Trial · NCT01602549
A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying
NCT01602549, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying. Trials, record NCT01602549. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01602549
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric Emptying
- NCT number
- NCT01602549
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Gastroparesis
- Interventions
- GSK962040 (25 mg tablet), Placebo
- First posted
- 2012-05-21
- Last updated
- 2017-02-06
- Results first posted
- 2017-02-06
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| 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) | 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. |
| 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 | 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. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline | Baseline | Pharmacodynamic (PD)/Efficacy Population: participants receiving \>=1 dose placebo/GSK962040 50 mg. Only those participants available at the specified time point were analyzed. | Nanograms*hour/milliliter/milligram | GEOMETRIC_MEAN |
| PRIMARY | Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | Day 1 and Day 8 | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Nanograms*hour/milliliter/milligram | LEAST_SQUARES_MEAN |
| PRIMARY | Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline | Baseline | PD/Efficacy Population. Only those participants available at the specified time point were analyzed. | Nanograms/milliliter/milligram | GEOMETRIC_MEAN |
| PRIMARY | Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | Day 1 and Day 8 | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Nanograms/milliliter/milligram | LEAST_SQUARES_MEAN |
| PRIMARY | L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8 | Baseline, Day 1, and Day 8 | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Hours | MEDIAN |
| PRIMARY | L-DOPA Terminal Phase Half-life (t1/2) at Baseline, Day 1, and Day 8 | Baseline, Day 1, and Day 8 | |||
| SECONDARY | Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8 | Baseline, Day 1, and Day 8 | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Minutes | MEAN |
| SECONDARY | 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 | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Scores on a scale | MEAN |
| 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) | 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) | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | Scores on a scale | MEAN |
| 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 | 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) | PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed. | hours | MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group435
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline | Placebo | 24.13 | Geometric Coefficient of Variation 37.5 | Nanograms*hour/milliliter/milligram | |
| Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline | GSK962040 50 mg | 24.81 | Geometric Coefficient of Variation 36.1 | Nanograms*hour/milliliter/milligram | |
| Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | Placebo | Day 1, n=17, 31 | 26.6 | Standard Error 0.058 | Nanograms*hour/milliliter/milligram |
| Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | GSK962040 50 mg | Day 1, n=17, 31 | 25.7 | Standard Error 0.047 | Nanograms*hour/milliliter/milligram |
| Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | Placebo | Day 8, n=17, 32 | 27.1 | Standard Error 0.058 | Nanograms*hour/milliliter/milligram |
| Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8 | GSK962040 50 mg | Day 8, n=17, 32 | 24.1 | Standard Error 0.047 | Nanograms*hour/milliliter/milligram |
| Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline | Placebo | 12.77 | Geometric Coefficient of Variation 28.0 | Nanograms/milliliter/milligram | |
| Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline | GSK962040 50 mg | 12.89 | Geometric Coefficient of Variation 42.6 | Nanograms/milliliter/milligram | |
| Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | Placebo | Day 1, n=18, 35 | 13.4 | Standard Error 0.081 | Nanograms/milliliter/milligram |
| Dose-normalized L-DOPA Cmax at Day 1 and Day 8 | GSK962040 50 mg | Day 1, n=18, 35 | 11.6 | Standard Error 0.065 | Nanograms/milliliter/milligram |
1 to 10 of 435Source ClinicalTrials.gov
See all 435 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 19 | |
| Overall Study | STARTED | GSK962040 Total | 38 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | COMPLETED | GSK962040 Total | 37 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | GSK962040 Total | 1 |
Source ClinicalTrials.gov
Adverse events228
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Flushing | Vascular disorders | Placebo | 1 | 19 | |
| other | Flushing | Vascular disorders | GSK962040 50 mg | 0 | 37 | |
| other | Flushing | Vascular disorders | GSK962040 125 mg | 0 | 1 | |
| other | Hypertensive crisis | Vascular disorders | Placebo | 0 | 19 | |
| other | Hypertensive crisis | Vascular disorders | GSK962040 50 mg | 1 | 37 | |
| other | Hypertensive crisis | Vascular disorders | GSK962040 125 mg | 0 | 1 | |
| other | Fatigue | General disorders | Placebo | 2 | 19 | |
| other | Fatigue | General disorders | GSK962040 50 mg | 5 | 37 | |
| other | Fatigue | General disorders | GSK962040 125 mg | 0 | 1 | |
| other | Chills | General disorders | Placebo | 0 | 19 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | GSK962040 50 mg | ||
| Total, all-cause mortality | GSK962040 125 mg | ||
| Total, other adverse events | Placebo | 17 | 19 |
| Total, other adverse events | GSK962040 50 mg | 21 | 37 |
| Total, other adverse events | GSK962040 125 mg | 1 | 1 |
| Total, serious adverse events | Placebo | 2 | 19 |
| Total, serious adverse events | GSK962040 50 mg | 2 | 37 |
| Total, serious adverse events | GSK962040 125 mg | 0 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29278279 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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