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Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis

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ClinicalTrials.gov Identifier: NCT01262898
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : October 13, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gastroparesis
Interventions Drug: GSK962040 (5 mg tablet)
Drug: GSK962040 (25 mg tablet)
Drug: GSK962040 (125 mg tablet)
Drug: Placebo
Enrollment 79
Recruitment Details A total of 80 participants were enrolled and randomized from 03 May 2011 to 26 Feb 2013. The study was conducted at 22 centers, 1 center in Australia, 1 center in Sweden, 2 centers in Belgium, 4 centers in Canada, 5 Centers in United Kingdom and 9 centers in United States.
Pre-assignment Details Out of 80 participants randomized, 1 participant withdrew consent prior to dosing in GSK962040 50 milligram (mg) arm. Remaining 79 participants were included in "All subject population"
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Period Title: Overall Study
Started 21 18 18 22
Completed 18 16 18 22
Not Completed 3 2 0 0
Reason Not Completed
Protocol Violation             1             1             0             0
Lost to Follow-up             1             0             0             0
Withdrawal by Subject             1             1             0             0
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg Total
Hide Arm/Group Description Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. Total of all reporting groups
Overall Number of Baseline Participants 21 18 18 22 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 18 participants 18 participants 22 participants 79 participants
54.6  (14.23) 54.0  (11.42) 55.2  (12.17) 51.4  (11.34) 53.7  (12.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 18 participants 22 participants 79 participants
Female
14
  66.7%
14
  77.8%
10
  55.6%
9
  40.9%
47
  59.5%
Male
7
  33.3%
4
  22.2%
8
  44.4%
13
  59.1%
32
  40.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 18 participants 22 participants 79 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.5%
1
   1.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   5.6%
1
   5.6%
1
   4.5%
3
   3.8%
Black or African American
2
   9.5%
2
  11.1%
0
   0.0%
0
   0.0%
4
   5.1%
White
19
  90.5%
15
  83.3%
17
  94.4%
20
  90.9%
71
  89.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Gastric Half Emptying Time (GEt1/2)
Hide Description Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 28, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled test meal. The test meal was consumed approximately 80 minutes(min) later. After consumption of the test meal, breath samples were collected at pre-specified time points over an approximately 4 hour period following the test meal. For the duration of the breath test, no food or drink were allowed. The 13C breath content was determined by isotope ratio mass spectrometry. GE t1/2 was determined by using the cumulative percentage of the administered dose of 13C excreted in breath over 4 hours.
Time Frame Screening2/Baseline (Day -30 to -1) , Day 1, and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ‘All Subjects Population’ compromised of all participants who received at least one dose of study medication. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Minutes
Baseline Number Analyzed 21 participants 18 participants 18 participants 22 participants
131.2  (25.31) 106.5  (23.42) 118.2  (31.13) 131.1  (32.66)
Day 1 Number Analyzed 21 participants 18 participants 18 participants 21 participants
124.1  (39.25) 106.6  (27.07) 104.8  (21.61) 99.4  (33.55)
Day 28 Number Analyzed 18 participants 16 participants 18 participants 22 participants
111.8  (24.37) 111.8  (32.23) 107.9  (29.03) 117.8  (44.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK962040 10 mg
Comments GSK962040 10 mg versus Placebo Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.36
Confidence Interval (2-Sided) 95%
-21.96 to 15.24
Parameter Dispersion
Type: Standard Deviation
Value: 14.47
Estimation Comments The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK962040 50 mg
Comments GSK962040 50 mg versus Placebo Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -11.81
Confidence Interval (2-Sided) 95%
-30.01 to 6.40
Parameter Dispersion
Type: Standard Deviation
Value: 14.47
Estimation Comments The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK962040 125 mg
Comments GSK962040 125 mg versus Placebo Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -25.65
Confidence Interval (2-Sided) 95%
-42.99 to -8.32
Parameter Dispersion
Type: Standard Deviation
Value: 14.47
Estimation Comments The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK962040 10 mg
Comments GSK962040 10 mg versus Placebo Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 14.74
Confidence Interval (2-Sided) 95%
-5.06 to 34.53
Parameter Dispersion
Type: Standard Deviation
Value: 14.47
Estimation Comments The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK962040 50 mg
Comments GSK962040 50 mg vs Placebo Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.22
Confidence Interval (2-Sided) 95%
-14.64 to 23.08
Parameter Dispersion
Type: Standard Deviation
Value: 14.47
Estimation Comments The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GSK962040 125 mg
Comments GSK962040 125 mg versus Placebo Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.65
Confidence Interval (2-Sided) 95%
-11.18 to 24.47
Parameter Dispersion
Type: Standard Deviation
Value: 14.47
Estimation Comments The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo
Comments Day 28 versus Day 1 of the Placebo arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -12.92
Confidence Interval (2-Sided) 95%
-28.73 to 2.90
Parameter Dispersion
Type: Standard Deviation
Value: 14.47
Estimation Comments The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK962040 10 mg
Comments Day 28 versus Day 1 of GSK962040 10 mg arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.18
Confidence Interval (2-Sided) 95%
-11.69 to 22.05
Parameter Dispersion
Type: Standard Deviation
Value: 14.47
Estimation Comments The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK962040 50 mg
Comments Day 28 versus Day 1 of GSK962040 50 mg arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.11
Confidence Interval (2-Sided) 95%
-13.13 to 19.36
Parameter Dispersion
Type: Standard Deviation
Value: 14.47
Estimation Comments The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection GSK962040 125 mg
Comments Day 28 versus Day 1 of GSK962040 125 mg arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 19.39
Confidence Interval (2-Sided) 95%
4.47 to 34.30
Parameter Dispersion
Type: Standard Deviation
Value: 14.47
Estimation Comments The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GSK962040 10 mg, GSK962040 50 mg, GSK962040 125 mg
Comments Type 1 Diabetes, Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.225
Confidence Interval (2-Sided) 95%
-0.320 to -0.129
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, GSK962040 10 mg, GSK962040 50 mg, GSK962040 125 mg
Comments Type 1 Diabetes, Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.078
Confidence Interval (2-Sided) 95%
-0.171 to 0.016
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, GSK962040 10 mg, GSK962040 50 mg, GSK962040 125 mg
Comments Type 2 Diabetes, Day 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.225
Confidence Interval (2-Sided) 95%
-0.320 to -0.129
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, GSK962040 10 mg, GSK962040 50 mg, GSK962040 125 mg
Comments Type 2 Diabetes, Day 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.078
Confidence Interval 95%
-0.171 to 0.016
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With On-treatment Adverse Events (AES) and Serious Adverse Events(SAEs)
Hide Description An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Data for on-treatment adverse events is reported.
Time Frame Up to follow-up (5-10 days post last dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects population.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Measure Type: Number
Unit of Measure: Participants
Any on-treatment AEs 13 14 13 18
Any on-treatment SAEs 1 0 1 0
3.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure(DBP) at Specified Time Points in Semi-supine Position
Hide Description Blood pressure measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The Baseline value was Day 1 Pre-Dose values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline, Day 1, and Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
SBP Day 1 3.5 hours Number Analyzed 13 participants 13 participants 13 participants 15 participants
0.6  (13.68) -1.8  (17.50) 0.8  (18.07) -2.3  (8.85)
SBP Day 28 3.5 hours Number Analyzed 11 participants 13 participants 13 participants 15 participants
3.2  (12.09) -1.1  (15.56) 4.6  (16.47) -7.2  (11.62)
DBP Day 1 3.5 hours Number Analyzed 13 participants 13 participants 13 participants 15 participants
-2.5  (8.09) 1.1  (7.45) -0.7  (8.50) -2.3  (5.19)
DBP Day 28 3.5 hours Number Analyzed 11 participants 13 participants 13 participants 15 participants
-0.3  (4.69) -0.8  (8.62) 2.7  (6.33) -6.1  (7.32)
4.Secondary Outcome
Title Change From Baseline in Heart Rate at Specified Time Points in Semi-supine Position
Hide Description Heart rate measurements were taken at pre-dose and 120 min (completion of meal) on Day 1 and Day 28. The Baseline value was Day 1 Pre-Dose values . Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline, Day 1, and Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Beats per minute (BPM)
Heart rate Day 1 3.5 hours Number Analyzed 13 participants 13 participants 13 participants 15 participants
-0.3  (7.60) -0.8  (6.64) -0.3  (8.39) 2.1  (6.31)
Heart rate Day 28 3.5 hours Number Analyzed 11 participants 13 participants 13 participants 15 participants
-3.9  (6.86) -1.5  (6.94) 1.0  (9.09) 0.7  (8.26)
5.Secondary Outcome
Title Change From Baseline in Electrocardiography Parameters (12-lead ECG)
Hide Description ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 28. The Baseline value was the Day 1 pre-dose value. ECG parameters included PR interval, QRS duration, QT interval, QTcB, QTcF and RR interval.
Time Frame Baseline, Day 1 and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Milliseconds (msec)
PR interval Day 1 1.5 hours Number Analyzed 19 participants 18 participants 17 participants 22 participants
-2.6  (10.40) 3.2  (7.46) 0.5  (13.03) -0.9  (9.68)
PR interval Day 14 pre-dose Number Analyzed 19 participants 16 participants 17 participants 22 participants
-5.5  (7.39) 0.6  (7.87) -1.6  (11.29) -3.1  (9.25)
PR interval Day 28 pre-dose Number Analyzed 19 participants 16 participants 17 participants 22 participants
2.4  (17.12) -7.1  (26.93) 2.2  (18.32) -0.1  (8.14)
PR interval Day 28 1.5 hours Number Analyzed 18 participants 15 participants 17 participants 21 participants
1.2  (14.28) 0.5  (11.48) 3.6  (16.71) -4.3  (9.54)
QRS duration Day 1 1.5 hours Number Analyzed 21 participants 18 participants 18 participants 22 participants
0.2  (5.18) -0.6  (4.16) 0.1  (4.07) 0.6  (5.22)
QRS duration Day 14 pre-dose Number Analyzed 20 participants 16 participants 18 participants 22 participants
0.1  (5.26) -0.8  (4.33) -0.1  (3.57) -0.9  (4.97)
QRS duration Day 28 pre-dose Number Analyzed 19 participants 16 participants 18 participants 22 participants
2.4  (4.93) 1.1  (4.54) -0.3  (3.84) 1.0  (4.81)
QRS duration Day 28 1.5 hours Number Analyzed 18 participants 15 participants 18 participants 21 participants
0.8  (4.29) 0.6  (3.98) -0.3  (4.96) 0.0  (4.97)
QT interval Day 1 1.5 hours Number Analyzed 21 participants 18 participants 18 participants 22 participants
1.0  (12.30) -0.2  (17.45) -3.8  (13.16) 1.6  (12.64)
QT interval Day 14 pre-dose Number Analyzed 20 participants 16 participants 18 participants 22 participants
-8.8  (18.52) -9.6  (19.11) -10.7  (25.58) -9.6  (19.87)
QT interval Day 28 pre-dose Number Analyzed 19 participants 16 participants 18 participants 22 participants
0.3  (21.83) -5.0  (21.36) -2.0  (23.20) -3.0  (20.29)
QT interval Day 28 1.5 hours Number Analyzed 18 participants 15 participants 18 participants 21 participants
4.9  (16.37) -2.8  (22.18) -1.3  (26.49) -4.5  (21.38)
QTcB Day 1 1.5 hours Number Analyzed 21 participants 17 participants 17 participants 22 participants
-2.84  (13.906) -1.94  (13.721) -2.45  (13.447) -0.12  (15.771)
QTcB Day 14 pre-dose Number Analyzed 20 participants 15 participants 17 participants 22 participants
3.23  (11.503) -2.97  (12.075) -2.68  (18.410) -1.42  (16.245)
QTcB Day 28 pre-dose Number Analyzed 19 participants 15 participants 17 participants 22 participants
-3.85  (20.907) 2.71  (9.741) 1.31  (18.419) -0.20  (15.062)
QTcB Day 28 1.5 hours Number Analyzed 18 participants 14 participants 17 participants 21 participants
1.59  (24.246) 1.86  (14.682) -0.16  (17.208) -0.88  (15.216)
QTcF Day 1 1.5 hours Number Analyzed 21 participants 17 participants 17 participants 22 participants
-1.52  (12.089) -1.26  (14.709) -2.84  (11.080) 0.72  (12.418)
QTcF Day 14 pre-dose Number Analyzed 20 participants 15 participants 17 participants 22 participants
-1.02  (11.942) -5.57  (12.599) -5.91  (19.109) -4.37  (13.314)
QTcF Day 28 pre-dose Number Analyzed 19 participants 15 participants 17 participants 22 participants
-2.55  (18.782) 0.04  (12.835) 0.96  (15.942) -1.21  (12.490)
QTcF Day 28 1.5 hours Number Analyzed 18 participants 14 participants 17 participants 21 participants
2.70  (20.473) -0.24  (14.344) -0.64  (16.857) -2.17  (12.797)
RR interval Day 1 1.5 hours Number Analyzed 21 participants 17 participants 17 participants 22 participants
16.82  (56.084) 7.26  (44.025) -3.26  (68.824) 8.74  (81.926)
RR interval Day 14 pre-dose Number Analyzed 20 participants 15 participants 17 participants 22 participants
-54.61  (76.965) -33.95  (75.539) -42.92  (90.333) -35.25  (102.822)
RR interval Day 28 pre-dose Number Analyzed 19 participants 15 participants 17 participants 22 participants
18.15  (109.227) -31.14  (75.740) -3.31  (99.049) -11.51  (108.680)
RR interval Day 28 1.5 hours Number Analyzed 18 participants 14 participants 17 participants 21 participants
13.96  (76.906) -23.69  (96.568) -4.08  (114.019) -15.60  (108.056)
6.Secondary Outcome
Title Number of Participants Outside the Normal Range for SBP and DBP
Hide Description Blood pressure measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The clinical concern range (CCR) for SBP was greater than (<) 85 and less than (>) 160 and for DBP the range was <45 and >100. Data for semi-supine position has been presented. Baseline was Screening2/Baseline values.
Time Frame Screening2/Baseline (Day -30 to -1), Day 1 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Measure Type: Number
Unit of Measure: Participants
SBP Screening 3.5 hours < CCR Number Analyzed 13 participants 13 participants 13 participants 15 participants
0 0 0 0
SBP Screening 3.5 hours>CCR Number Analyzed 13 participants 13 participants 13 participants 15 participants
0 1 0 0
SBP Day 1 3.5 hours< CCR Number Analyzed 14 participants 15 participants 16 participants 20 participants
0 0 1 0
SBP Day 1 3.5 hours>CCR Number Analyzed 14 participants 15 participants 16 participants 20 participants
0 1 0 0
SBP Day 28 3.5 hours< CCR Number Analyzed 12 participants 15 participants 17 participants 20 participants
0 0 0 0
SBP Day 28 3.5 hours>CCR Number Analyzed 12 participants 15 participants 17 participants 20 participants
0 1 0 0
DBP Screening 3.5 hours< CCR Number Analyzed 13 participants 13 participants 13 participants 15 participants
0 0 0 0
DBP Screening 3.5 hours>CCR Number Analyzed 13 participants 13 participants 13 participants 15 participants
0 0 0 0
DBP Day 1 3.5 hours Number Analyzed 14 participants 15 participants 16 participants 20 participants
0 0 0 0
DBP Day 1 3.5 hours - 2 Number Analyzed 21 participants 18 participants 18 participants 22 participants
0 0 0 0
DBP Day 28 3.5 hours Number Analyzed 12 participants 15 participants 17 participants 20 participants
0 0 0 0
DBP Day 28 3.5 hours - 2 Number Analyzed 21 participants 18 participants 18 participants 22 participants
0 0 0 0
7.Secondary Outcome
Title Number of Participants Outside the Normal Range for Heart Rate
Hide Description Heart rate measurements were taken at pre-dose and at 120 min (completion of meal) on Day 1 and Day 28. The CCR for heart rate was Increase or decrease by less than or equal to (>=) 15 and >= 30. Data for semi-supine position has been presented. Baseline was Screening2/Baseline values.
Time Frame Screening2/Baseline (Day -30 to -1), Day 1 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Measure Type: Number
Unit of Measure: Participants
Heart rate Screening 3.5 hours <CCR Number Analyzed 13 participants 13 participants 13 participants 15 participants
0 0 0 0
Heart rate Screening 3.5 hours >CCR Number Analyzed 13 participants 13 participants 13 participants 15 participants
0 0 0 0
Heart rate Day 1 3.5 hours <CCR Number Analyzed 14 participants 15 participants 16 participants 20 participants
0 0 0 0
Heart rate Day 1 3.5 hours >CCR Number Analyzed 14 participants 15 participants 16 participants 20 participants
0 0 0 0
Heart rate Day 28 3.5 hours<CCR Number Analyzed 12 participants 15 participants 17 participants 20 participants
0 0 0 0
Heart rate Day 28 3.5 hours> CCR Number Analyzed 12 participants 15 participants 17 participants 20 participants
0 0 0 0
8.Secondary Outcome
Title Number of Participants Outside the Normal Range for 12-lead ECG
Hide Description ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 28. The CCR for ECG parameters were: PR interval (<110 and >220), QRS interval (<75 and >110), Absolute QTc interval (>450 to =< 480) respectively. Baseline was the pre-dose reading for Day 1. Data for abnormal- clinically significant (ACS) and abnormal- not clinically significant (ANCS) has been presented.
Time Frame Baseline (Day 1 pre-dose), Day 1, Day 14 and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Measure Type: Number
Unit of Measure: Participants
Day 1 pre-dose ANCS Number Analyzed 21 participants 18 participants 18 participants 22 participants
6 7 6 5
Day 1 pre-dose ACS Number Analyzed 21 participants 18 participants 18 participants 22 participants
0 0 0 0
Day 1 1.5 hour ANCS Number Analyzed 21 participants 18 participants 18 participants 22 participants
6 8 6 6
Day 1 1.5 hour ACS Number Analyzed 21 participants 18 participants 18 participants 22 participants
0 0 0 0
Day 14 pre-dose ANCS Number Analyzed 20 participants 16 participants 18 participants 22 participants
7 7 5 7
Day 14 pre-dose ACS Number Analyzed 20 participants 16 participants 18 participants 22 participants
0 0 0 0
Day 28 pre-dose ANCS Number Analyzed 19 participants 16 participants 18 participants 22 participants
7 5 4 5
Day 28 pre-dose ACS Number Analyzed 19 participants 16 participants 18 participants 22 participants
0 0 0 0
Day 28 1.5 hour ANCS Number Analyzed 18 participants 15 participants 18 participants 21 participants
7 6 5 5
Day 28 1.5 hour ACS Number Analyzed 18 participants 15 participants 18 participants 21 participants
0 0 0 0
9.Secondary Outcome
Title Mean Change From Baseline in Clinical Chemistry: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Gamma Glutamyl Transferase, Creatine Kinase, Lactate Dehydrogenase
Hide Description Alkaline phosphatase, alanine amino transferase, aspartate amino transferase, gamma glutamyl transferase, creatine kinase, lactate dehydrogenase measurements were taken at Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: International units per liter (IU/L)
Alkaline Phosphatase Day 5 Number Analyzed 20 participants 16 participants 18 participants 21 participants
3.0  (7.54) 4.3  (7.20) 4.0  (9.27) -1.1  (23.56)
Alkaline Phosphatase Day 10 Number Analyzed 19 participants 16 participants 18 participants 21 participants
2.7  (8.63) 5.0  (7.79) 2.8  (10.58) -1.3  (26.28)
Alkaline Phosphatase Day 14 Number Analyzed 19 participants 16 participants 18 participants 22 participants
3.7  (9.17) 5.0  (8.16) 0.7  (8.70) -4.3  (24.67)
Alkaline Phosphatase Day 21 Number Analyzed 18 participants 16 participants 18 participants 22 participants
4.3  (15.25) 3.9  (9.19) 1.7  (11.39) -1.7  (26.96)
Alkaline Phosphatase Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
1.1  (14.05) 3.1  (7.17) -2.5  (14.66) -1.7  (25.23)
Alanine Amino Transferase Day 5 Number Analyzed 20 participants 16 participants 18 participants 21 participants
0.7  (3.28) 2.6  (7.31) 2.8  (10.88) -1.1  (16.03)
Alanine Amino Transferase Day 10 Number Analyzed 19 participants 16 participants 18 participants 21 participants
0.6  (7.86) 2.5  (6.60) -1.2  (4.93) -1.1  (17.05)
Alanine Amino Transferase Day 14 Number Analyzed 19 participants 16 participants 18 participants 22 participants
2.4  (7.32) 2.9  (6.99) -1.0  (6.94) -3.2  (15.94)
Alanine Amino Transferase Day 21 Number Analyzed 18 participants 16 participants 18 participants 22 participants
-0.4  (6.74) 0.3  (6.09) -0.1  (5.89) -2.9  (14.59)
Alanine Amino Transferase Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
-1.5  (5.39) 1.1  (6.22) -1.2  (6.88) -4.0  (13.60)
Aspartate Amino Transferase Day 5 Number Analyzed 21 participants 18 participants 18 participants 22 participants
-0.3  (5.68) 0.1  (6.73) -1.9  (9.90) 1.6  (4.56)
Aspartate Amino Transferase Day 10 Number Analyzed 19 participants 16 participants 18 participants 21 participants
0.5  (9.08) 1.2  (8.27) -2.7  (10.67) 2.8  (3.43)
Aspartate Amino Transferase Day 14 Number Analyzed 19 participants 16 participants 18 participants 22 participants
2.6  (5.50) -1.1  (6.94) -2.8  (11.35) 1.0  (6.36)
Aspartate Amino Transferase Day 21 Number Analyzed 18 participants 16 participants 18 participants 22 participants
-1.1  (6.80) -0.3  (6.78) -1.2  (9.55) 1.6  (5.12)
Aspartate Amino Transferase Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
-0.8  (6.63) 0.4  (5.41) -2.7  (9.13) 0.5  (6.61)
Gamma Glutamyl Transferase Day 5 Number Analyzed 20 participants 14 participants 13 participants 18 participants
-0.5  (2.43) 1.8  (4.35) 1.6  (6.26) 2.4  (8.44)
Gamma Glutamyl Transferase Day 10 Number Analyzed 18 participants 15 participants 13 participants 20 participants
-1.1  (2.88) 0.5  (4.16) 1.8  (7.09) 1.2  (6.79)
Gamma Glutamyl Transferase Day 14 Number Analyzed 20 participants 14 participants 16 participants 20 participants
-0.2  (4.57) 0.4  (3.10) 2.1  (6.55) 1.5  (8.95)
Gamma Glutamyl Transferase Day 21 Number Analyzed 17 participants 15 participants 14 participants 20 participants
-0.3  (5.11) -1.3  (5.00) 1.8  (3.52) 2.6  (7.93)
Gamma Glutamyl Transferase Day 28 Number Analyzed 19 participants 15 participants 17 participants 21 participants
-1.7  (5.44) 0.5  (5.51) 0.3  (4.37) 4.2  (16.01)
Creatine Kinase Day 28 Number Analyzed 17 participants 11 participants 11 participants 17 participants
-4.3  (61.05) 41.9  (74.29) 42.0  (103.49) 0.2  (42.14)
Lactate Dehydrogenase Day 28 Number Analyzed 16 participants 12 participants 12 participants 17 participants
-11.5  (38.69) 8.6  (31.10) -5.8  (42.29) -16.2  (40.37)
10.Secondary Outcome
Title Mean Change From Baseline in Clinical Chemistry: Direct Bilirubin, Total Bilirubin, Creatinine, Uric Acid
Hide Description Direct Bilirubin, Total Bilirubin, Creatinine, Uric acid measurements were taken at Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Unit moles per litre (UMOL/L)
Direct Bilirubin Day 5 Number Analyzed 20 participants 15 participants 14 participants 19 participants
0.1  (0.75) -0.2  (1.27) -0.1  (0.62) -0.0  (1.38)
Direct Bilirubin Day 10 Number Analyzed 19 participants 13 participants 14 participants 19 participants
0.1  (0.75) 0.0  (1.65) -0.1  (0.75) -0.0  (1.10)
Direct Bilirubin Day 14 Number Analyzed 20 participants 14 participants 14 participants 20 participants
0.1  (0.57) 0.1  (1.19) -0.2  (0.70) -0.0  (1.21)
Direct Bilirubin Day 21 Number Analyzed 17 participants 14 participants 14 participants 20 participants
0.1  (0.75) 0.2  (1.35) -0.2  (0.90) 0.1  (1.03)
Direct Bilirubin Day 28 Number Analyzed 19 participants 14 participants 14 participants 19 participants
0.1  (0.74) 0.3  (1.57) 0.1  (0.98) -0.1  (0.84)
Total Bilirubin Day 5 Number Analyzed 20 participants 16 participants 18 participants 21 participants
0.2  (2.43) 0.4  (2.71) -2.6  (3.41) -0.5  (3.19)
Total Bilirubin Day 10 Number Analyzed 19 participants 16 participants 18 participants 21 participants
-0.4  (2.25) -0.1  (3.13) -1.8  (4.83) -0.4  (2.57)
Total Bilirubin Day 14 Number Analyzed 19 participants 16 participants 18 participants 22 participants
0.5  (2.41) 0.2  (2.99) -2.1  (3.15) -0.3  (2.99)
Total Bilirubin Day 21 Number Analyzed 18 participants 16 participants 18 participants 22 participants
-0.6  (2.53) 0.4  (3.72) -1.2  (3.49) -0.2  (1.99)
Total Bilirubin, Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
0.0  (1.87) 1.2  (3.45) -0.6  (2.71) -0.9  (3.27)
Creatinine Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
-2.91  (6.156) 0.51  (7.415) 9.42  (17.103) 9.80  (11.993)
Uric acid Day 28 Number Analyzed 19 participants 15 participants 17 participants 22 participants
-8.61  (39.359) 3.56  (32.183) 8.62  (25.412) 18.29  (39.987)
11.Secondary Outcome
Title Mean Change From Baseline in Clinical Chemistry : Albumin, Total Protein
Hide Description Albumin, Total Protein measurements were taken at Baseline (Day 1 pre-dose), and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline (Day 1 pre-dose) and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Grams per liter (g/L)
Albumin Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
-0.68  (2.335) 0.49  (2.040) 0.11  (1.323) -0.66  (2.308)
Total Protein Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
-0.3  (3.79) 0.7  (2.94) 1.0  (2.68) -0.5  (4.53)
12.Secondary Outcome
Title Mean Change From Baseline in Clinical Chemistry : Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN, Carbon Dioxide Content/Bicarbonate
Hide Description Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN, Carbon dioxide content/Bicarbonate measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline (Day 1 pre-dose) and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Millimoles per liter (MMOL/L)
Calcium Day 28 Number Analyzed 19 participants 16 participants 17 participants 22 participants
-0.018  (0.1067) -0.017  (0.0764) 0.027  (0.0666) -0.031  (0.1323)
Chloride Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
0.26  (3.754) -0.93  (3.137) -0.94  (2.578) 0.15  (2.759)
Glucose Day 28 Number Analyzed 18 participants 16 participants 18 participants 22 participants
-0.21  (4.343) 0.24  (3.638) 0.66  (6.790) -0.25  (2.332)
Potassium Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
-0.042  (0.3564) 0.094  (0.6002) -0.111  (0.5132) -0.068  (0.3999)
Sodium Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
-0.42  (3.203) -0.41  (2.303) -0.56  (2.833) 0.00  (1.718)
Urea/BUN Day 28 Number Analyzed 17 participants 12 participants 15 participants 19 participants
-0.35  (2.021) -0.31  (1.778) -0.04  (1.942) 0.26  (2.016)
Carbon dioxide content/Bicarbonate Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
-0.21  (1.843) -0.79  (2.286) 1.17  (2.526) -0.08  (2.298)
13.Secondary Outcome
Title Mean Change From Baseline in Hematology Parameters : Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count), Platelet Count, White Blood Cell Count
Hide Description Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC - Total Absolute Neutrophil Count), Platelet count, White Blood cell count measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline (Day 1 pre-dose) and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Giga (10^9) cells per liter (GI/L)
Basophils Day 28 Number Analyzed 19 participants 16 participants 16 participants 21 participants
0.0066  (0.03852) -0.0388  (0.09539) -0.0322  (0.07998) 0.1072  (0.43592)
Eosinophils Day 28 Number Analyzed 19 participants 16 participants 17 participants 21 participants
-0.0167  (0.07137) 0.0431  (0.11412) -0.0040  (0.18975) 0.1173  (0.41877)
Lymphocytes Day 28 Number Analyzed 19 participants 16 participants 18 participants 21 participants
0.0485  (0.44972) -0.0561  (0.45151) 0.1887  (0.31662) -0.0099  (0.34075)
Monocytes Day 28 Number Analyzed 19 participants 16 participants 18 participants 21 participants
-0.0327  (0.16668) -0.0530  (0.09965) -0.0097  (0.17272) -0.0298  (0.10623)
Total Neutrophils Day 28 Number Analyzed 19 participants 16 participants 18 participants 21 participants
0.1380  (0.78256) 0.2159  (1.28307) 0.2949  (1.20093) -0.7640  (1.97899)
Platelet count Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
6.4  (32.76) 1.5  (35.37) 0.6  (28.87) -2.0  (21.58)
White Blood cell count Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
0.144  (1.0951) 0.225  (1.4369) 0.428  (1.0110) -0.730  (2.0794)
14.Secondary Outcome
Title Mean Change From Baseline in Hematology Parameters : Hematocrit
Hide Description Hematocrit measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline (Day 1 pre-dose) and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 19 16 18 22
Mean (Standard Deviation)
Unit of Measure: Ratio
-0.0025  (0.01692) 0.0021  (0.01053) 0.0019  (0.01508) -0.0059  (0.01637)
15.Secondary Outcome
Title Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Hemoglobin
Hide Description Mean Corpuscle Hemoglobin measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline (Day 1 pre-dose) and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 17 14 15 19
Mean (Standard Deviation)
Unit of Measure: Picograms (Pg)
0.05  (0.521) 0.15  (0.454) -0.15  (0.667) -0.14  (0.643)
16.Secondary Outcome
Title Mean Change From Baseline in Hematology Parameters : Hemoglobin, Mean Corpuscle Hemoglobin Concentration
Hide Description Hemoglobin, Mean Corpuscle Hemoglobin concentration measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline (Day 1 pre-dose) and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: g/L
Hemoglobin Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
0.4  (5.36) 1.1  (4.63) -0.2  (5.46) -2.7  (5.11)
Mean Corpuscle Hemoglobin concentration Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
2.8  (6.20) 1.6  (4.92) -2.8  (6.53) -1.9  (7.81)
17.Secondary Outcome
Title Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Volume
Hide Description Mean Corpuscle Volume measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline (Day 1 pre-dose) and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 19 16 18 22
Mean (Standard Deviation)
Unit of Measure: Femtoliters (FL)
-0.52  (0.952) -0.24  (1.163) 0.43  (1.514) 0.13  (1.318)
18.Secondary Outcome
Title Mean Change From Baseline in Hematology Parameters : Red Blood Cell Count, Reticulocytes
Hide Description Red Blood Cell count, Reticulocytes measurements were taken at Baseline (Day 1 pre-dose) and Day 28. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline (Day 1 pre-dose) and Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Tera (10^12) cells per liter (TI/L)
Red Blood Cell count Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
0.003  (0.2015) 0.035  (0.1399) 0.003  (0.1597) -0.072  (0.1660)
Reticulocytes Day 28 Number Analyzed 19 participants 16 participants 18 participants 22 participants
-0.0080  (0.02949) -0.0051  (0.01418) 0.0070  (0.01919) -0.0050  (0.01937)
19.Secondary Outcome
Title Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration AUC(0-t) at Specified Time Points
Hide Description AUC(0-t) was derived from GSK962040 plasma concentration-time data. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.Only participants who received GSK962040 drug were analyzed.
Time Frame Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ‘Pharmacokinetic (PK) Population' was defined as participants in the ‘All subjects’ population for whom a PK sample was obtained and analyzed. Only those participants available at specified time points were analyzed.
Arm/Group Title GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 18 18 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms.hour/milliliter (ng.h/mL)
Day 1 Number Analyzed 15 participants 18 participants 21 participants
854.9
(36.6%)
4083.1
(23.6%)
12911.9
(30.0%)
Day 28 Number Analyzed 15 participants 15 participants 21 participants
1908.1
(46.1%)
7347.2
(24.3%)
22173.3
(31.8%)
20.Secondary Outcome
Title Maximum Observed Concentration (Cmax) at Specified Time Points
Hide Description Cmax is defined as the maximum observed drug concentration after administration. Cmax was determined directly from the raw concentration-time data. Samples were collected at the following times: Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose.
Time Frame Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population. Only those participants available at specified time points were analyzed.
Arm/Group Title GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 18 18 22
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanograms per milliliter (ng/mL)
Day 1 Number Analyzed 15 participants 18 participants 21 participants
70.21
(54.7%)
385.73
(27.6%)
1239.62
(40.0%)
Day 28 Number Analyzed 15 participants 15 participants 21 participants
131.71
(52.9%)
530.97
(34.0%)
1703.29
(38.0%)
21.Secondary Outcome
Title Time of Occurrence of Cmax (Tmax) at Specified Time Points
Hide Description Tmax is defined as the time to reach the observed maximum concentration. Samples were collected at the following times: Tmax was determined directly from the raw concentration-time data. Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose.
Time Frame Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population. Only those participants available at specified time points were analyzed.
Arm/Group Title GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 18 18 22
Mean (Standard Deviation)
Unit of Measure: Hour
Day 1 Number Analyzed 15 participants 18 participants 21 participants
2.174  (0.9066) 2.238  (1.0697) 2.092  (0.8419)
Day 28 Number Analyzed 15 participants 15 participants 21 participants
2.189  (1.3976) 2.168  (0.7224) 2.026  (1.2038)
22.Secondary Outcome
Title Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ct) at Specified Time Points
Hide Description Analysis of pre-dose (trough) concentration at the end of the dosing interval (Ct) was planned to be performed from the samples collected at Pre -dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28.
Time Frame Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK population.
Arm/Group Title GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 18 18 22
Mean (Standard Deviation)
Unit of Measure: Liters
Day 14 Number Analyzed 14 participants 18 participants 21 participants
63.73  (34.853) 214.26  (146.572) 537.23  (290.370)
Day 28 Number Analyzed 15 participants 15 participants 21 participants
62.60  (32.830) 205.03  (84.251) 597.39  (321.225)
23.Secondary Outcome
Title Apparent Clearance Following Oral Dosing (CL/F) at Specified Time Points
Hide Description CL/F was calculated as dose/AUC. The parameter was planned to be analyzed from samples collected at Pre -dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28, however the data for this outcome measure was not collected.
Time Frame Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population. The data for this outcome measure was not collected.
Arm/Group Title GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Secondary Outcome
Title Apparent Volume of Distribution (V/F) at Specified Time Points
Hide Description The apparent volume of distribution V/F = CL/F × MRT, where MRT is the mean residence time. The parameter was planned to be analyzed using samples collected at Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28, however, the data for this outcome measure was not collected.
Time Frame Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population. The data for this outcome measure was not collected.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Apparent Terminal Elimination Half-life (t1/2) at Specified Time Points
Hide Description This outcome measure was not analyzed in results.
Time Frame The parameter was planned to be analyzed using samples collected at Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28, however, the data for this outcome measure was not collected.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Population. The data for this outcome measure was not collected.
Arm/Group Title GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title Time to First Bowel Movement After First Dose
Hide Description The time to first bowel movement was calculated as the time of the first bowel movement after the first dose in hours (floored) for each participant. If a participant had fewer than 5 days worth of data then the daily mean for that week was set to missing for the following two parameters: Bowel Movement Count and Stool Consistency. Seventeen participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics of time to first bowel movement.
Time Frame Up to Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 16 12 15 12
Mean (Standard Deviation)
Unit of Measure: hours
28.94  (25.044) 53.98  (67.901) 17.52  (19.286) 15.73  (15.648)
27.Secondary Outcome
Title Daily Bowel Movement Frequency
Hide Description Daily bowel movement frequency analyzed number of times passed stools in 24 hours of duration. Following dosing with study medication, stool monitoring was performed up to Day 28. Seventeen participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics.
Time Frame Up to Week 4 (Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Bowel movements/24 hours
Week 1 Number Analyzed 19 participants 11 participants 17 participants 21 participants
1.30  (0.872) 1.33  (0.812) 1.50  (0.943) 1.39  (0.729)
Week 2 Number Analyzed 20 participants 14 participants 17 participants 22 participants
2.23  (3.473) 1.59  (0.948) 1.55  (1.012) 1.45  (0.883)
Week 3 Number Analyzed 19 participants 15 participants 17 participants 22 participants
2.18  (3.269) 1.44  (0.830) 1.77  (1.172) 1.38  (0.770)
Week 4 Number Analyzed 17 participants 16 participants 17 participants 21 participants
2.11  (3.432) 1.54  (0.841) 1.68  (1.049) 1.37  (0.831)
28.Secondary Outcome
Title Daily Average Stool Consistency
Hide Description Stool consistency was determined on a scale of 1 to 5 (1 = Very hard, 2 = Hard, 3 = Formed, 4 = Loose, 5 = Watery). Following dosing with study medication, stool monitoring was performed up to Day 28. Participants who entered their time of first instance of bowel movement before taking first dose were excluded from the summary statistics.
Time Frame Up to Week 4 (Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Bowel Movements/ 24 hours
Week 1 Number Analyzed 9 participants 7 participants 11 participants 13 participants
2.91  (0.817) 3.24  (0.524) 2.80  (0.815) 3.71  (0.874)
Week 2 Number Analyzed 13 participants 11 participants 13 participants 17 participants
2.98  (0.730) 2.81  (0.673) 3.05  (0.798) 3.29  (0.724)
Week 3 Number Analyzed 14 participants 12 participants 12 participants 16 participants
2.89  (0.517) 2.87  (0.889) 2.99  (0.558) 3.26  (0.683)
Week 4 Number Analyzed 12 participants 13 participants 12 participants 14 participants
2.92  (0.528) 2.96  (0.625) 2.98  (0.502) 3.37  (0.569)
29.Secondary Outcome
Title Change From Baseline in Upper Gastrointestinal (GI) Symptoms as Assessed by Total Gastrointestinal Cardinal Symptom Index – Daily Diary (GCSI–DD)
Hide Description GCSI–DD was measured on a 6-point scale. The Total GCSI-DD score was the mean of the following three subscales: Nausea/Vomiting Subscale = mean (nausea, retching, vomiting), Fullness/Early Satiety Subscale = mean (feeling excessively full after meals, not able to finish a normal-sized meal, stomach fullness, loss of appetite), Bloating Subscale = mean (bloating, stomach or belly visibly larger). Each subscale was scored on a severity scale of 0 (none) to 5 (very severe), with lower scores representing less symptom severity. The change from Baseline to each study week in average score was derived and if it improved by 1 point or more, that participant was defined as “responder” for that symptom and on that particular week. Baseline was Screening2/Baseline values (Day -30 to -1). Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Up to 14 days post last dose (Day 28)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Week 1 Number Analyzed 19 participants 11 participants 17 participants 21 participants
-0.48  (0.645) -0.46  (0.676) -0.58  (0.379) -0.57  (0.491)
Week 2 Number Analyzed 20 participants 14 participants 17 participants 22 participants
-0.68  (0.728) -1.04  (1.062) -1.21  (0.663) -0.72  (0.597)
Week 3 Number Analyzed 19 participants 15 participants 17 participants 22 participants
-0.75  (0.770) -1.29  (0.936) -1.16  (0.745) -0.77  (0.654)
Week 4 Number Analyzed 16 participants 16 participants 16 participants 22 participants
-0.86  (1.001) -1.32  (0.980) -1.12  (0.670) -0.82  (0.727)
Week 5 Number Analyzed 18 participants 15 participants 16 participants 22 participants
-0.87  (0.951) -1.19  (0.906) -1.07  (0.738) -0.74  (0.728)
Week 6 Number Analyzed 17 participants 13 participants 14 participants 21 participants
-0.85  (0.943) -0.96  (1.000) -0.86  (0.632) -0.59  (0.776)
30.Secondary Outcome
Title Change From Baseline in Whole Bowel Transit Time, 100 % Gastric Emptying Time (Truncated at 240 Minutes), Small Bowel Transit Time, Colonic Transit Time as Determined by Wireless Motility Capsule (WMC)
Hide Description WMC is an ingestible telemetric capsule which measures pH, pressure and temperature to assess total gastric emptying time, small and large bowel transit time, colonic transit time, and whole gut transit time. The WMC was ingested immediately following the standard test meal for the oral breath test. Data was collected on a data logger, which was worn on a belt clip. The WMC passed naturally in the participant’s stools between 2 and 5 days after ingestion. The parameters Whole bowel transit time, 100 % gastric emptying time (truncated at 240 minutes), small bowel transit time, colonic transit time were analyzed. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.
Time Frame Baseline(Screening i.e., Day -30 to -1), Day 1 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Only those participants available at specified time points were analyzed.
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description:
Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days.
Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days.
Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
Overall Number of Participants Analyzed 21 18 18 22
Mean (Standard Deviation)
Unit of Measure: minutes
100% Gastric Emptying Time Day 1 Number Analyzed 16 participants 15 participants 16 participants 22 participants
-159.9  (616.67) -240.3  (567.18) -323.8  (461.05) -381.0  (541.73)
100% Gastric Emptying Time Day 28 Number Analyzed 14 participants 14 participants 14 participants 22 participants
-243.0  (500.49) -15.4  (502.80) -162.7  (558.96) -341.3  (599.52)
100% Gastric Emptying Time(Truncated) Day 1 Number Analyzed 16 participants 15 participants 16 participants 22 participants
2.7  (27.95) 3.7  (28.87) -15.8  (61.32) -65.5  (91.11)
100% Gastric Emptying Time(Truncated) Day 28 Number Analyzed 14 participants 14 participants 14 participants 22 participants
-10.7  (18.60) 19.7  (42.47) -13.9  (42.34) -40.2  (68.66)
Colonic Transit Time Day 1 Number Analyzed 16 participants 14 participants 15 participants 21 participants
-331.3  (1349.11) -92.9  (1970.38) -170.5  (1723.01) -598.3  (1617.05)
Colonic Transit Time Day 28 Number Analyzed 14 participants 12 participants 14 participants 21 participants
-518.1  (2650.06) 142.9  (1326.20) -29.4  (1702.69) -416.4  (1447.79)
Small Bowel Transit Time Day 1 Number Analyzed 16 participants 14 participants 15 participants 21 participants
-24.5  (118.39) -47.7  (94.33) 15.7  (211.88) -6.6  (149.11)
Small Bowel Transit Time 28 Number Analyzed 14 participants 12 participants 14 participants 21 participants
-76.4  (107.89) -57.3  (176.42) -7.1  (148.51) -28.6  (135.44)
Whole Bowel Transit Time Day 1 Number Analyzed 16 participants 14 participants 15 participants 21 participants
-527.6  (1489.02) -402.1  (2109.06) -493.1  (1987.51) -1002.5  (2045.60)
Whole Bowel Transit Time 28 Number Analyzed 16 participants 12 participants 15 participants 21 participants
-777.6  (2644.80) -2.4  (1298.37) -233.5  (1850.91) -789.1  (1560.06)
Time Frame Up to follow-up i.e., 14 days ± 2 days post last dose (Day 28)
Adverse Event Reporting Description All Subjects population was used to assess adverse events.
 
Arm/Group Title Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Hide Arm/Group Description Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days.
All-Cause Mortality
Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/18 (0.00%)      0/18 (0.00%)      0/22 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      0/18 (0.00%)      1/18 (5.56%)      0/22 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer recurrent  1  0/21 (0.00%)  0/18 (0.00%)  1/18 (5.56%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumothorax  1  1/21 (4.76%)  0/18 (0.00%)  0/18 (0.00%)  0/22 (0.00%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo GSK962040 10 mg GSK962040 50 mg GSK962040 125 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/21 (52.38%)      14/18 (77.78%)      14/18 (77.78%)      14/22 (63.64%)    
Blood and lymphatic system disorders         
Anaemia  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Leukocytosis  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Eye disorders         
Ocular hyperaemia  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea  1  1/21 (4.76%)  3 4/18 (22.22%)  5 3/18 (16.67%)  4 3/22 (13.64%)  3
Nausea  1  1/21 (4.76%)  1 4/18 (22.22%)  4 2/18 (11.11%)  2 4/22 (18.18%)  6
Vomiting  1  2/21 (9.52%)  2 2/18 (11.11%)  3 2/18 (11.11%)  2 0/22 (0.00%)  0
Gastrooesophageal reflux disease  1  1/21 (4.76%)  1 1/18 (5.56%)  2 2/18 (11.11%)  2 1/22 (4.55%)  2
Abdominal distension  1  1/21 (4.76%)  2 3/18 (16.67%)  4 0/18 (0.00%)  0 0/22 (0.00%)  0
Abdominal pain upper  1  1/21 (4.76%)  1 1/18 (5.56%)  1 1/18 (5.56%)  2 1/22 (4.55%)  1
Constipation  1  1/21 (4.76%)  1 0/18 (0.00%)  0 2/18 (11.11%)  3 1/22 (4.55%)  2
Abdominal pain  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 1/22 (4.55%)  1
Flatulence  1  0/21 (0.00%)  0 2/18 (11.11%)  2 0/18 (0.00%)  0 0/22 (0.00%)  0
Eructation  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Gastrointestinal pain  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Gastrointestinal sounds abnormal  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Impaired gastric emptying  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Painful defaecation  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
General disorders         
Fatigue  1  2/21 (9.52%)  3 0/18 (0.00%)  0 1/18 (5.56%)  1 2/22 (9.09%)  4
Oedema peripheral  1  0/21 (0.00%)  0 1/18 (5.56%)  1 2/18 (11.11%)  2 0/22 (0.00%)  0
Feeling of body temperature change  1  1/21 (4.76%)  1 0/18 (0.00%)  0 1/18 (5.56%)  2 0/22 (0.00%)  0
Chest pain  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Energy increased  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Infections and infestations         
Urinary tract infection  1  0/21 (0.00%)  0 1/18 (5.56%)  1 2/18 (11.11%)  2 0/22 (0.00%)  0
Upper respiratory tract infection  1  0/21 (0.00%)  0 2/18 (11.11%)  2 0/18 (0.00%)  0 0/22 (0.00%)  0
Cellulitis  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Gastroenteritis  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Hordeolum  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Oral herpes  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Investigations         
Blood glucose decreased  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Weight increased  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Metabolism and nutrition disorders         
Increased appetite  1  0/21 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 1/22 (4.55%)  1
Hypoglycaemia  1  0/21 (0.00%)  0 1/18 (5.56%)  3 0/18 (0.00%)  0 1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  1/21 (4.76%)  1 0/18 (0.00%)  0 1/18 (5.56%)  2 0/22 (0.00%)  0
Chondromalacia  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Nervous system disorders         
Headache  1  4/21 (19.05%)  5 2/18 (11.11%)  3 4/18 (22.22%)  6 6/22 (27.27%)  9
Dizziness  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 3/22 (13.64%)  3
Migraine  1  0/21 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1 1/22 (4.55%)  1
Disturbance in attention  1  0/21 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2 0/22 (0.00%)  0
Memory impairment  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Neuralgia  1  0/21 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0 0/22 (0.00%)  0
Psychiatric disorders         
Anxiety  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Renal and urinary disorders         
Pollakiuria  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders         
Asthma  1  2/21 (9.52%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0 0/22 (0.00%)  0
Sinus congestion  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders         
Night sweats  1  0/21 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1 0/22 (0.00%)  0
1
Term from vocabulary, MedDRA
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01262898     History of Changes
Other Study ID Numbers: 114479
First Submitted: December 16, 2010
First Posted: December 17, 2010
Results First Submitted: September 14, 2017
Results First Posted: October 13, 2017
Last Update Posted: November 17, 2017