Trials / Completed
CompletedNCT01039974
GSK962040 Drug-drug Interaction Study With Ketoconazole
An Open-label, Randomized, Single Sequence, Two Period Study to Assess the Effect of Repeat Oral Dosing of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of GSK962040 in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK962040 | GSK962040. Planned doses per cohort as follows: Cohort 1 planned dose = 10 mg; Cohort 2 to be determined based on data from Cohort 1 |
| DRUG | Ketoconazole | 400 mg |
Timeline
- Start date
- 2009-09-18
- Primary completion
- 2009-11-30
- Completion
- 2009-11-30
- First posted
- 2009-12-25
- Last updated
- 2017-06-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01039974. Inclusion in this directory is not an endorsement.