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

Bristol-Myers Squibb14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Rosiglitazone maleateDRUG

Tablets, Oral, RGZ 4 mg, once daily, 1 day.

Atazanavir SulphateDRUG

Capsules, Oral, ATV 400 mg, once daily, 5 days.

Atazanavir Sulphate + Rosiglitazone maleateDRUG

Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Locations (1)

Local Institution

Hamilton, New Jersey, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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