Gastroparesis
Conditions
Brief summary
Gastric emptying is the end-result of a complex and carefully regulated series of events which follow the ingestion of a meal, each of which is dependent on the other and subject to neurohormonal control. Motilin is an endogenous peptide, produced mainly in the duodenum, whose physiological action is mediated by motilin receptors located on enteric neurons, peripheral terminals of the vagus, and on the smooth muscle of the gut. Motilin and non-peptide agonists at motilin receptors increases the gastric emptying rate and therefore provide a potential approach to the treatment of a range of clinical conditions in which delayed gastric emptying is thought to be part of the physiopathology and may be contributory to symptoms. Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by degeneration of nigrostriatal dopaminergic neurones. It affects 1.5% of the global population over 65 years of age. Cardinal symptoms comprise bradykinesia, rigidity, resting tremors and postural instability. Gastrointestinal dysfunction, including gastroparesis, is a frequent feature of PD affecting approximately 90% of patients, and is caused by autonomic dysfunction as well as an adverse effect of antiparkinsonian drug therapy. The therapeutic mainstay for PD treatment is the neutral amino acid L-3,4-dihydroxyphenylalanine (L-DOPA), a dopamine prodrug, as it provides the most rapid and effective symptomatic control of motor impairment in PD. The primary determinant of L-DOPA bioavailability is gastric emptying (GE); delays in GE slow delivery of L-DOPA to its proximal small intestinal absorption sites, increasing the extent of presystemic metabolism, and leading to slowed and diminished absorption.
Detailed description
MOT115816 will be conducted as a multi-center, randomized, double-blind, placebo controlled study to investigate the ability of the motilin receptor agonist GSK962040 to improve L-DOPA pharmacokinetics (PK) by enhancing gastric emptying via motilin receptor agonism. Subjects will be randomized to receive 50 mg GSK962040 or placebo in a 2:1 ratio administered orally once daily for 7-9 days. The study will consist of a screening/baseline period, a treatment period, and a 14-day post treatment safety follow-up visit. During this period participants will be asked to attend the study center for 5 visits 3 of which will last approximately 5 hours. The duration of each patient's participation in the study from screening to follow-up visit will be approximately 7-8 weeks. For three of the visits, subjects will visit the clinical unit fasted and prior to taking their first morning L-DOPA dose. Volunteers will undergo a complete physical (including cardiovascular monitoring (ECG), vital signs, blood samples, and medical history), measurement of plasma L-DOPA levels, completion of patient diary to capture the amount of awake time (in hours) spent on without dyskinesias, on with troublesome dyskinesias, on with non-troublesome dyskinesias, and off and gastric symptoms, non-motor and motor symptoms assessments (MDS-UPDRS rating scale and finger taps) and measurement of gastric emptying rate.
Interventions
25 mg tablet
DRUGPlacebo
matching placebo tablet
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic Parkinson's Disease (according to modified Hoehn & Yahr criteria Stages II-IV) and with suboptimal motor control on L-DOPA or L-DOPA combination therapy (i.e. wearing off, peak dose dyskinesias, delayed on or no-on effects) * Subjects receiving a stable regimen of L-DOPA for at least four weeks prior to screening * Patient has gastric half-time of emptying \> or = 70 min as determined by 13C oral breath test * Between 40 and 80 years of age, inclusive. * Patient has never had a gastrectomy, nor major gastric surgical procedure or any evidence of bowel obstruction or strictures within the previous 12 months * Dosage of any concomitant medications has been stable for at least 4 weeks * A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<147 pmol/L) is confirmatory\]. Child-bearing potential and is abstinent or agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until at least 5 days post-last dose. * ALT \< 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Single or Average QTc, QTcB or QTcF\< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.
Exclusion criteria
* Late stage advanced subjects with incapacitating peak dose or biphasic dyskinesia ona stable L-DOPA regime. * Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, neurological (other than Parkinson's disease), gastro-intestinal, hematological, endocrinologic, neurological (other than Parkinson's disease), cardiovascular disease, active malignancy (other than basal cell cancer) or other condition that would in the opinion of the investigator or medical monitor make the subject unsuitable for inclusion in this clinical study. * A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening * Patient has a gastric pacemaker * Patient is on chronic enteral (e.g., feeding tube) or parenteral feeding * Patient has evidence of severe cardiovascular autonomic neuropathy (e.g. history of recurrent syncope in the last 6 months) * Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing. * Lactating females. * Unable to refrain from consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until followup. * Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g., prokinetic drugs, macrolide antibiotics (erythromycin), GLP-1 mimetics) * Unable to refrain from use of prohibited medications listed in Section 9 within the restricted timeframe relative to the first dose of study medication. * The patient has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. * Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day time-period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline | Baseline | Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. AUC is a measure of levodopa exposure. |
| Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | 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 |
| Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline | Baseline | Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data. |
| Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | 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. |
| L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | Baseline, Day 1, and Day 8 | L-DOPA Tmax was derived from L-DOPA plasma concentration-time data. |
| L-DOPA Terminal Phase Half-life (t1/2) at Baseline, Day 1, and Day 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | Baseline, 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. |
| Change From Baseline in Heart Rate at Day 1 and Day 8 | Baseline, 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. |
| Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | 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. |
| Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | Baseline, 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. |
| 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 | Baseline, 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. |
| 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 | Baseline, 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. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Baseline, 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. |
| Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | Baseline, 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. |
| Change From Baseline in Hematocrit at Day 4 and Day 8 | Baseline, 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. |
| Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | Baseline, 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. |
| Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8 | Baseline, 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. |
| Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | Baseline, 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. |
| Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8 | Baseline, 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. |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | From the start of study medication until Follow-up (up to Day 25) | 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. |
| 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 | Day 1 and Day 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. |
| GSK962040 Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) at Day 1 | 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. |
| GSK962040 Cmax at Day1 and Day 8 | Day 1 and Day 8 | GSK962040 Cmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed. |
| GSK962040 Tmax at Day1 and Day 8 | Day 1 and Day 8 | GSK962040 tmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed. |
| Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8 | Baseline, 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. |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Baseline, Day 1, and Day 8 at 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. |
| 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) | 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) | 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. |
| 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 | 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) | 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. |
| 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 | 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) | 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. |
| Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Baseline and 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. |
Countries
Australia, Germany, Sweden, United Kingdom
Participant flow
Pre-assignment details
The study consisted of a Screening/Baseline Period, a Treatment Period, and a 14-day post-treatment safety Follow-up Visit. Participants were randomized to receive GSK962040 50 milligrams or placebo in a 2:1 ratio; one participant was randomized to receive GSK962040 125 mg.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo administered orally once daily for 7 to 9 days. | 19 |
| 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. | 38 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | GSK962040 Total | Total |
|---|---|---|---|
| Age, Continuous | 66.7 Years STANDARD_DEVIATION 8.04 | 67.4 Years STANDARD_DEVIATION 7.97 | 67.1 Years STANDARD_DEVIATION 7.93 |
| Gender Female | 11 Participants | 9 Participants | 20 Participants |
| Gender Male | 8 Participants | 29 Participants | 37 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 19 Participants | 38 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 19 | 21 / 37 | 1 / 1 |
| serious Total, serious adverse events | 2 / 19 | 2 / 37 | 0 / 1 |
Outcome results
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
Time frame: Day 1 and Day 8
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | Day 1, n=17, 31 | 26.6 Nanograms*hour/milliliter/milligram | Standard Error 0.058 |
| Placebo | Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | Day 8, n=17, 32 | 27.1 Nanograms*hour/milliliter/milligram | Standard Error 0.058 |
| GSK962040 50 mg | Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | Day 1, n=17, 31 | 25.7 Nanograms*hour/milliliter/milligram | Standard Error 0.047 |
| GSK962040 50 mg | Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | Day 8, n=17, 32 | 24.1 Nanograms*hour/milliliter/milligram | Standard Error 0.047 |
Comparison: GSK962040 50 mg : Placebo Day 195% CI: [0.831, 1.12]
Comparison: GSK962040 50 mg : Placebo Day 895% CI: [0.763, 1.029]
Comparison: Day 8: Day 195% CI: [0.85, 1.033]
Comparison: Day 8:Day 1 Placebo95% CI: [0.89, 1.17]
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.
Time frame: Day 1 and Day 8
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | Day 1, n=18, 35 | 13.4 Nanograms/milliliter/milligram | Standard Error 0.081 |
| Placebo | Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | Day 8, n=17, 35 | 11.6 Nanograms/milliliter/milligram | Standard Error 0.083 |
| GSK962040 50 mg | Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | Day 1, n=18, 35 | 11.6 Nanograms/milliliter/milligram | Standard Error 0.065 |
| GSK962040 50 mg | Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | Day 8, n=17, 35 | 11.8 Nanograms/milliliter/milligram | Standard Error 0.065 |
Comparison: GSK962040 50 mg Vs Placebo Day 195% CI: [0.702, 1.064]
Comparison: GSK962040 50 mg Vs Placebo Day 895% CI: [0.824, 1.257]
Comparison: Day 8 VS Day 1 GSK962040 50 mg95% CI: [0.889, 1.166]
Comparison: Day 8 Vs Day 1 Placebo95% CI: [0.709, 1.055]
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.
Time frame: Baseline
Population: PD/Efficacy Population. Only those participants available at the specified time point were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline | 12.77 Nanograms/milliliter/milligram | Geometric Coefficient of Variation 28 |
| GSK962040 50 mg | Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline | 12.89 Nanograms/milliliter/milligram | Geometric Coefficient of Variation 42.6 |
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.
Time frame: Baseline
Population: Pharmacodynamic (PD)/Efficacy Population: participants receiving \>=1 dose placebo/GSK962040 50 mg. Only those participants available at the specified time point were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline | 24.13 Nanograms*hour/milliliter/milligram | Geometric Coefficient of Variation 37.5 |
| GSK962040 50 mg | Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline | 24.81 Nanograms*hour/milliliter/milligram | Geometric Coefficient of Variation 36.1 |
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.
Time frame: Baseline, Day 1, and Day 8
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.
Time frame: Baseline, Day 1, and Day 8
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | Day 1, n=18, 35 | 1.61 Hours |
| Placebo | L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | Day 8, n=17, 35 | 2.00 Hours |
| Placebo | L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | Baseline, n=17, 35 | 1.50 Hours |
| GSK962040 50 mg | L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | Baseline, n=17, 35 | 2.00 Hours |
| GSK962040 50 mg | L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | Day 1, n=18, 35 | 1.50 Hours |
| GSK962040 50 mg | L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | Day 8, n=17, 35 | 1.55 Hours |
Comparison: Day 1p-value: 0.157Wilcoxon rank-sum test
Comparison: Day 8p-value: 0.186Wilcoxon rank-sum test
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.
Time frame: Baseline, Day 4, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | TP, Day 4, n=18, 30, 31 | -0.3 Grams per liter | Standard Deviation 3.28 |
| Placebo | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | TP, Day 8, n=15, 31, 32 | -0.0 Grams per liter | Standard Deviation 3.24 |
| Placebo | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | ALB, Day 4, n=18, 34, 35 | 0.06 Grams per liter | Standard Deviation 2.313 |
| Placebo | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | ALB, Day 8, n=18, 34, 35 | 0.11 Grams per liter | Standard Deviation 2.22 |
| GSK962040 50 mg | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | TP, Day 4, n=18, 30, 31 | -0.9 Grams per liter | Standard Deviation 3.93 |
| GSK962040 50 mg | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | TP, Day 8, n=15, 31, 32 | -0.3 Grams per liter | Standard Deviation 3.72 |
| GSK962040 50 mg | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | ALB, Day 8, n=18, 34, 35 | -0.33 Grams per liter | Standard Deviation 2.084 |
| GSK962040 50 mg | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | ALB, Day 4, n=18, 34, 35 | -0.38 Grams per liter | Standard Deviation 2.155 |
| GSK962040 Total | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | TP, Day 8, n=15, 31, 32 | -0.3 Grams per liter | Standard Deviation 3.66 |
| GSK962040 Total | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | ALB, Day 4, n=18, 34, 35 | -0.37 Grams per liter | Standard Deviation 2.124 |
| GSK962040 Total | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | ALB, Day 8, n=18, 34, 35 | -0.29 Grams per liter | Standard Deviation 2.065 |
| GSK962040 Total | Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8 | TP, Day 4, n=18, 30, 31 | -1.0 Grams per liter | Standard Deviation 3.97 |
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.
Time frame: Baseline, Day 4, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | AST, Day 8, n=16, 31, 32 | 0.6 International units per liter | Standard Deviation 4.55 |
| Placebo | 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 | ALT, Day 8, n=18, 34, 35 | -1.6 International units per liter | Standard Deviation 6.88 |
| Placebo | 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 | GGT, Day 4, n=19, 33, 34 | -0.8 International units per liter | Standard Deviation 3.2 |
| Placebo | 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 | ALT, Day 4, n=19, 33, 34 | -6.4 International units per liter | Standard Deviation 10.45 |
| Placebo | 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 | AST, Day 4, n=19, 32, 33 | 0.2 International units per liter | Standard Deviation 3.16 |
| Placebo | 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 | GGT, Day 4, n=18, 33, 34 | -0.1 International units per liter | Standard Deviation 5.22 |
| Placebo | 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, Day 8, n=18, 34, 35 | -0.1 International units per liter | Standard Deviation 7.66 |
| Placebo | 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, Day 4, n=19, 33, 34 | -0.8 International units per liter | Standard Deviation 5.26 |
| GSK962040 50 mg | 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 | AST, Day 4, n=19, 32, 33 | -1.2 International units per liter | Standard Deviation 2.89 |
| GSK962040 50 mg | 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, Day 4, n=19, 33, 34 | 2.4 International units per liter | Standard Deviation 14.14 |
| GSK962040 50 mg | 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 | ALT, Day 8, n=18, 34, 35 | -0.4 International units per liter | Standard Deviation 5.46 |
| GSK962040 50 mg | 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, Day 8, n=18, 34, 35 | 1.4 International units per liter | Standard Deviation 13.35 |
| GSK962040 50 mg | 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 | ALT, Day 4, n=19, 33, 34 | -5.9 International units per liter | Standard Deviation 9.77 |
| GSK962040 50 mg | 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 | AST, Day 8, n=16, 31, 32 | 1.0 International units per liter | Standard Deviation 3.65 |
| GSK962040 50 mg | 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 | GGT, Day 4, n=19, 33, 34 | -0.8 International units per liter | Standard Deviation 3.06 |
| GSK962040 50 mg | 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 | GGT, Day 4, n=18, 33, 34 | -1.0 International units per liter | Standard Deviation 5.02 |
| GSK962040 Total | 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 | GGT, Day 4, n=19, 33, 34 | -0.9 International units per liter | Standard Deviation 3.04 |
| GSK962040 Total | 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 | ALT, Day 8, n=18, 34, 35 | -0.6 International units per liter | Standard Deviation 5.57 |
| GSK962040 Total | 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 | AST, Day 4, n=19, 32, 33 | -1.3 International units per liter | Standard Deviation 2.96 |
| GSK962040 Total | 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 | AST, Day 8, n=16, 31, 32 | 0.9 International units per liter | Standard Deviation 3.63 |
| GSK962040 Total | 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 | ALT, Day 4, n=19, 33, 34 | -7.1 International units per liter | Standard Deviation 11.72 |
| GSK962040 Total | 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 | GGT, Day 4, n=18, 33, 34 | -1.0 International units per liter | Standard Deviation 4.95 |
| GSK962040 Total | 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, Day 4, n=19, 33, 34 | 2.2 International units per liter | Standard Deviation 13.98 |
| GSK962040 Total | 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, Day 8, n=18, 34, 35 | 1.2 International units per liter | Standard Deviation 13.21 |
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.
Time frame: Baseline, Day 4, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Lymphocytes, Day 8, n=17, 35, 36 | -0.049 Giga (10^9) cells per liter | Standard Deviation 0.3258 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Monocytes, Day 8, n=17, 35, 36 | -0.004 Giga (10^9) cells per liter | Standard Deviation 0.086 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Monocytes, Day 4, n=19, 34, 35 | 0.006 Giga (10^9) cells per liter | Standard Deviation 0.1313 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Basophils, Day 4, n=19, 34, 35 | -0.003 Giga (10^9) cells per liter | Standard Deviation 0.02 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Eosinophils, Day 8, n=17, 35, 36 | -0.016 Giga (10^9) cells per liter | Standard Deviation 0.0519 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Eosinophils, Day 4, n=19, 34, 35 | 0.003 Giga (10^9) cells per liter | Standard Deviation 0.1219 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Basophils, Day 8, n=17, 35, 36 | -0.006 Giga (10^9) cells per liter | Standard Deviation 0.0153 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | PC, Day 4, n=19, 34, 35 | 4.5 Giga (10^9) cells per liter | Standard Deviation 18.45 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | PC, Day 8, n=17, 35, 36 | 1.8 Giga (10^9) cells per liter | Standard Deviation 24.42 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Total ANC , Day 8, n=17, 35, 36 | 0.007 Giga (10^9) cells per liter | Standard Deviation 0.8586 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Lymphocytes, Day 4, n=19, 34, 35 | 0.093 Giga (10^9) cells per liter | Standard Deviation 0.4326 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Total ANC , Day 4, n=19, 34, 35 | 0.021 Giga (10^9) cells per liter | Standard Deviation 0.8866 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Lymphocytes, Day 8, n=17, 35, 36 | 0.076 Giga (10^9) cells per liter | Standard Deviation 0.5874 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Basophils, Day 4, n=19, 34, 35 | -0.006 Giga (10^9) cells per liter | Standard Deviation 0.0247 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Basophils, Day 8, n=17, 35, 36 | -0.001 Giga (10^9) cells per liter | Standard Deviation 0.0195 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Eosinophils, Day 4, n=19, 34, 35 | -0.031 Giga (10^9) cells per liter | Standard Deviation 0.0584 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Eosinophils, Day 8, n=17, 35, 36 | -0.001 Giga (10^9) cells per liter | Standard Deviation 0.0466 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Lymphocytes, Day 4, n=19, 34, 35 | 0.044 Giga (10^9) cells per liter | Standard Deviation 0.3592 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Monocytes, Day 4, n=19, 34, 35 | 0.002 Giga (10^9) cells per liter | Standard Deviation 0.0923 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Monocytes, Day 8, n=17, 35, 36 | -0.013 Giga (10^9) cells per liter | Standard Deviation 0.0928 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Total ANC , Day 4, n=19, 34, 35 | 0.392 Giga (10^9) cells per liter | Standard Deviation 0.948 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Total ANC , Day 8, n=17, 35, 36 | -0.114 Giga (10^9) cells per liter | Standard Deviation 0.85 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | PC, Day 4, n=19, 34, 35 | 3.6 Giga (10^9) cells per liter | Standard Deviation 18.76 |
| GSK962040 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | PC, Day 8, n=17, 35, 36 | 1.4 Giga (10^9) cells per liter | Standard Deviation 22.97 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Lymphocytes, Day 4, n=19, 34, 35 | 0.033 Giga (10^9) cells per liter | Standard Deviation 0.3592 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | PC, Day 4, n=19, 34, 35 | 3.3 Giga (10^9) cells per liter | Standard Deviation 18.53 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Total ANC , Day 4, n=19, 34, 35 | 0.406 Giga (10^9) cells per liter | Standard Deviation 0.9377 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Eosinophils, Day 8, n=17, 35, 36 | 0.000 Giga (10^9) cells per liter | Standard Deviation 0.0467 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Basophils, Day 4, n=19, 34, 35 | -0.006 Giga (10^9) cells per liter | Standard Deviation 0.0244 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Total ANC , Day 8, n=17, 35, 36 | -0.122 Giga (10^9) cells per liter | Standard Deviation 0.8392 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Basophils, Day 8, n=17, 35, 36 | -0.001 Giga (10^9) cells per liter | Standard Deviation 0.0192 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Eosinophils, Day 4, n=19, 34, 35 | -0.034 Giga (10^9) cells per liter | Standard Deviation 0.0599 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Monocytes, Day 4, n=19, 34, 35 | 0.004 Giga (10^9) cells per liter | Standard Deviation 0.0913 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Lymphocytes, Day 8, n=17, 35, 36 | 0.073 Giga (10^9) cells per liter | Standard Deviation 0.5793 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | PC, Day 8, n=17, 35, 36 | 0.7 Giga (10^9) cells per liter | Standard Deviation 22.97 |
| GSK962040 Total | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8 | Monocytes, Day 8, n=17, 35, 36 | -0.013 Giga (10^9) cells per liter | Standard Deviation 0.0916 |
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.
Time frame: Baseline, Day 4, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Potassium, Day 4, n=19, 32, 33 | 0.008 Millimoles per liter | Standard Deviation 0.3393 |
| Placebo | 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 | Glucose, Day 4, n=19, 35, 36 | 1.14 Millimoles per liter | Standard Deviation 2.944 |
| Placebo | 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 | Urea/BUN, Day 8, n=17, 34, 35 | -0.63 Millimoles per liter | Standard Deviation 1.318 |
| Placebo | 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 | CO2/BC, Day 8, n=8, 22, 23 | 0.51 Millimoles per liter | Standard Deviation 2.053 |
| Placebo | 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 | Chloride, Day 8, n=18, 33, 34 | 0.39 Millimoles per liter | Standard Deviation 2.57 |
| Placebo | 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 | UA, Day 8, n=14, 29, 30 | -1.56 Millimoles per liter | Standard Deviation 22.601 |
| Placebo | 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, Day 8, n=18, 35, 36 | 0.026 Millimoles per liter | Standard Deviation 0.0756 |
| Placebo | 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 | CO2/BC, Day 4, n=9, 21, 22 | -0.06 Millimoles per liter | Standard Deviation 2.833 |
| Placebo | 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 | Urea/BUN, Day 4, n=17, 32, 33 | -0.27 Millimoles per liter | Standard Deviation 1.757 |
| Placebo | 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 | Chloride, Day 4, n=19, 33, 34 | -1.37 Millimoles per liter | Standard Deviation 1.832 |
| Placebo | 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 | Potassium, Day 8, n=16, 31, 32 | 0.055 Millimoles per liter | Standard Deviation 0.3405 |
| Placebo | 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 | Glucose, Day 8, n=18, 36, 36 | -0.03 Millimoles per liter | Standard Deviation 0.865 |
| Placebo | 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, Day 4, n=19, 34, 35 | 0.010 Millimoles per liter | Standard Deviation 0.0746 |
| Placebo | 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 | Sodium, Day 4, n=19, 34, 35 | -0.89 Millimoles per liter | Standard Deviation 2.787 |
| Placebo | 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 | Sodium, Day 8, n=18, 34, 35 | 1.39 Millimoles per liter | Standard Deviation 3.202 |
| Placebo | 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 | UA, Day 4, n=16, 30, 31 | -14.22 Millimoles per liter | Standard Deviation 23.416 |
| GSK962040 50 mg | 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 | Glucose, Day 8, n=18, 36, 36 | 0.09 Millimoles per liter | Standard Deviation 0.594 |
| GSK962040 50 mg | 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, Day 4, n=19, 34, 35 | -0.009 Millimoles per liter | Standard Deviation 0.0659 |
| GSK962040 50 mg | 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, Day 8, n=18, 35, 36 | -0.018 Millimoles per liter | Standard Deviation 0.0662 |
| GSK962040 50 mg | 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 | Chloride, Day 4, n=19, 33, 34 | -0.42 Millimoles per liter | Standard Deviation 2.346 |
| GSK962040 50 mg | 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 | CO2/BC, Day 4, n=9, 21, 22 | 0.16 Millimoles per liter | Standard Deviation 2.602 |
| GSK962040 50 mg | 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 | Glucose, Day 4, n=19, 35, 36 | 0.14 Millimoles per liter | Standard Deviation 1.198 |
| GSK962040 50 mg | 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 | Sodium, Day 8, n=18, 34, 35 | 0.21 Millimoles per liter | Standard Deviation 1.647 |
| GSK962040 50 mg | 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 | Chloride, Day 8, n=18, 33, 34 | 0.52 Millimoles per liter | Standard Deviation 1.734 |
| GSK962040 50 mg | 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 | CO2/BC, Day 8, n=8, 22, 23 | 0.23 Millimoles per liter | Standard Deviation 2.139 |
| GSK962040 50 mg | 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 | Potassium, Day 4, n=19, 32, 33 | 0.168 Millimoles per liter | Standard Deviation 0.3408 |
| GSK962040 50 mg | 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 | Potassium, Day 8, n=16, 31, 32 | 0.048 Millimoles per liter | Standard Deviation 0.2897 |
| GSK962040 50 mg | 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 | Sodium, Day 4, n=19, 34, 35 | -0.56 Millimoles per liter | Standard Deviation 1.779 |
| GSK962040 50 mg | 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 | Urea/BUN, Day 4, n=17, 32, 33 | 0.00 Millimoles per liter | Standard Deviation 1.496 |
| GSK962040 50 mg | 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 | Urea/BUN, Day 8, n=17, 34, 35 | 0.13 Millimoles per liter | Standard Deviation 1.308 |
| GSK962040 50 mg | 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 | UA, Day 4, n=16, 30, 31 | 0.53 Millimoles per liter | Standard Deviation 29.735 |
| GSK962040 50 mg | 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 | UA, Day 8, n=14, 29, 30 | 6.39 Millimoles per liter | Standard Deviation 30.819 |
| GSK962040 Total | 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 | Glucose, Day 8, n=18, 36, 36 | -0.09 Millimoles per liter | Standard Deviation 0.594 |
| GSK962040 Total | 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 | Sodium, Day 8, n=18, 34, 35 | 0.29 Millimoles per liter | Standard Deviation 1.69 |
| GSK962040 Total | 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, Day 8, n=18, 35, 36 | -0.017 Millimoles per liter | Standard Deviation 0.0652 |
| GSK962040 Total | 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 | Potassium, Day 4, n=19, 32, 33 | 0.151 Millimoles per liter | Standard Deviation 0.3497 |
| GSK962040 Total | 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 | Glucose, Day 4, n=19, 35, 36 | 0.15 Millimoles per liter | Standard Deviation 1.185 |
| GSK962040 Total | 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, Day 4, n=19, 34, 35 | -0.011 Millimoles per liter | Standard Deviation 0.0667 |
| GSK962040 Total | 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 | Potassium, Day 8, n=16, 31, 32 | 0.043 Millimoles per liter | Standard Deviation 0.2862 |
| GSK962040 Total | 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 | Chloride, Day 4, n=19, 33, 34 | -0.41 Millimoles per liter | Standard Deviation 2.311 |
| GSK962040 Total | 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 | UA, Day 4, n=16, 30, 31 | -0.78 Millimoles per liter | Standard Deviation 30.127 |
| GSK962040 Total | 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 | UA, Day 8, n=14, 29, 30 | 6.17 Millimoles per liter | Standard Deviation 30.306 |
| GSK962040 Total | 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 | Chloride, Day 8, n=18, 33, 34 | 0.53 Millimoles per liter | Standard Deviation 1.71 |
| GSK962040 Total | 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 | CO2/BC, Day 4, n=9, 21, 22 | 0.20 Millimoles per liter | Standard Deviation 2.546 |
| GSK962040 Total | 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 | Urea/BUN, Day 8, n=17, 34, 35 | 0.14 Millimoles per liter | Standard Deviation 1.289 |
| GSK962040 Total | 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 | Sodium, Day 4, n=19, 34, 35 | -0.51 Millimoles per liter | Standard Deviation 1.772 |
| GSK962040 Total | 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 | CO2/BC, Day 8, n=8, 22, 23 | 0.13 Millimoles per liter | Standard Deviation 2.141 |
| GSK962040 Total | 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 | Urea/BUN, Day 4, n=17, 32, 33 | -0.02 Millimoles per liter | Standard Deviation 1.477 |
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.
Time frame: Baseline, Day 1, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Heart Rate at Day 1 and Day 8 | Day 8: 0 min, n=18, 36, 37 | -2.5 Beats per minute | Standard Deviation 7.64 |
| Placebo | Change From Baseline in Heart Rate at Day 1 and Day 8 | Day 8: pre-dose, n=18, 36, 37 | -2.9 Beats per minute | Standard Deviation 7.67 |
| Placebo | Change From Baseline in Heart Rate at Day 1 and Day 8 | Day 1: 0 min, n=19, 37, 38 | -2.2 Beats per minute | Standard Deviation 7.3 |
| GSK962040 50 mg | Change From Baseline in Heart Rate at Day 1 and Day 8 | Day 8: 0 min, n=18, 36, 37 | -0.5 Beats per minute | Standard Deviation 6.8 |
| GSK962040 50 mg | Change From Baseline in Heart Rate at Day 1 and Day 8 | Day 1: 0 min, n=19, 37, 38 | 0.8 Beats per minute | Standard Deviation 9.19 |
| GSK962040 50 mg | Change From Baseline in Heart Rate at Day 1 and Day 8 | Day 8: pre-dose, n=18, 36, 37 | 0.6 Beats per minute | Standard Deviation 6.12 |
| GSK962040 Total | Change From Baseline in Heart Rate at Day 1 and Day 8 | Day 8: pre-dose, n=18, 36, 37 | 0.0 Beats per minute | Standard Deviation 6.84 |
| GSK962040 Total | Change From Baseline in Heart Rate at Day 1 and Day 8 | Day 1: 0 min, n=19, 37, 38 | 0.5 Beats per minute | Standard Deviation 9.26 |
| GSK962040 Total | Change From Baseline in Heart Rate at Day 1 and Day 8 | Day 8: 0 min, n=18, 36, 37 | -0.5 Beats per minute | Standard Deviation 6.71 |
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.
Time frame: Baseline, Day 4, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematocrit at Day 4 and Day 8 | Day 8, n=17, 35, 36 | -0.0044 proportion of 1 | Standard Deviation 0.01383 |
| Placebo | Change From Baseline in Hematocrit at Day 4 and Day 8 | Day 4, n=19, 34, 35 | -0.0059 proportion of 1 | Standard Deviation 0.02331 |
| GSK962040 50 mg | Change From Baseline in Hematocrit at Day 4 and Day 8 | Day 8, n=17, 35, 36 | -0.0037 proportion of 1 | Standard Deviation 0.01702 |
| GSK962040 50 mg | Change From Baseline in Hematocrit at Day 4 and Day 8 | Day 4, n=19, 34, 35 | -0.0059 proportion of 1 | Standard Deviation 0.02029 |
| GSK962040 Total | Change From Baseline in Hematocrit at Day 4 and Day 8 | Day 8, n=17, 35, 36 | -0.0039 proportion of 1 | Standard Deviation 0.01682 |
| GSK962040 Total | Change From Baseline in Hematocrit at Day 4 and Day 8 | Day 4, n=19, 34, 35 | -0.0067 proportion of 1 | Standard Deviation 0.02051 |
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.
Time frame: Baseline, Day 4, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | Hemoglobin, Day 8, n=17, 35, 36 | -2.4 Grams per liter | Standard Deviation 4.27 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | MCHC, Day 4, n=13, 24, 24 | -0.0 Grams per liter | Standard Deviation 8.85 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | Hemoglobin, Day 4, n=19, 34, 35 | -2.3 Grams per liter | Standard Deviation 6.53 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | MCHC, Day 8, n=12, 25, 25 | 0.4 Grams per liter | Standard Deviation 8.3 |
| GSK962040 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | Hemoglobin, Day 4, n=19, 34, 35 | -2.0 Grams per liter | Standard Deviation 6.35 |
| GSK962040 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | Hemoglobin, Day 8, n=17, 35, 36 | -2.3 Grams per liter | Standard Deviation 4.71 |
| GSK962040 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | MCHC, Day 4, n=13, 24, 24 | 0.6 Grams per liter | Standard Deviation 8.83 |
| GSK962040 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | MCHC, Day 8, n=12, 25, 25 | -2.3 Grams per liter | Standard Deviation 8.47 |
| GSK962040 Total | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | Hemoglobin, Day 8, n=17, 35, 36 | -2.2 Grams per liter | Standard Deviation 4.64 |
| GSK962040 Total | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | MCHC, Day 4, n=13, 24, 24 | 0.6 Grams per liter | Standard Deviation 8.83 |
| GSK962040 Total | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | Hemoglobin, Day 4, n=19, 34, 35 | -2.3 Grams per liter | Standard Deviation 6.44 |
| GSK962040 Total | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8 | MCHC, Day 8, n=12, 25, 25 | -2.3 Grams per liter | Standard Deviation 8.47 |
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.
Time frame: Baseline, Day 4, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8 | Day 4, n=19, 34, 35 | -0.12 Picograms | Standard Deviation 0.464 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8 | Day 8, n=17, 35, 36 | 0.03 Picograms | Standard Deviation 0.718 |
| GSK962040 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8 | Day 4, n=19, 34, 35 | -0.06 Picograms | Standard Deviation 0.744 |
| GSK962040 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8 | Day 8, n=17, 35, 36 | -0.20 Picograms | Standard Deviation 0.832 |
| GSK962040 Total | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8 | Day 8, n=17, 35, 36 | 0.19 Picograms | Standard Deviation 0.826 |
| GSK962040 Total | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8 | Day 4, n=19, 34, 35 | 0.07 Picograms | Standard Deviation 0.737 |
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.
Time frame: Baseline, Day 4, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8 | Day 4, n=19, 34, 35 | -0.13 Femtoliters | Standard Deviation 1.945 |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8 | Day 8, n=17, 35, 36 | 0.72 Femtoliters | Standard Deviation 1.322 |
| GSK962040 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8 | Day 4, n=19, 34, 35 | -0.14 Femtoliters | Standard Deviation 1.339 |
| GSK962040 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8 | Day 8, n=17, 35, 36 | -0.05 Femtoliters | Standard Deviation 1.401 |
| GSK962040 Total | Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8 | Day 8, n=17, 35, 36 | -0.06 Femtoliters | Standard Deviation 1.381 |
| GSK962040 Total | Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8 | Day 4, n=19, 34, 35 | -0.17 Femtoliters | Standard Deviation 1.334 |
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.
Time frame: Baseline, Day 4, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | WBC, Day 4, n=19, 34, 35 | 0.140 Giga (10^9) cells per liter | Standard Deviation 0.9284 |
| Placebo | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | RBC, Day 8, n=17, 35, 36 | -0.073 Giga (10^9) cells per liter | Standard Deviation 0.127 |
| Placebo | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | RBC, Day 4, n=19, 34, 35 | -0.055 Giga (10^9) cells per liter | Standard Deviation 0.2345 |
| Placebo | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | WBC, Day 8, n=17, 35, 36 | -0.036 Giga (10^9) cells per liter | Standard Deviation 0.8961 |
| GSK962040 50 mg | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | RBC, Day 4, n=19, 34, 35 | 0.068 Giga (10^9) cells per liter | Standard Deviation 0.2138 |
| GSK962040 50 mg | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | WBC, Day 8, n=17, 35, 36 | -0.154 Giga (10^9) cells per liter | Standard Deviation 0.9006 |
| GSK962040 50 mg | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | WBC, Day 4, n=19, 34, 35 | 0.390 Giga (10^9) cells per liter | Standard Deviation 1.0592 |
| GSK962040 50 mg | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | RBC, Day 8, n=17, 35, 36 | 0.041 Giga (10^9) cells per liter | Standard Deviation 0.1752 |
| GSK962040 Total | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | WBC, Day 4, n=19, 34, 35 | 0.392 Giga (10^9) cells per liter | Standard Deviation 1.0437 |
| GSK962040 Total | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | RBC, Day 8, n=17, 35, 36 | -0.043 Giga (10^9) cells per liter | Standard Deviation 0.173 |
| GSK962040 Total | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | WBC, Day 8, n=17, 35, 36 | -0.161 Giga (10^9) cells per liter | Standard Deviation 0.8886 |
| GSK962040 Total | Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8 | RBC, Day 4, n=19, 34, 35 | -0.074 Giga (10^9) cells per liter | Standard Deviation 0.214 |
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.
Time frame: Baseline, Day 4, and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8 | RET, Day 4, n=16, 28, 29 | 0.000 Tera (10^12) cells per liter | Standard Deviation 0.0075 |
| Placebo | Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8 | RET, Day 8, n=13, 28, 29 | 0.004 Tera (10^12) cells per liter | Standard Deviation 0.008 |
| GSK962040 50 mg | Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8 | RET, Day 4, n=16, 28, 29 | 0.002 Tera (10^12) cells per liter | Standard Deviation 0.0093 |
| GSK962040 50 mg | Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8 | RET, Day 8, n=13, 28, 29 | 0.001 Tera (10^12) cells per liter | Standard Deviation 0.0093 |
| GSK962040 Total | Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8 | RET, Day 8, n=13, 28, 29 | 0.001 Tera (10^12) cells per liter | Standard Deviation 0.0095 |
| GSK962040 Total | Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8 | RET, Day 4, n=16, 28, 29 | 0.001 Tera (10^12) cells per liter | Standard Deviation 0.0098 |
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.
Time frame: Baseline, Day 1, and Day 8
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | SBP, Day 1: 0 min, n=19, 37, 38 | -4.0 Millimeters of mercury | Standard Deviation 12.05 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | SBP, Day 8: pre-dose, n=18, 36, 37 | -2.8 Millimeters of mercury | Standard Deviation 13.24 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | SBP, Day 8: 0 min, n=18, 36, 37 | -3.4 Millimeters of mercury | Standard Deviation 11.55 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | DBP, Day 1: 0 min, n=19, 37, 38 | -5.4 Millimeters of mercury | Standard Deviation 7.67 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | DBP, Day 8: pre-dose, n=18, 36, 37 | -4.2 Millimeters of mercury | Standard Deviation 6.88 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | DBP, Day 8: 0 min, n=18, 36, 37 | -3.7 Millimeters of mercury | Standard Deviation 5.81 |
| GSK962040 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | DBP, Day 8: 0 min, n=18, 36, 37 | 0.9 Millimeters of mercury | Standard Deviation 8.32 |
| GSK962040 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | SBP, Day 1: 0 min, n=19, 37, 38 | -2.5 Millimeters of mercury | Standard Deviation 18.66 |
| GSK962040 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | DBP, Day 1: 0 min, n=19, 37, 38 | -0.9 Millimeters of mercury | Standard Deviation 7.51 |
| GSK962040 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | DBP, Day 8: pre-dose, n=18, 36, 37 | -0.9 Millimeters of mercury | Standard Deviation 8.54 |
| GSK962040 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | SBP, Day 8: pre-dose, n=18, 36, 37 | -3.9 Millimeters of mercury | Standard Deviation 13.19 |
| GSK962040 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | SBP, Day 8: 0 min, n=18, 36, 37 | -1.0 Millimeters of mercury | Standard Deviation 15.04 |
| GSK962040 Total | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | SBP, Day 8: pre-dose, n=18, 36, 37 | -3.7 Millimeters of mercury | Standard Deviation 13.06 |
| GSK962040 Total | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | SBP, Day 8: 0 min, n=18, 36, 37 | -1.1 Millimeters of mercury | Standard Deviation 14.84 |
| GSK962040 Total | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | DBP, Day 8: 0 min, n=18, 36, 37 | 0.9 Millimeters of mercury | Standard Deviation 8.21 |
| GSK962040 Total | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | DBP, Day 1: 0 min, n=19, 37, 38 | -0.7 Millimeters of mercury | Standard Deviation 7.55 |
| GSK962040 Total | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | SBP, Day 1: 0 min, n=19, 37, 38 | -2.1 Millimeters of mercury | Standard Deviation 18.58 |
| GSK962040 Total | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8 | DBP, Day 8: pre-dose, n=18, 36, 37 | -0.8 Millimeters of mercury | Standard Deviation 8.48 |
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.
Time frame: Baseline, Day 1, and Day 8
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | Baseline, n=19, 37 | 99.6 Minutes | Standard Deviation 21.26 |
| Placebo | Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | Day 1, n=19, 37 | 97.5 Minutes | Standard Deviation 15.81 |
| Placebo | Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | Day 8, n=17, 36 | 98.7 Minutes | Standard Deviation 25.03 |
| GSK962040 50 mg | Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | Day 1, n=19, 37 | 91.9 Minutes | Standard Deviation 21.47 |
| GSK962040 50 mg | Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | Day 8, n=17, 36 | 90.6 Minutes | Standard Deviation 26.75 |
| GSK962040 50 mg | Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | Baseline, n=19, 37 | 96.9 Minutes | Standard Deviation 21.67 |
Comparison: GSK962040 50 mg Vs Placebo Day 195% CI: [-16.015, 7.537]
Comparison: GSK962040 50 mg Vs Placebo Day 895% CI: [-17.567, 6.914]
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.
Time frame: Day 1 and Day 8
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK962040 50 mg | 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 | AUC(0-5.5): Day 1 | 1632.5 Nanograms.hour/milliliter | Geometric Coefficient of Variation 38.1 |
| GSK962040 50 mg | 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 | AUC(0-5.5): Day 8 | 3036.9 Nanograms.hour/milliliter | Geometric Coefficient of Variation 45.8 |
| GSK962040 50 mg | 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 | AUC(0-inf): Day 1 | 2972.8 Nanograms.hour/milliliter | Geometric Coefficient of Variation 49.2 |
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.
Time frame: Day 1 and Day 8
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK962040 50 mg | GSK962040 Cmax at Day1 and Day 8 | Day 1 | 501.0 Nanograms/milliliter | Geometric Coefficient of Variation 45.4 |
| GSK962040 50 mg | GSK962040 Cmax at Day1 and Day 8 | Day 8 | 788.3 Nanograms/milliliter | Geometric Coefficient of Variation 46 |
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.
Time frame: Day 1
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| GSK962040 50 mg | GSK962040 Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) at Day 1 | 41.64 Percentage | Geometric Coefficient of Variation 28.9 |
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.
Time frame: Day 1 and Day 8
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK962040 50 mg | GSK962040 Tmax at Day1 and Day 8 | Day 1 | 0.750 Hours |
| GSK962040 50 mg | GSK962040 Tmax at Day1 and Day 8 | Day 8 | 1.000 Hours |
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.
Time frame: 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)
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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) | Day 1, 180 minutes post-dose, n=19, 37 | 31.0 Scores on a scale | Standard Deviation 17.1 |
| Placebo | 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) | Day 1, 240 minutes post-dose, n=19, 37 | 32.7 Scores on a scale | Standard Deviation 20.5 |
| Placebo | 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) | Day 8, 120 minutes post-dose, n=18, 36 | 32.3 Scores on a scale | Standard Deviation 14.9 |
| Placebo | 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) | Day 8, 240 minutes post-dose, n=18, 36 | 37.1 Scores on a scale | Standard Deviation 20.19 |
| Placebo | 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) | Follow-up, n=19, 37 | 30.3 Scores on a scale | Standard Deviation 13.45 |
| Placebo | 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) | Baseline, pre-dose, n=19, 37 | 42.2 Scores on a scale | Standard Deviation 14.63 |
| Placebo | 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) | Baseline, 120 minutes post-dose, n=19, 37 | 33.1 Scores on a scale | Standard Deviation 16.61 |
| Placebo | 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) | Baseline, 180 minutes post-dose, n=19, 36 | 30.3 Scores on a scale | Standard Deviation 14.55 |
| Placebo | 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) | Baseline, 240 minutes post-dose, n=19, 37 | 31.6 Scores on a scale | Standard Deviation 16.27 |
| Placebo | 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) | Day 1, pre-dose, n=19, 37 | 40.4 Scores on a scale | Standard Deviation 17.56 |
| Placebo | 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) | Day 1,120 minutes post-dose, n=19, 37 | 32.3 Scores on a scale | Standard Deviation 15.01 |
| Placebo | 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) | Day 8, pre-dose n=18, 36 | 44.2 Scores on a scale | Standard Deviation 19.25 |
| Placebo | 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) | Day 8, 180 minutes post-dose, n=18, 36 | 33.3 Scores on a scale | Standard Deviation 16.17 |
| GSK962040 50 mg | 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) | Day 8, pre-dose n=18, 36 | 34.0 Scores on a scale | Standard Deviation 17.46 |
| GSK962040 50 mg | 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) | Day 1, 180 minutes post-dose, n=19, 37 | 25.5 Scores on a scale | Standard Deviation 18.04 |
| GSK962040 50 mg | 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) | Baseline, 240 minutes post-dose, n=19, 37 | 29.2 Scores on a scale | Standard Deviation 16.62 |
| GSK962040 50 mg | 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) | Day 8, 120 minutes post-dose, n=18, 36 | 24.2 Scores on a scale | Standard Deviation 14.24 |
| GSK962040 50 mg | 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) | Day 8, 180 minutes post-dose, n=18, 36 | 25.1 Scores on a scale | Standard Deviation 14.27 |
| GSK962040 50 mg | 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) | Day 1, pre-dose, n=19, 37 | 34.9 Scores on a scale | Standard Deviation 17.97 |
| GSK962040 50 mg | 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) | Follow-up, n=19, 37 | 24.9 Scores on a scale | Standard Deviation 11.79 |
| GSK962040 50 mg | 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) | Day 1,120 minutes post-dose, n=19, 37 | 26.2 Scores on a scale | Standard Deviation 16.25 |
| GSK962040 50 mg | 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) | Baseline, pre-dose, n=19, 37 | 38.0 Scores on a scale | Standard Deviation 18.95 |
| GSK962040 50 mg | 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) | Day 1, 240 minutes post-dose, n=19, 37 | 27.2 Scores on a scale | Standard Deviation 17.68 |
| GSK962040 50 mg | 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) | Baseline, 120 minutes post-dose, n=19, 37 | 27.7 Scores on a scale | Standard Deviation 16.04 |
| GSK962040 50 mg | 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) | Day 8, 240 minutes post-dose, n=18, 36 | 25.4 Scores on a scale | Standard Deviation 15.27 |
| GSK962040 50 mg | 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) | Baseline, 180 minutes post-dose, n=19, 36 | 27.5 Scores on a scale | Standard Deviation 14.21 |
Comparison: Pre dose: GSK962040 50 mg Vs Placebo Day 195% CI: [-9.07, 2.78]
Comparison: 120 min PD: GSK962040 50 mg Vs Placebo Day 195% CI: [-9.11, 2.75]
Comparison: 180 min PD: GSK962040 50 mg Vs Placebo Day 1:95% CI: [-9.59, 2.27]
Comparison: 240 min PD: GSK962040 50 mg Vs Placebo Day 195% CI: [-10.07, 1.76]
Comparison: Pre dose: GSK962040 50 mg Vs Placebo Day 895% CI: [-12.79, -0.81]
Comparison: 120 min PD: GSK962040 50 mg Vs Placebo Day 895% CI: [-9.96, 2.03]
Comparison: 180 min PD: GSK962040 50 mg Vs Placebo Day 895% CI: [-11.29, 0.71]
Comparison: 240 min PD: GSK962040 50 mg Vs Placebo Day 895% CI: [-14.88, -2.91]
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.
Time frame: Baseline, Day 1, and Day 8 at pre-levodopa dose
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part I: Baseline, n=19, 37 | 9.1 Scores on a scale | Standard Deviation 4.56 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part II: Day 8, n=18, 36 | 15.3 Scores on a scale | Standard Deviation 9.29 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part III: Day 1, n=19, 37 | 40.4 Scores on a scale | Standard Deviation 17.56 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Total: Baseline, n=19, 37 | 71.7 Scores on a scale | Standard Deviation 23.53 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part I: Day 1, n=19, 37 | 10.1 Scores on a scale | Standard Deviation 4.98 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part I: Day 8, n=18, 36 | 10.0 Scores on a scale | Standard Deviation 5.25 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part II: Baseline, n=19, 37 | 14.9 Scores on a scale | Standard Deviation 7.09 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part II: Day 1, n=19, 37 | 16.1 Scores on a scale | Standard Deviation 9.09 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part III: Baseline, n=19, 37 | 42.2 Scores on a scale | Standard Deviation 14.63 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part III: Day 8, n=18, 36 | 44.2 Scores on a scale | Standard Deviation 19.25 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part IV: Baseline, n=19, 37 | 5.5 Scores on a scale | Standard Deviation 2.7 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part IV: Day 1, n=19, 37 | 5.9 Scores on a scale | Standard Deviation 3.07 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part IV: Day 8, n=18, 36 | 5.7 Scores on a scale | Standard Deviation 3.79 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Total: Day 1, n=19, 37 | 72.5 Scores on a scale | Standard Deviation 29.01 |
| Placebo | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Total: Day 8, n=18, 36 | 75.2 Scores on a scale | Standard Deviation 34.27 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Total: Day 8, n=18, 36 | 55.9 Scores on a scale | Standard Deviation 25.34 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part I: Day 8, n=18, 36 | 7.1 Scores on a scale | Standard Deviation 4.67 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part II: Day 1, n=19, 37 | 11.5 Scores on a scale | Standard Deviation 6.54 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part II: Day 8, n=18, 36 | 10.3 Scores on a scale | Standard Deviation 6.37 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part IV: Day 1, n=19, 37 | 5.2 Scores on a scale | Standard Deviation 3.61 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part III: Day 8, n=18, 36 | 34.0 Scores on a scale | Standard Deviation 17.46 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part IV: Baseline, n=19, 37 | 5.3 Scores on a scale | Standard Deviation 3.63 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part III: Baseline, n=19, 37 | 38.0 Scores on a scale | Standard Deviation 18.95 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Total: Baseline, n=19, 37 | 65.8 Scores on a scale | Standard Deviation 27.02 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part I: Baseline, n=19, 37 | 10.1 Scores on a scale | Standard Deviation 6.17 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part III: Day 1, n=19, 37 | 34.9 Scores on a scale | Standard Deviation 17.97 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part I: Day 1, n=19, 37 | 8.6 Scores on a scale | Standard Deviation 5.12 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Total: Day 1, n=19, 37 | 60.2 Scores on a scale | Standard Deviation 25.9 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part IV: Day 8, n=18, 36 | 4.5 Scores on a scale | Standard Deviation 3.41 |
| GSK962040 50 mg | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose) | Part II: Baseline, n=19, 37 | 12.5 Scores on a scale | Standard Deviation 6.33 |
Comparison: Part I-GSK962040 50 mg Vs Placebo Day 195% CI: [-3.9, -0.41]
Comparison: Part I-GSK962040 50 mg Vs Placebo Day 895% CI: [-5.41, -1.85]
Comparison: Part II- GSK962040 50 mg Vs Placebo Day 195% CI: [-4.65, 0.07]
Comparison: Part II- GSK962040 50 mg Vs Placebo Day 895% CI: [-4.85, -0.07]
Comparison: Part III -GSK962040 50 mg Vs Placebo Day 895% CI: [-10.28, -0.49]
Comparison: Part IV-GSK962040 50 mg Vs Placebo Day 195% CI: [-1.65, 0.54]
Comparison: Part IV-GSK962040 50 mg Vs Placebo Day 895% CI: [-2.02, 0.22]
Comparison: Total- GSK962040 50 mg Vs Placebo Day 195% CI: [-13.77, 0.39]
Comparison: Total- GSK962040 50 mg Vs Placebo Day 895% CI: [-19.67, -5.29]
Comparison: Part III- GSK962040 50 mg Vs Placebo Day 195% CI: [-6.53, 3.13]
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.
Time frame: From the start of study medication until Follow-up (up to Day 25)
Population: All Subjects Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any AE | 17 Participants |
| Placebo | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any SAE | 2 Participants |
| GSK962040 50 mg | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any AE | 23 Participants |
| GSK962040 50 mg | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any SAE | 2 Participants |
| GSK962040 Total | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any AE | 24 Participants |
| GSK962040 Total | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Any SAE | 2 Participants |
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.
Time frame: Day 1 and Day 8
Population: ASP. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: pre-dose, Abnormal - Not CS, n=19, 37, 38 | 5 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: pre-dose, Abnormal - CS, n=18, 36, 37 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: pre-dose, Abnormal - Not CS, n=18, 36, 37 | 4 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: 0 min, Abnormal - CS, n=19, 37, 38 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: 0 min, Normal, n=19, 37, 38 | 12 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: 0 min, Abnormal - CS, n=18, 36, 37 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: pre-dose, Abnormal - CS, n=19, 37, 38 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: 0 min, Abnormal - Not CS, n=19, 37, 38 | 7 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: 0 min, Abnormal - Not CS, n=18, 36, 37 | 6 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: 0 min, Normal, n=18, 36, 37 | 12 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: pre-dose, Normal, n=18, 36, 37 | 14 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: pre-dose, Normal, n=19, 37, 38 | 14 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: pre-dose, Normal, n=18, 36, 37 | 18 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: pre-dose, Abnormal - Not CS, n=18, 36, 37 | 17 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: pre-dose, Abnormal - CS, n=19, 37, 38 | 1 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: pre-dose, Abnormal - CS, n=18, 36, 37 | 1 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: 0 min, Abnormal - Not CS, n=18, 36, 37 | 16 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: 0 min, Abnormal - Not CS, n=19, 37, 38 | 20 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: 0 min, Abnormal - CS, n=18, 36, 37 | 1 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: pre-dose, Abnormal - Not CS, n=19, 37, 38 | 19 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: pre-dose, Normal, n=19, 37, 38 | 17 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: 0 min, Normal, n=19, 37, 38 | 16 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: 0 min, Abnormal - CS, n=19, 37, 38 | 1 Participants |
| GSK962040 50 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: 0 min, Normal, n=18, 36, 37 | 19 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: 0 min, Abnormal - CS, n=18, 36, 37 | 1 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: 0 min, Abnormal - Not CS, n=19, 37, 38 | 21 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: pre-dose, Abnormal - CS, n=18, 36, 37 | 1 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: 0 min, Normal, n=18, 36, 37 | 20 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: pre-dose, Normal, n=19, 37, 38 | 18 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: pre-dose, Abnormal - Not CS, n=19, 37, 38 | 19 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: pre-dose, Abnormal - CS, n=19, 37, 38 | 1 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: 0 min, Normal, n=19, 37, 38 | 16 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 1: 0 min, Abnormal - CS, n=19, 37, 38 | 1 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: pre-dose, Normal, n=18, 36, 37 | 19 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: pre-dose, Abnormal - Not CS, n=18, 36, 37 | 17 Participants |
| GSK962040 Total | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8 | Day 8: 0 min, Abnormal - Not CS, n=18, 36, 37 | 16 Participants |
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.
Time frame: 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)
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Day 1: 120 min, n=19, 35 | 99.9 Finger taps per minute | Standard Deviation 50.51 |
| Placebo | 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 | Baseline: 0 min, n=19, 35 | 91.2 Finger taps per minute | Standard Deviation 49.84 |
| Placebo | 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 | Baseline: 120 min, n=19, 37 | 92.6 Finger taps per minute | Standard Deviation 40.99 |
| Placebo | 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 | Day 1: 30 min, n=18, 35 | 93.4 Finger taps per minute | Standard Deviation 43.95 |
| Placebo | 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 | Day 1: 90 min, n=19, 34 | 97.7 Finger taps per minute | Standard Deviation 50.46 |
| Placebo | 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 | Day 8: pre-dose, n=18, 35 | 95.7 Finger taps per minute | Standard Deviation 40.9 |
| Placebo | 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 | Day 8: 30 min, n=18, 34 | 95.8 Finger taps per minute | Standard Deviation 45.07 |
| Placebo | 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 | Day 8: 90 min, n=18, 34 | 95.0 Finger taps per minute | Standard Deviation 48.82 |
| Placebo | 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 | Day 8: 120 min, n=18, 35 | 97.2 Finger taps per minute | Standard Deviation 47.67 |
| Placebo | 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 | Day 8: 240 min, n=18, 35 | 98.3 Finger taps per minute | Standard Deviation 53.3 |
| Placebo | 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 | Day 1: 0 min, n=19, 364 | 90.7 Finger taps per minute | Standard Deviation 40.78 |
| Placebo | 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 | Baseline: 30 min, n=19, 34 | 89.3 Finger taps per minute | Standard Deviation 42.91 |
| Placebo | 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 | Baseline: 60 min, n=19, 36 | 88.6 Finger taps per minute | Standard Deviation 42.32 |
| Placebo | 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 | Baseline: 90 min, n=19, 36 | 91.2 Finger taps per minute | Standard Deviation 44.14 |
| Placebo | 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 | Baseline: 180 min, n=19, 37 | 94.1 Finger taps per minute | Standard Deviation 47.19 |
| Placebo | 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 | Baseline: 240 min, n=19, 37 | 95.2 Finger taps per minute | Standard Deviation 44.6 |
| Placebo | 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 | Day 1: pre-dose, n=19, 36 | 92.3 Finger taps per minute | Standard Deviation 43.44 |
| Placebo | 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 | Day 1: 60 min, n=18, 35 | 93.8 Finger taps per minute | Standard Deviation 44.8 |
| Placebo | 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 | Baseline: pre-dose, n=19, 37 | 92.4 Finger taps per minute | Standard Deviation 47.53 |
| Placebo | 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 | Day 1: 180 min, n=18, 36 | 99.0 Finger taps per minute | Standard Deviation 49.44 |
| Placebo | 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 | Day 1: 240 min, n=18, 36 | 98.2 Finger taps per minute | Standard Deviation 51.97 |
| Placebo | 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 | Day 8: 0 min, n=18, 35 | 92.0 Finger taps per minute | Standard Deviation 44.3 |
| Placebo | 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 | Day 8: 60 min, n=18, 35 | 94.6 Finger taps per minute | Standard Deviation 46.8 |
| Placebo | 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 | Day 8: 180 min, n=18, 34 | 96.8 Finger taps per minute | Standard Deviation 52.5 |
| Placebo | 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 | Follow-up: n=18, 35 | 104.4 Finger taps per minute | Standard Deviation 48.13 |
| GSK962040 50 mg | 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 | Day 8: 240 min, n=18, 35 | 102.8 Finger taps per minute | Standard Deviation 51.84 |
| GSK962040 50 mg | 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 | Baseline: pre-dose, n=19, 37 | 77.8 Finger taps per minute | Standard Deviation 38 |
| GSK962040 50 mg | 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 | Baseline: 60 min, n=19, 36 | 89.3 Finger taps per minute | Standard Deviation 45.32 |
| GSK962040 50 mg | 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 | Baseline: 0 min, n=19, 35 | 80.1 Finger taps per minute | Standard Deviation 35.28 |
| GSK962040 50 mg | 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 | Baseline: 90 min, n=19, 36 | 90.8 Finger taps per minute | Standard Deviation 45.18 |
| GSK962040 50 mg | 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 | Day 1: 120 min, n=19, 35 | 96.4 Finger taps per minute | Standard Deviation 42.06 |
| GSK962040 50 mg | 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 | Baseline: 120 min, n=19, 37 | 92.0 Finger taps per minute | Standard Deviation 43.37 |
| GSK962040 50 mg | 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 | Day 8: 60 min, n=18, 35 | 93.2 Finger taps per minute | Standard Deviation 39.01 |
| GSK962040 50 mg | 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 | Day 1: 30 min, n=18, 35 | 92.4 Finger taps per minute | Standard Deviation 49.92 |
| GSK962040 50 mg | 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 | Baseline: 180 min, n=19, 37 | 92.8 Finger taps per minute | Standard Deviation 44.86 |
| GSK962040 50 mg | 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 | Day 1: 90 min, n=19, 34 | 91.4 Finger taps per minute | Standard Deviation 42.09 |
| GSK962040 50 mg | 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 | Day 1: 240 min, n=18, 36 | 97.6 Finger taps per minute | Standard Deviation 48.4 |
| GSK962040 50 mg | 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 | Day 1: 180 min, n=18, 36 | 92.3 Finger taps per minute | Standard Deviation 41.01 |
| GSK962040 50 mg | 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 | Day 8: pre-dose, n=18, 35 | 92.8 Finger taps per minute | Standard Deviation 43.92 |
| GSK962040 50 mg | 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 | Day 8: 0 min, n=18, 35 | 91.1 Finger taps per minute | Standard Deviation 42.9 |
| GSK962040 50 mg | 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 | Baseline: 240 min, n=19, 37 | 93.2 Finger taps per minute | Standard Deviation 46.17 |
| GSK962040 50 mg | 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 | Day 8: 30 min, n=18, 34 | 92.2 Finger taps per minute | Standard Deviation 41.14 |
| GSK962040 50 mg | 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 | Follow-up: n=18, 35 | 105.7 Finger taps per minute | Standard Deviation 56.59 |
| GSK962040 50 mg | 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 | Day 8: 90 min, n=18, 34 | 95.5 Finger taps per minute | Standard Deviation 42.6 |
| GSK962040 50 mg | 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 | Day 1: pre-dose, n=19, 36 | 85.1 Finger taps per minute | Standard Deviation 40.05 |
| GSK962040 50 mg | 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 | Day 8: 120 min, n=18, 35 | 97.4 Finger taps per minute | Standard Deviation 42.34 |
| GSK962040 50 mg | 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 | Day 1: 0 min, n=19, 364 | 86.8 Finger taps per minute | Standard Deviation 44.65 |
| GSK962040 50 mg | 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 | Day 8: 180 min, n=18, 34 | 101.2 Finger taps per minute | Standard Deviation 49.86 |
| GSK962040 50 mg | 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 | Day 1: 60 min, n=18, 35 | 94.6 Finger taps per minute | Standard Deviation 44.06 |
| GSK962040 50 mg | 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 | Baseline: 30 min, n=19, 34 | 85.2 Finger taps per minute | Standard Deviation 41.45 |
Comparison: Pre-dose: Day GSK962040 50 mg Vs Placebo Day 195% CI: [-21.79, 16.13]
Comparison: 0 min PD: GSK962040 50 mg Vs Placebo Day 195% CI: [-18.39, 19.56]
Comparison: Day 1, 30 min PD95% CI: [-17.18, 20.86]
Comparison: 60 min PD: GSK962040 50 mg Vs Placebo Day 195% CI: [-18.72, 19.28]
Comparison: 90 min PD: GSK962040 50 mg Vs Placebo Day 195% CI: [-22.35, 15.58]
Comparison: 120 min PD: GSK962040 50 mg Vs Placebo Day 195% CI: [-23.13, 14.76]
Comparison: 180 min PD: GSK962040 50 mg Vs Placebo Day 195% CI: [-25.36, 12.58]
Comparison: 240 min PD: GSK962040 50 mg Vs Placebo Day 195% CI: [-18.2, 19.75]
Comparison: Pre-dose: GSK962040 50 mg Vs Placebo Day 895% CI: [-18.51, 19.52]
Comparison: 0 min PD: GSK962040 50 mg Vs Placebo Day 895% CI: [-15.7, 22.33]
Comparison: 30 min PD: GSK962040 50 mg Vs Placebo Day 895% CI: [-21.97, 16.08]
Comparison: 60 min PD: GSK962040 50 mg Vs Placebo Day 895% CI: [-22.13, 15.88]
Comparison: 90 min PD: GSK962040 50 mg Vs Placebo Day 895% CI: [-20.4, 17.63]
Comparison: 120 min PD: GSK962040 50 mg Vs Placebo Day 895% CI: [-19.7, 18.28]
Comparison: 180 min PD: GSK962040 50 mg Vs Placebo Day 895% CI: [-15.98, 22.02]
Comparison: 240 min PD: GSK962040 50 mg Vs Placebo Day 895% CI: [-14.91, 23.07]
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.
Time frame: 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)
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Baseline: ON without dyskinesia, n=18, 37 | 10.11 hours | Standard Deviation 4.069 |
| Placebo | 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 | Baseline: ON with non-TD, n=18, 37 | 1.10 hours | Standard Deviation 1.787 |
| Placebo | 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 | Baseline: ON with TD, n=18, 37 | 0.54 hours | Standard Deviation 1.24 |
| Placebo | 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 | Treatment period: ON with non-TD, n=18, 36 | 0.79 hours | Standard Deviation 1.875 |
| Placebo | 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 | Week 2 of FU: ON without dyskinesia, n=16, 32 | 11.13 hours | Standard Deviation 4.138 |
| Placebo | 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 | Week 2 of FU: ON with non-TD, n=16, 32 | 0.22 hours | Standard Deviation 0.875 |
| Placebo | 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 | Baseline: ON, n=18, 37 | 11.21 hours | Standard Deviation 3.602 |
| Placebo | 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 | Baseline: OFF, n=18, 37 | 4.92 hours | Standard Deviation 3.417 |
| Placebo | 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 | Treatment period: ON, n=18, 36 | 10.61 hours | Standard Deviation 3.927 |
| Placebo | 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 | Treatment period: ON without dyskinesia, n=18,36 | 9.82 hours | Standard Deviation 4.042 |
| Placebo | 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 | Treatment period: ON with TD, n=18, 36 | 0.47 hours | Standard Deviation 1.548 |
| Placebo | 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 | Treatment period: OFF, n=18, 36 | 5.57 hours | Standard Deviation 4.364 |
| Placebo | 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 | Week 1 of FU: ON, n=18, 36 | 11.00 hours | Standard Deviation 3.309 |
| Placebo | 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 | Week 1 of FU: ON without dyskinesia, n=18, 36 | 10.17 hours | Standard Deviation 4.232 |
| Placebo | 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 | Week 1 of FU: ON with non-TD, n=18, 36 | 0.83 hours | Standard Deviation 1.933 |
| Placebo | 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 | Week 1 of FU: ON with TD, n=18, 36 | 0.71 hours | Standard Deviation 2.083 |
| Placebo | 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 | Week 1 of FU: OFF, n=18, 36 | 4.83 hours | Standard Deviation 3.7 |
| Placebo | 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 | Week 2 of FU: ON, n=16, 32 | 11.34 hours | Standard Deviation 3.58 |
| Placebo | 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 | Week 2 of FU: ON with TD, n=16, 32 | 0.38 hours | Standard Deviation 1.5 |
| Placebo | 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 | Week 2 of FU: OFF, n=16, 32 | 4.47 hours | Standard Deviation 3.601 |
| GSK962040 50 mg | 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 | Treatment period: ON with non-TD, n=18, 36 | 1.98 hours | Standard Deviation 2.987 |
| GSK962040 50 mg | 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 | Baseline: ON without dyskinesia, n=18, 37 | 9.65 hours | Standard Deviation 3.787 |
| GSK962040 50 mg | 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 | Week 1 of FU: ON with non-TD, n=18, 36 | 1.50 hours | Standard Deviation 2.369 |
| GSK962040 50 mg | 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 | Baseline: ON with non-TD, n=18, 37 | 1.66 hours | Standard Deviation 2.956 |
| GSK962040 50 mg | 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 | Treatment period: ON with TD, n=18, 36 | 0.59 hours | Standard Deviation 1.985 |
| GSK962040 50 mg | 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 | Treatment period: ON, n=18, 36 | 12.44 hours | Standard Deviation 3.375 |
| GSK962040 50 mg | 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 | Treatment period: ON without dyskinesia, n=18,36 | 10.47 hours | Standard Deviation 4.479 |
| GSK962040 50 mg | 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 | Week 2 of FU: ON without dyskinesia, n=16, 32 | 9.98 hours | Standard Deviation 4.872 |
| GSK962040 50 mg | 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 | Week 1 of FU: OFF, n=18, 36 | 3.31 hours | Standard Deviation 2.642 |
| GSK962040 50 mg | 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 | Week 2 of FU: ON, n=16, 32 | 11.69 hours | Standard Deviation 3.562 |
| GSK962040 50 mg | 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 | Treatment period: OFF, n=18, 36 | 2.94 hours | Standard Deviation 2.954 |
| GSK962040 50 mg | 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 | Week 1 of FU: ON with TD, n=18, 36 | 0.52 hours | Standard Deviation 1.986 |
| GSK962040 50 mg | 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 | Week 2 of FU: OFF, n=16, 32 | 3.36 hours | Standard Deviation 2.857 |
| GSK962040 50 mg | 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 | Week 1 of FU: ON, n=18, 36 | 12.13 hours | Standard Deviation 3.134 |
| GSK962040 50 mg | 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 | Baseline: ON, n=18, 37 | 11.31 hours | Standard Deviation 3.021 |
| GSK962040 50 mg | 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 | Baseline: ON with TD, n=18, 37 | 0.40 hours | Standard Deviation 1.292 |
| GSK962040 50 mg | 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 | Week 2 of FU: ON with non-TD, n=16, 32 | 1.70 hours | Standard Deviation 2.838 |
| GSK962040 50 mg | 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 | Baseline: OFF, n=18, 37 | 4.23 hours | Standard Deviation 2.484 |
| GSK962040 50 mg | 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 | Week 1 of FU: ON without dyskinesia, n=18, 36 | 10.63 hours | Standard Deviation 3.948 |
| GSK962040 50 mg | 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 | Week 2 of FU: ON with TD, n=16, 32 | 0.80 hours | Standard Deviation 2.362 |
Comparison: OFF: Treatment Period95% CI: [-3.71, -0.9]
Comparison: ON: Treatment Period95% CI: [0.28, 3.48]
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.
Time frame: Baseline and Days 1, 2, 3, 4, 5, 6, 7, 8, and 9
Population: PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 8, n=17, 34 | 191.2 Milligrams | Standard Deviation 175.43 |
| Placebo | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 2, n=19, 36 | 465.8 Milligrams | Standard Deviation 229.61 |
| Placebo | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 4, n=19, 36 | 481.6 Milligrams | Standard Deviation 241.5 |
| Placebo | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 9, n=0, 5 | 0.0 Milligrams | Standard Deviation 0 |
| Placebo | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 1, n=19, 37 | 353.9 Milligrams | Standard Deviation 174.85 |
| Placebo | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 3, n=19, 36 | 481.6 Milligrams | Standard Deviation 243.79 |
| Placebo | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 5, n=19, 36 | 484.2 Milligrams | Standard Deviation 243.13 |
| Placebo | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 6, n=17, 36 | 516.2 Milligrams | Standard Deviation 249.21 |
| Placebo | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 7, n=17, 35 | 486.8 Milligrams | Standard Deviation 247.51 |
| Placebo | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Baseline, n=19, 37 | 113.2 Milligrams | Standard Deviation 41.14 |
| GSK962040 50 mg | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 5, n=19, 36 | 503.0 Milligrams | Standard Deviation 293.48 |
| GSK962040 50 mg | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 1, n=19, 37 | 368.6 Milligrams | Standard Deviation 216.54 |
| GSK962040 50 mg | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 7, n=17, 35 | 499.6 Milligrams | Standard Deviation 310.57 |
| GSK962040 50 mg | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 2, n=19, 36 | 514.5 Milligrams | Standard Deviation 300.44 |
| GSK962040 50 mg | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 3, n=19, 36 | 516.9 Milligrams | Standard Deviation 299.98 |
| GSK962040 50 mg | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 4, n=19, 36 | 518.3 Milligrams | Standard Deviation 313.07 |
| GSK962040 50 mg | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 8, n=17, 34 | 281.3 Milligrams | Standard Deviation 234 |
| GSK962040 50 mg | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 6, n=17, 36 | 511.3 Milligrams | Standard Deviation 307.31 |
| GSK962040 50 mg | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Day 9, n=0, 5 | 235.0 Milligrams | Standard Deviation 121.96 |
| GSK962040 50 mg | Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Baseline, n=19, 37 | 164.5 Milligrams | Standard Deviation 119.66 |