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The purpose of this study is to assess the pharmacodynamic effects (gastric emptying), safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic patients with gastroparesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 Period 1 | Experimental | All patients will receive placebo and 2 of the 3 possible doses of GSK962040 in a randomized, double blind, placebo controlled, incomplete block, three period crossover design. |
|
| Cohort 1 Period 2 | Experimental | All patients will receive placebo and 2 of the 3 possible doses of GSK962040 in a randomized, double blind, placebo controlled, incomplete block, three period crossover design. |
|
| Cohort 1 Period 3 | Experimental | All patients will receive placebo and 2 of the 3 possible doses of GSK962040 in a randomized, double blind, placebo controlled, incomplete block, three period crossover design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK962040 25 mg | Drug | 25 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)) | 1.5 h post dose to 5.5 h post dose | |
| Safety and tolerability of GSK962040 (Change from baseline and number of patients outside the normal range for blood pressure, heart rate, 12-lead ECG parameters) | 2 h post dose | |
| Pharmacokinetic parameters of GSK962040: Cmax, Tmax, AUC(0-t), AUC(0-inf) for single-dose, CL/F, V/F, and, if possible, half-life | 24 h post dose | |
| Safety and tolerability of GSK962040 (Adverse events) | 6 weeks | |
| Safety and tolerability of GSK962040 (Change from baseline in clinical chemistry and hematology parameters) | 24 h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel movement parameters (Time to first bowel movement after first dose, Bowel movement count, Stool consistency (Bristol Stool Form scale)) | 24 h post dose | |
| PK/PD relationship of PP, plasma glucagon, GLP-1, and ghrelin after a single dose of GSK962040. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Leuven | 3000 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26924243 | Derived | Hellstrom PM, Tack J, Johnson LV, Hacquoil K, Barton ME, Richards DB, Alpers DH, Sanger GJ, Dukes GE. The pharmacodynamics, safety and pharmacokinetics of single doses of the motilin agonist, camicinal, in type 1 diabetes mellitus with slow gastric emptying. Br J Pharmacol. 2016 Jun;173(11):1768-77. doi: 10.1111/bph.13475. Epub 2016 Apr 13. |
| 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 |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111809 | 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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 27, 2017 | |
| Reset | May 9, 2017 | |
| Release | Sep 15, 2017 | |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2017 | May 9, 2017 | |||
| Sep 15, 2017 | Aug 15, 2018 |
| 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 comparator |
|
| GSK962040 50 mg | Drug | 50 mg |
|
| GSK962040 1250 mg | Drug | 125 mg |
|
| 0-6 h post dose |
| Plasma glucose | 24 h post dose |
| Food intake | 24 h post dose |
| Stockholm |
| SE-171 76 |
| Sweden |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111809 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111809 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111809 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111809 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111809 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111809 | Informed Consent Form | 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 |