Trials / Completed
CompletedNCT00920088
Drug Interaction Study of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 PK and CYP450 Probe Drugs
A Phase I Study to Evaluate the Effect of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 Pharmacokinetics and to Assess the Effect of GSK2248761 on CYP450 Probe Drugs in Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the effect of GSK2448761 on CYP450 metabolic probes and to evaluate the 2-way interaction between GSK2448761 and two ritonavir-boosted protease inhibitors that are commonly used in HIV-infected subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | darunavir/ritonavir | DRV/RTV 600/100mg |
| DRUG | lopinavir/ritonavir | LPV/RTV 400/100mg |
| DRUG | Midazolam | Midazolam 3mg |
| DRUG | Dextromethorphan | Dextromethorphan 30mg |
| DRUG | Flurbiprofen | Flurbiprofen 50mg |
| DRUG | GSK2248761 | NNRTI under investigation |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2009-11-01
- Completion
- 2009-11-01
- First posted
- 2009-06-15
- Last updated
- 2010-11-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00920088. Inclusion in this directory is not an endorsement.