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This study will determine the effect of 400 mg ketoconazole on the pharmacokinetics of a single dose of GSK962040. The results from this study will help to estimate the maximum increase in exposure during concomitant use of strong CYP3A4 inhibitors. This study will also contain an exploratory investigation of biliary secretion of GSK962040 and or its metabolites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohorts 1-2 | Experimental | Cohorts 1 and 2 will complete both periods Period 1 GSK962040 single dose Period 2 Ketoconazole repeat dose (10 days), GSK962040 single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK962040 | Drug | GSK962040. Planned doses per cohort as follows: Cohort 1 planned dose = 10 mg; Cohort 2 to be determined based on data from Cohort 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters (AUC(0-inf), and Cmax) of GSK962040 | Duration of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessments, consisting of AEs, ECGs, vital signs, clinical laboratory tests. | Duration of dosing | |
| Additional pharmacokinetic parameters of GSK962040, i.e., tmax, t1/2, AUC(0-t) | Duration of dosing |
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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 | Buffalo | New York | 14202 | United States |
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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 112648 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112648 | Annotated Case Report Form | 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 |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketoconazole | Drug | 400 mg |
|
| To characterize the nature of the GSK962040-related material in plasma, 24-hour urine, and bile. | 24 h |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112648 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112648 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112648 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112648 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112648 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112648 | 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 |