Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
Phase 1
Completed
- Conditions
- HIV Infections
- Interventions
- Registration Number
- NCT00362726
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description B Atazanavir Sulphate - C Atazanavir Sulphate + Rosiglitazone maleate - E Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate - A Rosiglitazone maleate - D Atazanavir Sulphate + Ritonavir -
- Primary Outcome Measures
Name Time Method To assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of Rosiglitazone in healthy subjects.
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of Rosiglitazone and Atazanavir coadministration with and without Ritonavir. To explore the relationship between Atazanavir exposure, CYP2C8 genotype and the pharmacokinetics of Rosiglitazone exposure
Trial Locations
- Locations (1)
Local Institution
🇺🇸Hamilton, New Jersey, United States