| Primary | Gastric Half Emptying Time (GEt1/2) | 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. | 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. | Posted | | Mean | Standard Deviation | Minutes | | Screening2/Baseline (Day -30 to -1) , Day 1, and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. |
| | Units | Counts |
|---|
| Participants | - OG00021
- OG00118
- OG00218
- OG003
|
| | Title | Denominators | Categories |
|---|
| Baseline | - ParticipantsOG00021
- ParticipantsOG00118
- ParticipantsOG00218
- ParticipantsOG003
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| GSK962040 10 mg versus Placebo Day 1 | | | | | Mean Difference (Net) | -3.36 | Standard Deviation | 14.47 | 2-Sided | 95 | -21.96 | 15.24 | | | 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. | | Superiority or Other (legacy) | | | |
|
| Secondary | Number of Participants With On-treatment Adverse Events (AES) and Serious Adverse Events(SAEs) | 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. | | Posted | | Number | | Participants | | Up to follow-up (5-10 days post last dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. |
|
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure(DBP) at Specified Time Points in Semi-supine Position | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Baseline, Day 1, and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg |
|
| Secondary | Change From Baseline in Heart Rate at Specified Time Points in Semi-supine Position | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Beats per minute (BPM) | | Baseline, Day 1, and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | |
|
| Secondary | Change From Baseline in Electrocardiography Parameters (12-lead ECG) | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Milliseconds (msec) | | Baseline, Day 1 and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. |
|
| Secondary | Number of Participants Outside the Normal Range for SBP and DBP | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Number | | Participants | | Screening2/Baseline (Day -30 to -1), Day 1 and 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg |
|
| Secondary | Number of Participants Outside the Normal Range for Heart Rate | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Number | | Participants | | Screening2/Baseline (Day -30 to -1), Day 1 and 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | |
|
| Secondary | Number of Participants Outside the Normal Range for 12-lead ECG | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Number | | Participants | | Baseline (Day 1 pre-dose), Day 1, Day 14 and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 |
|
| Secondary | Mean Change From Baseline in Clinical Chemistry: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Gamma Glutamyl Transferase, Creatine Kinase, Lactate Dehydrogenase | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | International units per liter (IU/L) | | Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. |
|
| Secondary | Mean Change From Baseline in Clinical Chemistry: Direct Bilirubin, Total Bilirubin, Creatinine, Uric Acid | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Unit moles per litre (UMOL/L) | | Baseline (Day 1 pre-dose), Day 5, 10, 14, 21 and 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg |
|
| Secondary | Mean Change From Baseline in Clinical Chemistry : Albumin, Total Protein | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Grams per liter (g/L) | | Baseline (Day 1 pre-dose) and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | |
|
| Secondary | Mean Change From Baseline in Clinical Chemistry : Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN, Carbon Dioxide Content/Bicarbonate | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Millimoles per liter (MMOL/L) | | Baseline (Day 1 pre-dose) and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 |
|
| Secondary | 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 | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Giga (10^9) cells per liter (GI/L) | | Baseline (Day 1 pre-dose) and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. |
|
| Secondary | Mean Change From Baseline in Hematology Parameters : Hematocrit | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Ratio | | Baseline (Day 1 pre-dose) and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. |
|
| Secondary | Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Hemoglobin | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Picograms (Pg) | | Baseline (Day 1 pre-dose) and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | |
|
| Secondary | Mean Change From Baseline in Hematology Parameters : Hemoglobin, Mean Corpuscle Hemoglobin Concentration | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | g/L | | Baseline (Day 1 pre-dose) and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | |
|
| Secondary | Mean Change From Baseline in Hematology Parameters : Mean Corpuscle Volume | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Femtoliters (FL) | | Baseline (Day 1 pre-dose) and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | |
|
| Secondary | Mean Change From Baseline in Hematology Parameters : Red Blood Cell Count, Reticulocytes | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Tera (10^12) cells per liter (TI/L) | | Baseline (Day 1 pre-dose) and Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | |
|
| Secondary | Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration AUC(0-t) at Specified Time Points | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms.hour/milliliter (ng.h/mL) | | Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 | | | | ID | Title | Description |
|---|
| OG000 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 125 mg | Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. |
|
| Secondary | Maximum Observed Concentration (Cmax) at Specified Time Points | 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. | PK population. Only those participants available at specified time points were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | | Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 | | | | ID | Title | Description |
|---|
| OG000 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 125 mg | Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. |
| |
| Secondary | Time of Occurrence of Cmax (Tmax) at Specified Time Points | 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. | PK population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Hour | | Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 | | | | ID | Title | Description |
|---|
| OG000 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 125 mg | Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. |
| |
| Secondary | Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ct) at Specified Time Points | 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. | | Posted | | Mean | Standard Deviation | Liters | | Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 | | | | ID | Title | Description |
|---|
| OG000 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 125 mg | Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. |
| |
| Secondary | Apparent Clearance Following Oral Dosing (CL/F) at Specified Time Points | 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. | PK Population. The data for this outcome measure was not collected. | Posted | | | | | | Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 | | | | ID | Title | Description |
|---|
| OG000 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 125 mg | Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. |
| |
| Secondary | Apparent Volume of Distribution (V/F) at Specified Time Points | 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. | PK Population. The data for this outcome measure was not collected. | Posted | | | | | | Pre-dose and 1.5, 2.5, 3.5, 4.5, and 5.5 hours post dose on Day 1 and 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. |
|
| Secondary | Apparent Terminal Elimination Half-life (t1/2) at Specified Time Points | This outcome measure was not analyzed in results. | PK Population. The data for this outcome measure was not collected. | Posted | | | | | | 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. | | | | ID | Title | Description |
|---|
| OG000 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 125 mg | Participants received GSK962040 125 mg tablets administered orally once daily for a period of 28 days. |
| |
| Secondary | Time to First Bowel Movement After First Dose | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | hours | | Up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | |
|
| Secondary | Daily Bowel Movement Frequency | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Bowel movements/24 hours | | Up to Week 4 (Day 28) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | |
|
| Secondary | Daily Average Stool Consistency | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Bowel Movements/ 24 hours | | Up to Week 4 (Day 28) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. | | OG002 | GSK962040 50 mg | Participants received GSK962040 50 mg tablets administered orally once daily for a period of 28 days. | | OG003 | GSK962040 125 mg | |
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| Secondary | Change From Baseline in Upper Gastrointestinal (GI) Symptoms as Assessed by Total Gastrointestinal Cardinal Symptom Index - Daily Diary (GCSI-DD) | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | Score on a scale | | Up to 14 days post last dose (Day 28) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. |
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| Secondary | 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) | 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. | All Subjects Population. Only those participants available at specified time points were analyzed. | Posted | | Mean | Standard Deviation | minutes | | Baseline(Screening i.e., Day -30 to -1), Day 1 and 28 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo tablets matching to GSK962040 administered orally once daily for a period of 28 days. | | OG001 | GSK962040 10 mg | Participants received GSK962040 10 mg tablets administered orally once daily for a period of 28 days. |
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