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A Study to Investigate the Pharmacokinetics (PK) of Modified Release (MR) Prototype Coated Tablet Formulations of GSK2982772

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649412
Recruitment Status : Completed
First Posted : August 28, 2018
Results First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
Quotient Sciences
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autoimmune Diseases
Interventions Drug: GSK2982772 Modified Release
Drug: GSK2982772 Immediate Release
Enrollment 33
Recruitment Details This was an open-label, 2-part (Part A & B), single dose study in healthy participants to assess modified release (MR) prototype coated tablet formulations of GSK2982772 compared to an immediate release reference tablet formulation.
Pre-assignment Details A total of 33 participants were enrolled in this study. In Part A, 16 participants were enrolled but 1 replacement participant was added (total=17). Participants from Part A did not continue to Part B. In Part B, 16 participants were enrolled.
Arm/Group Title MR 12h Fast/IR Fast/MR18h Fast/MR 18h Fed/MR 12h Fed/MR16hFast MR 480Fast/960Fast/480Fed/120Fast/480 Fed (Ent)/480 Fed(Std)
Hide Arm/Group Description Participants in Part A received a single dose of 240 milligrams (mg) GSK2982772 MR-12 hour (h) tablet (80 percent [%] release in 12 hours) in fasted (fast) state in Period 1 followed by a single dose of GSK2982772 240 mg (8x30mg) immediate release (IR) tablet in fasted state in Period 2 followed by a single dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state in Period 3. In Period 4, participants received a single dose of 240 mg GSK2982772 MR-18h tablet after a high-fat meal (fed state) followed by a single dose of MR-12h tablet after a high fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 240 mg of GSK2982772 of MR-16h tablet (80% release in 16 hours) in a fasted state. There was a washout of 7 days between each treatment period. All doses were administered orally with 240 milliliters (mL) of water. Participants in Part B received a single dose of 480 mg GSK2982772 MR-16h tablet (80% release in 16 hours) in a fasted state in Period 1 followed by a single dose 960 mg GSK2982772 MR-16h tablet in a fasted state in Period 2 followed by a single dose of 480 mg GSK2982772 MR-16h tablet after a high-fat meal (fed state) in Period 3. In Period 4, participants received a single dose of 120 mg GSK2982772 MR-16h tablet in a fasted state followed by a single dose of 480 mg GSK2982772 MR-16h enteric (Ent) coated tablet after a high-fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 480 mg GSK2982772 MR-16h tablet after a standard meal (fed state).There was a washout of 7 days between each treatment period. All doses were administered orally with 240 mL of water.
Period Title: Part A, Period 1 (4 Days)
Started 16 0
Completed 16 0
Not Completed 0 0
Period Title: Part A, Washout Period 1 (7 Days)
Started 16 0
Completed 15 0
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Period Title: Part A, Period 2 (3 Days)
Started 16 [1] 0
Completed 16 0
Not Completed 0 0
[1]
1 Replacement par. was enrolled & dosed
Period Title: Part A, Washout Period 2 (7 Days)
Started 16 0
Completed 16 0
Not Completed 0 0
Period Title: Part A, Period 3 (4 Days)
Started 16 0
Completed 16 0
Not Completed 0 0
Period Title: Part A, Washout Period 3 (7 Days)
Started 16 0
Completed 16 0
Not Completed 0 0
Period Title: Part A, Period 4 (4 Days)
Started 16 0
Completed 16 0
Not Completed 0 0
Period Title: Part A, Washout Period 4 (7 Days)
Started 16 0
Completed 14 0
Not Completed 2 0
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             1             0
Period Title: Part A, Period 5 (4 Days)
Started 12 [1] 0
Completed 12 0
Not Completed 0 0
[1]
Two participant did not start in Period 5
Period Title: Part A, Washout Period 5 (7 Days)
Started 12 0
Completed 11 0
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Part A, Period 6 (4 Days)
Started 12 [1] 0
Completed 12 0
Not Completed 0 0
[1]
1 of the participant who did not start Period 5 directly joined into Period 6
Period Title: Part B, Period 1 (4 Days)
Started 0 [1] 16 [2]
Completed 0 16
Not Completed 0 0
[1]
Participants in Part A did not enter Part B
[2]
16 new participants enrolled in Part B
Period Title: Part B, Washout Period 1 (7 Days)
Started 0 16
Completed 0 15
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Part B, Period 2 (4 Days)
Started 0 15
Completed 0 15
Not Completed 0 0
Period Title: Part B, Washout Period 2 (7 Days)
Started 0 15
Completed 0 15
Not Completed 0 0
Period Title: Part B, Period 3 (4 Days)
Started 0 15
Completed 0 15
Not Completed 0 0
Period Title: Part B, Washout Period 3 (7 Days)
Started 0 15
Completed 0 15
Not Completed 0 0
Period Title: Part B, Period 4 (4 Days)
Started 0 15
Completed 0 15
Not Completed 0 0
Period Title: Part B, Washout Period 4 (7 Days)
Started 0 15
Completed 0 15
Not Completed 0 0
Period Title: Part B, Period 5 (4 Days)
Started 0 14 [1]
Completed 0 14
Not Completed 0 0
[1]
One participant did not start in Period 5
Period Title: Part B, Washout Period 5 (7 Days)
Started 0 14
Completed 0 13
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Part B, Period 6 (4days)
Started 0 14 [1]
Completed 0 14
Not Completed 0 0
[1]
Participant who did not start Period 5 directly joined into Period 6
Arm/Group Title MR 12h Fast/IR Fast/MR18h Fast/MR 18h Fed/MR 12h Fed/MR16hFast MR 480Fast/960Fast/480Fed/120Fast/480 Fed (Ent)/480 Fed(Std) Total
Hide Arm/Group Description Participants in Part A received a single dose of 240 milligrams (mg) GSK2982772 MR-12 hour (h) tablet (80 percent [%] release in 12 hours) in fasted (fast) state in Period 1 followed by a single dose of GSK2982772 240 mg (8x30mg) immediate release (IR) tablet in fasted state in Period 2 followed by a single dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state in Period 3. In Period 4, participants received a single dose of 240 mg GSK2982772 MR-18h tablet after a high-fat meal (fed state) followed by a single dose of MR-12h tablet after a high fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 240 mg of GSK2982772 of MR-16h tablet (80% release in 16 hours) in a fasted state. There was a washout of 7 days between each treatment period. All doses were administered orally with 240 milliliters (mL) of water. Participants in Part B received a single dose of 480 mg GSK2982772 MR-16h tablet (80% release in 16 hours) in a fasted state in Period 1 followed by a single dose 960 mg GSK2982772 MR-16h tablet in a fasted state in Period 2 followed by a single dose of 480 mg GSK2982772 MR-16h tablet after a high-fat meal (fed state) in Period 3. In Period 4, participants received a single dose of 120 mg GSK2982772 MR-16h tablet in a fasted state followed by a single dose of 480 mg GSK2982772 MR-16h enteric (Ent) coated tablet after a high-fat meal (fed state) in Period 5. In Period 6, participants received a single dose of 480 mg GSK2982772 MR-16h tablet after a standard meal (fed state).There was a washout of 7 days between each treatment period. All doses were administered orally with 240 mL of water. Total of all reporting groups
Overall Number of Baseline Participants 17 16 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 16 participants 33 participants
43.5  (12.17) 54.0  (6.30) 48.6  (11.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Female
7
  41.2%
6
  37.5%
13
  39.4%
Male
10
  58.8%
10
  62.5%
20
  60.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
ARABIC/NORTH AFRICAN HERITAGE
1
   5.9%
0
   0.0%
1
   3.0%
WHITE/CAUCASIAN/EUROPEAN HERITAGE
16
  94.1%
13
  81.3%
29
  87.9%
AFRICAN AMERICAN/AFRICAN HERITAGE
0
   0.0%
1
   6.3%
1
   3.0%
CENTRAL/SOUTH ASIAN HERITAGE
0
   0.0%
1
   6.3%
1
   3.0%
MULTIPLE
0
   0.0%
1
   6.3%
1
   3.0%
1.Primary Outcome
Title Part A: Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 240 mg in IR Formulation
Hide Description Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. PK parameters were analyzed using standard non-compartmental analysis. Participants in the 'Safety Population (all participants who received at least one dose of study treatment)' for whom a PK sample was obtained and analyzed were part of PK Population.
Time Frame Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
14.355
(31.1%)
2.Primary Outcome
Title Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation
Hide Description Blood samples were collected from participants at indicated time points for PK analysis. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at specified time points were analyzed.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 12 13 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
7.757
(19.1%)
8.346
(27.7%)
7.080
(46.8%)
3.Primary Outcome
Title Part A: AUC(0-inf) of GSK2982772 240 mg in MR Coated Tablet Formulation After High-fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points for PK analysis. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at specified time points were analyzed.
Arm/Group Title Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat)
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Overall Number of Participants Analyzed 7 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
9.372
(21.8%)
8.220
(37.2%)
4.Primary Outcome
Title Part A: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 240 mg for IR Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
14.269
(31.2%)
5.Primary Outcome
Title Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
8.175
(23.9%)
7.828
(28.5%)
7.365
(36.4%)
6.Primary Outcome
Title Part A: AUC(0-t) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat)
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Overall Number of Participants Analyzed 12 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
9.359
(23.1%)
8.384
(32.7%)
7.Primary Outcome
Title Part A: Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 240 mg for IR Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24). PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
14.268
(31.2%)
8.Primary Outcome
Title Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24). PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
6.670
(24.9%)
5.784
(31.8%)
5.466
(33.1%)
9.Primary Outcome
Title Part A: AUC(0-24) of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24). PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat)
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Overall Number of Participants Analyzed 12 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
7.136
(33.5%)
5.821
(32.1%)
10.Primary Outcome
Title Part A: Maximum Observed Concentration (Cmax) of GSK2982772 240 mg for IR Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
3.177
(40.1%)
11.Primary Outcome
Title Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
0.682
(39.4%)
0.527
(24.4%)
0.466
(27.5%)
12.Primary Outcome
Title Part A: Cmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat)
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Overall Number of Participants Analyzed 12 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
0.824
(47.5%)
0.678
(47.0%)
13.Primary Outcome
Title Part A: Concentration at 24 Hours Post-dose (C24h) of GSK2982772 240 mg for IR Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
0.015
(60.8%)
14.Primary Outcome
Title Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
0.196
(64.8%)
0.211
(63.1%)
0.165
(98.3%)
15.Primary Outcome
Title Part A: C24h of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat)
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Overall Number of Participants Analyzed 12 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
0.213
(70.4%)
0.265
(85.5%)
16.Primary Outcome
Title Part A: Time to Cmax (Tmax) of GSK2982772 240 mg for IR Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Median (Full Range)
Unit of Measure: Hours
2.000
(1.00 to 5.00)
17.Primary Outcome
Title Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12
Median (Full Range)
Unit of Measure: Hours
5.000
(4.00 to 12.03)
10.000
(4.00 to 24.20)
6.000
(4.00 to 16.00)
18.Primary Outcome
Title Part A: Tmax of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat)
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Overall Number of Participants Analyzed 12 16
Median (Full Range)
Unit of Measure: Hours
8.000
(2.00 to 22.00)
11.000
(8.00 to 22.32)
19.Primary Outcome
Title Part A: Terminal Half-life (t1/2) of GSK2982772 240 mg for IR Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Hours
3.288  (0.5010)
20.Primary Outcome
Title Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation
Hide Description Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12
Mean (Standard Deviation)
Unit of Measure: Hours
6.329  (2.1447) 6.953  (2.4983) 7.532  (2.2685)
21.Primary Outcome
Title Part A: t1/2 of GSK2982772 240 mg for MR Coated Tablet Formulation After High-fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat)
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Overall Number of Participants Analyzed 12 16
Mean (Standard Deviation)
Unit of Measure: Hours
7.763  (1.4693) 6.589  (1.0499)
22.Primary Outcome
Title Part B: AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for AUC(0-inf). PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at specified time points were analyzed.
Arm/Group Title Part B: MR-16h 480mg Fed (High-Fat) Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated)
Hide Arm/Group Description:
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast (fed state)
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) enteric coated tablet after a high fat breakfast (fed state)
Overall Number of Participants Analyzed 11 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
20.121
(46.2%)
20.178
(62.8%)
23.Primary Outcome
Title Part B: AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for AUC(0-t). PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part B: MR-16h 480mg Fed (High-Fat) Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated)
Hide Arm/Group Description:
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast (fed state)
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) enteric coated tablet after a high fat breakfast (fed state)
Overall Number of Participants Analyzed 15 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
19.865
(39.7%)
17.861
(47.1%)
24.Primary Outcome
Title Part B: Cmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for Cmax. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part B: MR-16h 480mg Fed (High-Fat) Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated)
Hide Arm/Group Description:
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast (fed state)
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) enteric coated tablet after a high fat breakfast (fed state)
Overall Number of Participants Analyzed 15 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hours*microgram per milliliter
1.896
(63.3%)
1.791
(75.0%)
25.Primary Outcome
Title Part B: C24h of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for C24h. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part B: MR-16h 480mg Fed (High-Fat) Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated)
Hide Arm/Group Description:
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast (fed state)
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) enteric coated tablet after a high fat breakfast (fed state)
Overall Number of Participants Analyzed 15 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
0.622
(132.9%)
1.176
(80.6%)
26.Primary Outcome
Title Part B: Tmax of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for Tmax. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part B: MR-16h 480mg Fed (High-Fat) Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated)
Hide Arm/Group Description:
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast (fed state)
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) enteric coated tablet after a high fat breakfast (fed state)
Overall Number of Participants Analyzed 15 14
Median (Full Range)
Unit of Measure: Hours
12.000
(6.00 to 28.00)
22.008
(10.00 to 24.05)
27.Primary Outcome
Title Part B: t1/2 of GSK2982772 for MR Coated Tablet Formulation After a High Fat Breakfast
Hide Description Blood samples were collected from participants at indicated time points and analyzed for t1/2. PK parameters were analyzed using standard non-compartmental analysis.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at specified time point were analyzed.
Arm/Group Title Part B: MR-16h 480mg Fed (High-Fat) Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated)
Hide Arm/Group Description:
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast (fed state)
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) enteric coated tablet after a high fat breakfast (fed state)
Overall Number of Participants Analyzed 11 8
Mean (Standard Deviation)
Unit of Measure: Hours
4.961  (1.0921) 4.873  (1.9915)
28.Primary Outcome
Title Part A: Relative Bioavailability in Fed Versus Fasted Conditions (FrelFE) Based on AUC(0-inf) of GSK2982772 for MR Coated Tablet Formulation
Hide Description Blood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR Fed/ Geometric mean of AUC(0-inf) of MR Fasted multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at specified time points were analyzed.
Arm/Group Title Part A: MR-18h 240mg Fed and MR-18h 240mg Fasted Part A: MR-12h 240mg Fed and MR-12h 240mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fed (high-fat) state and received MR-18h (80% release in 18 hours) tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h (80% release in 12 hours) tablet in fed (high-fat) state and received MR-12h (80% release in 12 hours) tablet in fasted state
Overall Number of Participants Analyzed 13 12
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
102.66
(88.84 to 118.63)
113.66
(95.53 to 135.24)
29.Primary Outcome
Title Part A: FrelFE Based on AUC(0-t) of GSK2982772 for MR Coated Tablet Formulation
Hide Description Blood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772. Frel for AUC(0-t) was calculated as Geometric mean of AUC(0-t) of MR Fed/Geometric mean of AUC(0-t) of MR Fasted multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-18h 240mg Fed and MR-18h 240mg Fasted Part A: MR-12h 240mg Fed and MR-12h 240mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fed (high-fat) state and received MR-18h (80% release in 18 hours) tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h (80% release in 12 hours) tablet in fed (high-fat) state and received MR-12h (80% release in 12 hours) tablet in fasted state
Overall Number of Participants Analyzed 16 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
107.11
(95.72 to 119.85)
107.81
(95.16 to 122.14)
30.Primary Outcome
Title Part A: FrelFE Based on Cmax of GSK2982772 for MR Coated Tablet Formulation
Hide Description Blood samples were collected at indicated time points for analysis of FrelFE based on Cmax of GSK2982772. Frel for Cmax was calculated as Geometric mean of Cmax of MR Fed/Geometric mean of Cmax of MR Fasted multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-18h 240mg Fed and MR-18h 240mg Fasted Part A: MR-12h 240mg Fed and MR-12h 240mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fed (high-fat) state and received MR-18h (80% release in 18 hours) tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h (80% release in 12 hours) tablet in fed (high-fat) state and received MR-12h (80% release in 12 hours) tablet in fasted state
Overall Number of Participants Analyzed 16 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
128.79
(108.64 to 152.67)
112.15
(92.90 to 135.38)
31.Primary Outcome
Title Part B: FrelFE of GSK2982772 Based on AUC(0-inf) for MR Coated Tablet Formulation in Fed vs Fasted State
Hide Description Blood samples were collected at indicated time points for analysis of FrelFE based on AUC(0-inf) of GSK2982772. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR Fed/ Geometric mean of AUC(0-inf) of MR Fasted multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at specified time frame were analyzed.
Arm/Group Title Part B: MR-16h 480mg Fed (High-fat) and MR-16h 480mg Fasted Part B: MR-16h 480mg Fed (Standard) and MR-16h 480mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast in fed state and received a single oral dose of 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after a standard breakfast in fed state and received a single oral dose of 480mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Overall Number of Participants Analyzed 11 12
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
141.75
(113.47 to 177.07)
97.13
(78.47 to 120.22)
32.Primary Outcome
Title Part B: FrelFE of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fed vs Fasted State
Hide Description Blood samples were collected at indicated time points for analysis of FrelFE based on AUC (0-t) of GSK2982772. FrelFE for AUC (0-t) was calculated as Geometric mean of AUC (0-t) of MR Fed/ Geometric mean of AUC (0-t) of MR Fasted multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part B: MR-16h 480mg Fed (High-fat) and MR-16h 480mg Fasted Part B: MR-16h 480mg Fed (Standard) and MR-16h 480mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast in fed state and received a single oral dose of 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after a standard breakfast in fed state and received a single oral dose of 480mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Overall Number of Participants Analyzed 16 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
129.63
(109.23 to 153.83)
89.77
(75.37 to 106.92)
33.Primary Outcome
Title Part B: FrelFE of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fed vs Fasted State
Hide Description Blood samples were collected at indicated time points for analysis of FrelFE based on Cmax of GSK2982772. FrelFE for Cmax was calculated as Geometric mean of Cmax of MR Fed/ Geometric mean of Cmax of MR Fasted multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part B: MR-16h 480mg Fed (High-fat) vs MR-16h 480mg Fasted Part B: MR-16h 480mg Fed (Standard) and MR-16h 480mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast in fed state and received a single oral dose of 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after a standard breakfast in fed state and received a single oral dose of 480mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Overall Number of Participants Analyzed 16 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
173.19
(138.68 to 216.28)
102.39
(81.61 to 128.47)
34.Primary Outcome
Title Part B: Frel of GSK2982772 Based on AUC (0-inf) for MR Coated Tablet Formulation in Fasted State
Hide Description Blood samples were collected at indicated time points for analysis of Frel (dose) based on AUC (0-inf) of GSK2982772. Frel (dose) for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MR formulation (test dose) Fasted/ Geometric mean of AUC (0-inf) of MR Fasted formulation (reference dose) multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at specified time points were analyzed.
Arm/Group Title Part B: MR-16h 960mg Fasted and MR-16h 480mg Fasted Part B: MR-16h 960mg Fasted vs MR-16h 120mg Fasted Part B: MR-16h 480mg Fasted vs MR-16h 120mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Overall Number of Participants Analyzed 10 14 14
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
214.21
(171.24 to 267.95)
530.86
(431.89 to 652.49)
247.82
(201.70 to 304.49)
35.Primary Outcome
Title Part B: Frel of GSK2982772 Based on AUC (0-t) for MR Coated Tablet Formulation in Fasted State
Hide Description Blood samples were collected at indicated time points for analysis of Frel (dose) based on AUC(0-t) of GSK2982772. Frel (dose) for AUC(0-t) was calculated as Geometric mean of AUC(0-t) of MR formulation (test dose) Fasted/ Geometric mean of AUC(0-t) of MR Fasted formulation (reference dose) multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part B: MR-16h 960mg Fasted vs MR-16h 480mg Fasted Part B: MR-16h 960mg Fasted vs MR-16h 120mg Fasted Part B: MR-16h 480mg Fasted vs MR-16h 120mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Overall Number of Participants Analyzed 16 15 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
192.81
(162.47 to 228.80)
539.66
(454.37 to 640.96)
279.90
(235.86 to 332.16)
36.Primary Outcome
Title Part B: Frel of GSK2982772 Based on AUC (0-24) for MR Coated Tablet Formulation in Fasted State
Hide Description Blood samples were collected at indicated time points for analysis of Frel (dose) based on AUC(0-24) of GSK2982772. Frel (dose) for AUC(0-24) was calculated as Geometric mean of AUC(0-24) of MR formulation (test dose) Fasted/Geometric mean of AUC(0-24) of MR Fasted formulation (reference dose) multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part B: MR-16h 960mg Fasted vs MR-16h 480mg Fasted Part B: MR-16h 960mg Fasted vs MR-16h 120mg Fasted Part B: MR-16h 480mg Fasted vs MR-16h 120mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Overall Number of Participants Analyzed 16 15 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
175.58
(143.34 to 215.08)
392.65
(320.16 to 481.54)
223.63
(182.56 to 273.93)
37.Primary Outcome
Title Part B: Frel of GSK2982772 Based on Cmax for MR Coated Tablet Formulation in Fasted State
Hide Description Blood samples were collected at indicated time points for analysis of Frel dose. Frel for Cmax was calculated as Geometric mean of Cmax of MR formulation (test) Fasted/ Geometric mean of Cmax of MR Fasted Formulation (reference dose) multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part B: MR-16h 960mg Fasted vs MR-16h 480mg Fasted Part B: MR-16h 960mg Fasted vs MR-16h 120mg Fasted Part B: MR-16h 480mg Fasted vs MR-16h 120mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
Overall Number of Participants Analyzed 16 15 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
160.00
(128.12 to 199.81)
338.70
(270.88 to 423.89)
211.68
(169.51 to 264.35)
38.Primary Outcome
Title Part A: Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 240 mg
Hide Description Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC(0-inf) of GSK2982772 in fasted state. Frel for AUC(0-inf) was calculated as Geometric mean of AUC(0-inf) of MR formulation (test) Fasted/ Geometric mean of AUC(0-inf) of Fasted of IR Formulation (reference) multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240mg Fasted and IR 240mg Fasted Part A: MR-16h 240mg Fasted and IR 240mg Fasted Part A: MR-18h 240mg Fasted and IR 240mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h (80% release in 12 hours) tablet in fasted state and received a single oral dose of 240 mg GSK2982772 IR tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received a single oral dsoe of 240 mg GSK2982772 IR tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state and received a single oral dose of 240 mg GSK2982772 IR tablet in fasted state
Overall Number of Participants Analyzed 16 16 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
54.68
(47.64 to 62.76)
48.32
(40.96 to 57.01)
57.69
(50.58 to 65.80)
39.Primary Outcome
Title Part A: Frelformulation Based on AUC (0-t) of GSK2982772 for MR Coated Tablet Formulation (240 mg)
Hide Description Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 in fasted state. Frel for AUC (0-t) was calculated as Geometric mean of AUC(0-t) of MR Fasted formulation (test) / Geometric mean of AUC(0-t) of Fasted of IR Formulation (reference) multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240mg Fasted and IR 240mg Fasted Part A: MR-16h 240mg Fasted and IR 240mg Fasted Part A: MR-18h 240mg Fasted and IR 240mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h (80% release in 12 hours) tablet in fasted state and received a single oral dose of 240 mg GSK2982772 IR tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received a single oral dsoe of 240 mg GSK2982772 IR tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state and received a single oral dose of 240 mg GSK2982772 IR tablet in fasted state
Overall Number of Participants Analyzed 16 16 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
57.72
(51.51 to 64.69)
49.61
(43.86 to 56.11)
54.86
(49.03 to 61.39)
40.Primary Outcome
Title Part A: Frelformulation Based on AUC(0-24) of GSK2982772 for MR Coated Tablet Formulation (240 mg)
Hide Description Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 in fasted state. Frel for AUC(0-24) was calculated as Geometric mean of AUC(0-24) of MR Fasted formulation (test) / Geometric mean of AUC(0-24) of Fasted of IR Formulation (reference) multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240mg Fasted and IR 240mg Fasted Part A: MR-16h 240mg Fasted and IR 240mg Fasted Part A: MR-18h 240mg Fasted and IR 240mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h (80% release in 12 hours) tablet in fasted state and received a single oral dose of 240 mg GSK2982772 IR tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received a single oral dsoe of 240 mg GSK2982772 IR tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state and received a single oral dose of 240 mg GSK2982772 IR tablet in fasted state
Overall Number of Participants Analyzed 16 16 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
47.77
(41.92 to 54.43)
36.85
(31.99 to 42.45)
40.54
(35.63 to 46.13)
41.Primary Outcome
Title Part A: Frelformulation Based on Cmax of GSK2982772 for MR Coated Tablet Formulation (240 mg)
Hide Description Blood samples were collected at indicated time points for analysis of Frelformulation based on Cmax of GSK2982772 in fasted state. Frel for Cmax was calculated as Geometric mean of Cmax of MR Fasted formulation (test) / Geometric mean of Cmax of Fasted Formulation of IR formulation (reference) multiplied by 100.
Time Frame Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36 and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population.
Arm/Group Title Part A: MR-12h 240mg Fasted and IR 240mg Fasted Part A: MR-16h 240mg Fasted and IR 240mg Fasted Part A: MR-18h 240mg Fasted and IR 240mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h (80% release in 12 hours) tablet in fasted state and received a single oral dose of 240 mg GSK2982772 IR tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state and received a single oral dsoe of 240 mg GSK2982772 IR tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h (80% release in 18 hours) tablet in fasted state and received a single oral dose of 240 mg GSK2982772 IR tablet in fasted state
Overall Number of Participants Analyzed 16 16 16
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage bioavailability
22.29
(18.77 to 26.47)
14.16
(11.75 to 17.06)
16.58
(13.99 to 19.66)
42.Secondary Outcome
Title Part A: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events that may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before.
Time Frame Up to Day 67
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Hide Analysis Population Description
Safety Population consisted of all participants who receive at least 1 dose of study treatment.
Arm/Group Title Part A: IR 240 mg Fasted Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat) Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 16 12 16 12
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
2
  12.5%
5
  31.3%
3
  18.8%
3
  25.0%
3
  18.8%
4
  33.3%
Any SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
43.Secondary Outcome
Title Part A: Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria
Hide Description Clinical chemistry parameters with PCI values:albumin (low: <30 millimoles per liter[mmol/L]), Alanine transaminase (ALT) (high: >=2xupper limit of normal [ULN]), Aspartate Aminotransferase(AST) (high: >=2xULN), Alkaline phosphatase(ALP) (high:>=2xULN), calcium(low: <2 mmol/L, high: >2.75 mmol/L),creatinine (high: >44.2 mmol/L),glucose (low: <3 mmol/L,high: >9 mmol/L), potassium (low: <3 mmol/L,high: >5.5 mmol/L),sodium (low: <130 mmol/L,high: >150 mmol/L),total bilirubin(high :>= 1.5xULN). Participants are 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 value category was unchanged (e.g., High to High),or whose value became normal, are recorded in the "To Normal or No Change" category. Participants are counted twice if the participants has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Data for worst-case post-Baseline has been reported.
Time Frame Up to Day 67
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Part A: IR 240 mg Fasted Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat) Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 16 12 16 12
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
ALT, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
AST, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
ALP, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Albumin, To low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Albumin, To Normal or no Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
Calcium, To low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  12.5%
0
   0.0%
Calcium, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
14
  87.5%
12
 100.0%
Calcium, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
Creatinine, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose, To low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
Glucose, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium, To low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
Potassium, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium, To low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
Sodium, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
Total Bilirubin, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
44.Secondary Outcome
Title Part A: Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria
Hide Description Hematology parameters with PCI ranges: hematocrit (high: >0.54 percentage of red blood cells), hemoglobin (high: >180 grams per liter [g/L]), lymphocytes (low: <0.8*giga cells per liter [10^9/L]), total neutrophil count (low: <1.5*10^9/L), platelet count (low: <100*10^9/L and high: >550*10^9/L), and while blood cell (WBC) count (low: <3*10^9/L and high: >20*10^9/L). Participants are 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 value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Data for worst-case post-Baseline has been reported.
Time Frame Up to Day 67
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Part A: IR 240 mg Fasted Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat) Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 16 12 16 12
Measure Type: Count of Participants
Unit of Measure: Participants
Hemotocrit, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
Hematocrit, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
Hemoglobin, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
Platelet count, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count, To Normal or No change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
Platelet count, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total neutrophils, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Neutrophils, To Normal or No Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
WBC count, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC count, To Normal or no Change
16
 100.0%
16
 100.0%
16
 100.0%
12
 100.0%
16
 100.0%
12
 100.0%
WBC count, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
45.Secondary Outcome
Title Part A: Number of Participants With Abnormal Urinalysis Dipstick Results
Hide Description Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination was performed abnormal data for red blood cells (RBC): 1-9 High potential field (HPF) and WBC: 1-9/ HPF; WBC: 10-50/HPF has been presented.
Time Frame Day 2 (post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Part A: IR 240 mg Fasted Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat) Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 16 12 16 12
Measure Type: Count of Participants
Unit of Measure: Participants
RBC 1-9/ HPF
0
   0.0%
2
  12.5%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
WBC 1-9/HPF
1
   6.3%
1
   6.3%
1
   6.3%
4
  33.3%
1
   6.3%
3
  25.0%
WBC 10-50/HPF
2
  12.5%
0
   0.0%
1
   6.3%
0
   0.0%
0
   0.0%
0
   0.0%
46.Secondary Outcome
Title Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in IR Formulation
Hide Description SBP and DBP were measured in a semi-supine position after 5 minutes of rest of the participant. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
SBP, Day 1, 2 hours -3.9  (6.29)
SBP, Day 1, 12 hours -3.3  (6.39)
SBP, Day 2, 24 hours -6.6  (7.26)
DBP, Day1, 2 hours -1.1  (3.00)
DBP, Day 1, 12 hours -5.1  (3.51)
DBP, Day 2, 24 hours -1.4  (4.63)
47.Secondary Outcome
Title Part A: Change From Baseline in SBP and DBP in MR Formulation
Hide Description SBP and DBP were measured in a semi-supine position after 5 minutes of rest of the participant. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat) Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12 16 12
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury
SBP, Day1, 2 hours -2.7  (5.76) -7.9  (6.82) -7.3  (8.57) -4.6  (8.38) -3.4  (9.18)
SBP, Day1, 12 hours -3.0  (8.07) -6.9  (8.32) -2.4  (10.07) -0.09  (13.02) -1.3  (10.54)
SBP, Day 2, 24 hours -3.9  (7.55) -10.3  (8.69) -2.8  (8.87) -6.8  (5.72) -2.3  (7.01)
SBP, Day3, 48 hours, -2.0  (9.29) -5.3  (7.15) -1.7  (8.87) -4.2  (7.74) 2.8  (7.88)
DBP, Day1, 2 hours -4.5  (5.67) -5.3  (5.70) -6.1  (3.53) -6.9  (5.11) -2.3  (8.64)
DBP, Day1, 12 hours -7.6  (7.46) -8.3  (5.35) -5.7  (5.14) -5.9  (6.35) -5.3  (7.12)
DBP, Day2, 24 hours -2.4  (6.30) -10.0  (4.15) -6.6  (5.76) -4.5  (4.93) -0.4  (6.82)
DBP, Day3, 48 hours -3.7  (6.26) -3.7  (4.71) -2.1  (7.33) -2.4  (5.20) -1.1  (7.74)
48.Secondary Outcome
Title Part A: Change From Baseline in Heart Rate in IR Formulation
Hide Description Heart rate was measured in a semi-supine position after 5 minutes of rest of participant. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours
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Safety Population.
Arm/Group Title Part A: IR 240 mg Fasted
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Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 1, 2 hours -2.6  (8.37)
Day 1, 12 hours 6.3  (11.51)
Day 2, 24 hours -2.1  (7.73)
49.Secondary Outcome
Title Part A: Change From Baseline in Heart Rate in MR Formulation
Hide Description Heart rate was measured in a semi-supine position after 5 minutes of rest of participant. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hours
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Safety Population.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat) Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12 16 12
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Day 1, 2 hours -1.3  (7.22) -6.1  (7.78) 5.8  (6.87) 3.1  (7.33) -1.3  (5.87)
Day 1, 12 hours 5.4  (9.62) 6.1  (9.79) 9.8  (7.72) 3.4  (10.19) 8.8  (8.41)
Day 2, 24 hours 0.7  (7.36) -4.7  (8.72) 2.4  (8.56) 1.6  (9.21) -2.4  (4.12)
Day 3, 48 hours 8.6  (11.39) 0.4  (8.58) 3.8  (5.67) 4.7  (9.71) 7.3  (7.19)
50.Secondary Outcome
Title Part A: Change From Baseline in Respiration Rate in IR Formulation
Hide Description Respiratory rate was measured in a semi-supine position after 5 minutes of rest of the participant. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours
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Safety Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
Day 1, 2 hours -0.4  (3.08)
Day 1, 12 hours -0.2  (2.10)
Day 2, 24 hours -0.8  (3.53)
51.Secondary Outcome
Title Part A: Change From Baseline in Respiration Rate in MR Formulation
Hide Description Respiratory rate was measured in a semi-supine position after 5 minutes of rest of the participant. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hours
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Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat) Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12 16 12
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
Day 1, 2 hours; n=16, 16, 12, 16, 12 Number Analyzed 16 participants 16 participants 12 participants 16 participants 12 participants
0.9  (2.89) 2.5  (2.58) 2.8  (2.29) 2.0  (2.13) 0.0  (3.25)
Day 1, 12 hours; n=15, 16, 12, 16, 12 Number Analyzed 15 participants 16 participants 12 participants 16 participants 12 participants
1.1  (1.68) 0.8  (1.94) 2.2  (2.25) 0.9  (2.14) 2.1  (3.34)
Day 2, 24 hours; n=16, 16, 12, 16, 12 Number Analyzed 16 participants 16 participants 12 participants 16 participants 12 participants
1.4  (1.93) 0.9  (2.58) 1.9  (2.43) 2.2  (1.64) 0.9  (2.68)
Day 3, 48 hours; n=16, 16, 12, 16, 12 Number Analyzed 16 participants 16 participants 12 participants 16 participants 12 participants
2.3  (3.00) 0.4  (1.79) 4.0  (2.37) 0.7  (1.99) -0.4  (2.64)
52.Secondary Outcome
Title Part A: Change From Baseline in Body Temperature in IR Formulation
Hide Description Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours
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Safety Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Degrees Celsius
Day 1, 2 hours 0.04  (0.159)
Day 1, 12 hours 0.13  (0.241)
Day 2, 24 hours 0.10  (0.183)
53.Secondary Outcome
Title Part A: Change From Baseline in Body Temperature in MR Formulation
Hide Description Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time Frame Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24 hours, Day 3: 48 hours
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Hide Analysis Population Description
Safety Population.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat) Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12 16 12
Mean (Standard Deviation)
Unit of Measure: Degrees Celsius
Day 1, 2 hours -0.04  (0.216) 0.14  (0.190) -0.03  (0.107) -0.06  (0.141) -0.04  (0.211)
Day 1, 12 hours 0.12  (0.180) 0.15  (0.266) 0.11  (0.162) -0.04  (0.150) 0.24  (0.188)
Day 2, 24 hours -0.03  (0.188) 0.12  (0.148) 0.06  (0.151) 0.05  (0.175) 0.08  (0.175)
Day 3, 48 hours -0.05  (0.163) 0.01  (0.247) 0.04  (0.156) 0.01  (0.178) 0.07  (0.222)
54.Secondary Outcome
Title Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in IR Formulation
Hide Description Single 12-lead ECGs were obtained using an automated ECG machine that calculated PR, QRS, QT and Corrected QT (QTc) intervals. ECG measurements were performed in a semi-supine or supine position. Number of participants with abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst-case post-Baseline has been reported.
Time Frame Up to Day 67
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Safety Population.
Arm/Group Title Part A: IR 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal-Not Clinically Significant
8
  50.0%
Abnormal - Clinically Significant
0
   0.0%
55.Secondary Outcome
Title Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in MR Formulation
Hide Description Single 12-lead ECGs were obtained using an automated ECG machine that calculated PR, QRS, QT and Corrected QT (QTc) intervals. ECG measurements were performed in a semi-supine or supine position. Number of participants with abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst-case post-Baseline has been reported.
Time Frame Up to Day 67
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Safety Population.
Arm/Group Title Part A: MR-12h 240 mg Fasted Part A: MR-18h 240 mg Fasted Part A: MR-12h 240 mg Fed (High-Fat) Part A: MR-18h 240 mg Fed (High-fat) Part A: MR-16h 240 mg Fasted
Hide Arm/Group Description:
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state
Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state
Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state
Overall Number of Participants Analyzed 16 16 12 16 12
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal-Not Clinically Significant
8
  50.0%
10
  62.5%
5
  41.7%
9
  56.3%
7
  58.3%
Abnormal - Clinically Significant
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Non-serious AEs and SAEs were collected up to Day 67 for Part A and up to Day 68 for Part B
Adverse Event Reporting Description Non-serious AEs and SAEs were collected in Safety population.
 
Arm/Group Title Part A: IR 240 mg Fasted Part A: MR-12h 240 mg Fasted Part A: MR-18h 240mg Fasted Part A: MR-12h 240mg Fed (High-Fat) Part A: MR-18h 240mg Fed (High-Fat) Part A: MR-16h 240mg Fasted Part B: MR-16h 480mg Fasted Part B: MR-16h 480 mg Fed (Std) Part B: MR-16h 480mg Fed (High-fat) Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated) Part B: MR-16h 960mg Fasted Part B: MR-16h 120mg Fasted
Hide Arm/Group Description Participants received a single oral dose of 240 mg (8x30mg) GSK2982772 IR tablet in a fasted state Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet in fasted state Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet in fasted state Participants received a single oral dose of 240 mg GSK2982772 MR-12h tablet after a high fat meal in fed state Participants received a single oral dose of 240 mg GSK2982772 MR-18h tablet after high fat meal in fed state Participants received a single oral dose of 240 mg GSK2982772 MR-16h tablet in fasted state Participants received a single oral dose of 480 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after a standard breakfast (fed state) Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) tablet after high fat breakfast (fed state) Participants received a single oral dose of 480 mg GSK2982772 MR-16h (80% release in 16 hours) enteric coated tablet after a high fat breakfast (fed state) Participants received a single oral dose of 960 mg GSK2982772 MR-16h (80% release in 16 hours) tablet in fasted state Participants received 120 mg GSK2982772 MR-16 h (80% release in 16 hours) tablet in fasted state
All-Cause Mortality
Part A: IR 240 mg Fasted Part A: MR-12h 240 mg Fasted Part A: MR-18h 240mg Fasted Part A: MR-12h 240mg Fed (High-Fat) Part A: MR-18h 240mg Fed (High-Fat) Part A: MR-16h 240mg Fasted Part B: MR-16h 480mg Fasted Part B: MR-16h 480 mg Fed (Std) Part B: MR-16h 480mg Fed (High-fat) Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated) Part B: MR-16h 960mg Fasted Part B: MR-16h 120mg Fasted
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/16 (0.00%)      0/16 (0.00%)      0/12 (0.00%)      0/16 (0.00%)      0/12 (0.00%)      0/16 (0.00%)      0/14 (0.00%)      0/15 (0.00%)      0/14 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
Part A: IR 240 mg Fasted Part A: MR-12h 240 mg Fasted Part A: MR-18h 240mg Fasted Part A: MR-12h 240mg Fed (High-Fat) Part A: MR-18h 240mg Fed (High-Fat) Part A: MR-16h 240mg Fasted Part B: MR-16h 480mg Fasted Part B: MR-16h 480 mg Fed (Std) Part B: MR-16h 480mg Fed (High-fat) Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated) Part B: MR-16h 960mg Fasted Part B: MR-16h 120mg Fasted
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)      0/16 (0.00%)      0/12 (0.00%)      0/16 (0.00%)      0/12 (0.00%)      0/16 (0.00%)      0/14 (0.00%)      0/15 (0.00%)      0/14 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part A: IR 240 mg Fasted Part A: MR-12h 240 mg Fasted Part A: MR-18h 240mg Fasted Part A: MR-12h 240mg Fed (High-Fat) Part A: MR-18h 240mg Fed (High-Fat) Part A: MR-16h 240mg Fasted Part B: MR-16h 480mg Fasted Part B: MR-16h 480 mg Fed (Std) Part B: MR-16h 480mg Fed (High-fat) Part B: MR-16h 480mg Fed (High-Fat) (Enteric Coated) Part B: MR-16h 960mg Fasted Part B: MR-16h 120mg Fasted
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      5/16 (31.25%)      3/16 (18.75%)      3/12 (25.00%)      3/16 (18.75%)      4/12 (33.33%)      8/16 (50.00%)      4/14 (28.57%)      1/15 (6.67%)      3/14 (21.43%)      3/15 (20.00%)      3/15 (20.00%)    
Eye disorders                         
Conjunctival haemorrhage  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/16 (6.25%)  1 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal disorders                         
Abdominal pain lower  1  0/16 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Vomiting  1  0/16 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Rectal haemorrhage  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Tooth loss  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
General disorders                         
Application site irritation  1  0/16 (0.00%)  0 0/16 (0.00%)  0 1/16 (6.25%)  1 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Chest discomfort  1  0/16 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Catheter site swelling  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Peripheral swelling  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Infections and infestations                         
Upper respiratory tract infection  1  1/16 (6.25%)  1 1/16 (6.25%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 2/12 (16.67%)  2 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Gastroenteritis  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/12 (8.33%)  1 1/16 (6.25%)  1 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Nasopharyngitis  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/12 (8.33%)  1 0/16 (0.00%)  0 1/12 (8.33%)  1 0/16 (0.00%)  0 0/14 (0.00%)  0 1/15 (6.67%)  1 1/14 (7.14%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Oral herpes  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/16 (6.25%)  1 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Injury, poisoning and procedural complications                         
Contusion  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Soft tissue injury  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Tooth fracture  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Investigations                         
Transaminases increased  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/16 (6.25%)  1 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Cardiac murmur  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders                         
Back pain  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/12 (8.33%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Musculoskeletal stiffness  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Nervous system disorders                         
Headache  1  1/16 (6.25%)  1 2/16 (12.50%)  2 1/16 (6.25%)  1 0/12 (0.00%)  0 2/16 (12.50%)  3 0/12 (0.00%)  0 3/16 (18.75%)  3 1/14 (7.14%)  1 0/15 (0.00%)  0 1/14 (7.14%)  1 2/15 (13.33%)  2 0/15 (0.00%)  0
Syncope  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/16 (6.25%)  1 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Psychiatric disorders                         
Depressed mood  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/16 (6.25%)  1 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Nightmare  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/16 (6.25%)  1 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                         
Nasal congestion  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 1/12 (8.33%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders                         
Rash  1  0/16 (0.00%)  0 1/16 (6.25%)  1 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Actinic keratosis  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 1/16 (6.25%)  1 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Vascular disorders                         
Haematoma  1  0/16 (0.00%)  0 0/16 (0.00%)  0 0/16 (0.00%)  0 0/12 (0.00%)  0 0/16 (0.00%)  0 1/12 (8.33%)  1 0/16 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/14 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03649412    
Other Study ID Numbers: 209261
2018-002370-48 ( EudraCT Number )
First Submitted: August 24, 2018
First Posted: August 28, 2018
Results First Submitted: April 8, 2020
Results First Posted: May 1, 2020
Last Update Posted: May 1, 2020