tablet Fed
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: GSK2838232 200 mg/Ritonavir Capsule Fed
n=15 participants at risk
Participants received a single dose of GSK2838232 200 mg (as 4 x 50 mg) capsule formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK2838232 200 mg/Ritonavir Tablet Fed
n=15 participants at risk
Participants received a single dose of GSK2838232 200 mg (as 2 x 10 mg) tablet formulation along with ritonavir 100 mg tablet administered under fed conditions in treatment periods 1 and 2.
|
Part 1: GSK 200 mg/Ritonavir Tablet Fasted
n=14 participants at risk
Participants received a single dose of GSK2838232 200 mg (as 2 x 100 mg) tablet formulation under fasted conditions in treatment period 3 along with ritonavir 100 mg tablet to be taken with water in fasted condition.
|
Part 2: Placebo
n=3 participants at risk
Eligible participants received single daily doses of placebo tablet orally along with water in fed condition for 11 days.
|
Part 2: GSK2838232 500 mg Tablet Fed
n=7 participants at risk
Eligible participants received non-ritonavir boosted GSK2838232 500 mg, given as single daily doses in fed condition for 11 days.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
1/15 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.7%
1/15 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 2 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
General disorders
Chest discomfort
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
6.7%
1/15 • Number of events 2 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
General disorders
Infusion site pain
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
6.7%
1/15 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
6.7%
1/15 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
7.1%
1/14 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Number of events 3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/3 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/15 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/14 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
33.3%
1/3 • Number of events 1 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
0.00%
0/7 • Serious adverse events (SAEs) and Non-SAEs were collected up to 60 days in Part 1 of the study and up to 25 days in Part 2 of the study.
SAEs and Non-SAEs were reported for the Safety Population which comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment.
|
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