Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Rosiglitazone maleate (Drug); Atazanavir Sulphate (Drug); Atazanavir Sulphate + Rosiglitazone maleate (Drug); Atazanavir Sulphate + Ritonavir (Drug); Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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.
Clinical Details
Official title: Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects
Study design: Other, Non-Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: 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: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to
32 kg/m2
Locations and Contacts
Local Institution, Hamilton, New Jersey, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: September 2006
Last updated: June 11, 2008
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