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This study will evaluate the safety, tolerability and exposure of repeat escalating oral doses of GSK962040.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving GSK962040 in cohort 1 | Experimental | Eligible subjects will receive repeat oral doses of GSK962040 given as 10 milligrams once daily tablet for 14 days. |
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| Subjects receiving GSK962040 in cohort 2 | Experimental | Eligible subjects will receive repeat oral doses of GSK962040 given as 30 milligrams once daily tablet for 14 days. |
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| Subjects receiving GSK962040 in cohort 3 | Experimental | Eligible subjects will receive repeat oral doses of GSK962040 given as 100 milligrams once daily tablet for 14 days. |
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| Subjects receiving placebo in cohort 1, 2 and 3 | Placebo Comparator | Eligible subjects will receive repeat oral doses of placebo tablets given once daily for 14 days in cohort 1, 2 and 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK962040 | Drug | GSK962040 tablets will be available in dosing strengths of 1 milligram, 5 milligrams, 25 milligrams given orally, once daily, in the morning, in a fasted state. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, tolerability, and PK of GSK962040 from all adverse event reporting, 12-lead ECGs, vital signs, observation, safety laboratory tests and GI symptom diary; (AUC, Cmax, Tmax, accumulation ratio (Ro), half life and time invariance ratio (Rs)). |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on gastric emptying.Effect of liquid meal on PK of GSK962040. Effect on bowel movement parameters | ||
| Pharmacokinetic parameters following repeated oral doses of GSK962040 during a simulated liquid enteral feed meal: Cmax, Tmax, and AUC(0-t) |
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Inclusion Criteria:
Exclusion Inclusion:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | Cambridgeshire | CB2 2GG | United Kingdom |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| Results for study MOT109681 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| MOT109681 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| C541863 | N-(3-fluorophenyl)-1-((4-(((3S)-3-methyl-1-piperazinyl)methyl)phenyl)acetyl)-4-piperidinamine |
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| Placebo | Drug | Placebo tablets will be given orally, once daily, in the morning, in a fasted state. |
|
| Gastric emptying, as measured by the 13C octanoic acid breath test:Gastric half emptying time (t1/2b), Duration of the lag time (tlag), Gastric evacuation coefficient (GEC) |
| Bowel movement parameters: Time to first bowel movement after first dose, Daily bowel movement count, Daily average bowel movement Bristol Stool Form scale |
| Pharmacokinetic parameters following repeated every other day (QOD) oral doses of GSK962040: Cmax, Tmax, AUC(0-t), accumulation ratio (Ro), and, if possible, half-life, and time invariance ratio (Rs), as needed. |
For additional information about this study please refer to the GSK Clinical Study Register |
| MOT109681 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MOT109681 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MOT109681 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MOT109681 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MOT109681 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |