Drug Interaction Study of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 PK and CYP450 Probe Drugs
NCT00920088 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2010-11-03
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
- Healthy Subjects
- Infection, Human Immunodeficiency Virus
Interventions
- 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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2009-11-30
- Completion
- 2009-11-30
Countries
- United States
Study Locations
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