| Primary | Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline | Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. AUC is a measure of levodopa exposure. | Pharmacodynamic (PD)/Efficacy Population: participants receiving >=1 dose placebo/GSK962040 50 mg. Only those participants available at the specified time point were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour/milliliter/milligram | | Baseline | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00024.13± 37.5
- OG00124.81± 36.1
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| Primary | Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios (GSK962040 50 mg: Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa pharmacokinetic (PK) parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect. AUC is a measure of levodopa exposure | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Least Squares Mean | Standard Error | Nanograms*hour/milliliter/milligram | | Day 1 and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Primary | Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline | Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data. | PD/Efficacy Population. Only those participants available at the specified time point were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms/milliliter/milligram | | Baseline | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Primary | Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Least Squares Mean | Standard Error | Nanograms/milliliter/milligram | | Day 1 and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Primary | L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | L-DOPA Tmax was derived from L-DOPA plasma concentration-time data. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Median | Full Range | Hours | | Baseline, Day 1, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Primary | L-DOPA Terminal Phase Half-life (t1/2) at Baseline, Day 1, and Day 8 | L-DOPA t1/2 was derived from L-DOPA plasma concentration-time data. This endpoint was not assessed because there were insufficient L-DOPA data/profiles to calculate this parameter. | | Posted | | | | | | Baseline, Day 1, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | 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 8, 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 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. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Minutes | | Baseline, Day 1, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline, Day 1, and Day 8 at pre-levodopa dose | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Scores at Baseline, Day 1, and Day 8 (Pre-dose; 120, 180, and 240 Minutes Post-dose) | The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline, Day 1, and Day 8 at pre-dose and 120, 180, and 240 minutes (min) post-dose (PD); Follow-up visit (up to Day 25) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Period Mean Amount of Hours Spent "ON," "ON" Without Dyskinesia, "ON" With Non-troublesome Dyskinesia, "ON" With Troublesome Dyskinesia, and "OFF" at Baseline and During the Treatment Period (Days 1-8), Week 1 of Follow-up, and Week 2 of Follow-up | Participants were provided with the "ON/OFF" diary to capture details of the amount of awake time spent on/off of PD symptoms, and were asked to complete the diary daily. Participants checked the box most appropriate for their dominant motor state in the preceding 30-minute period. The catergories included: "ON" (including "ON without dyskinesia" and "ON with non-troublesome dyskinesia"), "ON" with troublesome dyskinesia (TD), and "OFF." For Baseline, data were collected for 2 days prior to Day 1, and the mean value of the 2 days was used. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | hours | | Baseline, Days 1-8, Week 1 of Follow-up (Days 6 and 7 of Follow-up; up to Day 16), and Week 2 of Follow-up (Days 13 and 14 of Follow-up; up to Day 23) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Number of Times a Participant Could Alternatively Tap Two Counter Keys 30 Centimeters Apart in 1 Minute (Min) at Baseline, Day1, Day 8, and Follow-up | Participants were asked to alternatively tap two keys 30 centimeters apart in 1 minute in two trials with the most affected hand or the dominant hand in symmetric disease. The finger tapping was scored manually by the study staff. The finger-tapping assessment was repeated at eight separate time points (pre-dose, 0 min, 30 min, 60 min, 90 min, 120 min, 180 min, and 240 min post-dose) at each visit (Baseline, Day 1, and Day 8). At each time point, the mean of the two assessments was calculated. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Finger taps per minute | | Baseline, Day 1, and Day 8 at pre-dose and 0, 30, 60, 90, 120, 180, and 240 minutes post-dose; Follow-up visit (up to Day 25) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Various formulations of L-DOPA were utilized by participants for the treatment of Parkinson's Disease. The total daily L-DOPA equivalent dose was calculated as the sum of all L-DOPA equivalent doses for each L-DOPA-containing drug taken on the same day. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Milligrams | | Baseline and Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | Blood pressure measurements were taken at pre-dose and at 0 min (completion of meal) on Day 1 and Day 8. 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 (ASP): all participants who received >=1 dose of study medication. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Millimeters of mercury | | Baseline, Day 1, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Heart Rate at Day 1 and Day 8 | Heart rate measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline, Day 1, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. ECG findings were categorized as normal, abnormal - not clinically significant, and abnormal - clinically significant (CS), based on interpretation by the site. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Number | | Participants | | Day 1 and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | ALB and TP measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline, Day 4, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) at Day 4 and Day 8 | ALP, ALT, AST, and GGT measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | International units per liter | | Baseline, Day 4, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Calcium, Chloride, Carbon Dioxide Content (CO2)/Bicarbonate (BC), Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN), and Uric Acid (UA) at Day 4 and Day 8 | Calcium, chloride, CO2/BC, glucose, potassium, sodium, urea/BUN, and UA measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline, Day 4, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Basophils, eosinophils, lymphocytes, monocytes, total ANC, and PC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Giga (10^9) cells per liter | | Baseline, Day 4, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | Hemoglobin and MCHC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline, Day 4, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Hematocrit at Day 4 and Day 8 | Hematocrit measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | proportion of 1 | | Baseline, Day 4, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8 | MCH measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Picograms | | Baseline, Day 4, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8 | MCV measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Femtoliters | | Baseline, Day 4, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | RBC and WBC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Giga (10^9) cells per liter | | Baseline, Day 4, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8 | RET measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. 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. | ASP. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Mean | Standard Deviation | Tera (10^12) cells per liter | | Baseline, Day 4, and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect, is associated with liver injury and impaired liver function, or are serious events as per the medical or scientific judgment. | | Posted | | Number | | Participants | | From the start of study medication until Follow-up (up to Day 25) | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. | | OG002 | GSK962040 Total | Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days. |
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| Secondary | GSK962040 Area Under the Plasma Concentration-time Curve From Zero to 5.5 Hours (AUC[0-5.5] and Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC[0-inf]) at Days 1 and 8 | GSK AUC(0-5.5) and AUC(0-inf) were derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed. AUC is a measure of levodopa exposure. Data for AUC(0-inf) was analyzed and was only available for Day 1 and not for Day 8. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms.hour/milliliter | | Day 1 and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Secondary | GSK962040 Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) at Day 1 | GSK962040 %AUCex was derived from GSK962040 plasma concentration-time data. %AUCex is the percentage of the AUC(0-inf) extrapolated from the last PK sample drawn to infinity. This parameter is only reported in conjunction with single-dose AUC(0-inf). Only participants who received GSK962040 50 mg were analyzed. AUC is a measure of levodopa exposure. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Percentage | | Day 1 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Secondary | GSK962040 Cmax at Day1 and Day 8 | GSK962040 Cmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Nanograms/milliliter | | Day 1 and Day 8 | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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| Secondary | GSK962040 Tmax at Day1 and Day 8 | GSK962040 tmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed. | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Posted | | Median | Full Range | Hours | | Day 1 and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo administered orally once daily for 7 to 9 days. | | OG001 | GSK962040 50 mg | Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days. |
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