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Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

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: April 7, 2011

Page last updated: August 23, 2015

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