Official Title: “Effect of Atazanavir Administered With and Without Ritonavir on the Pharmacokinetics of the Cytochrome P450 2C8 Substrate Rosiglitazone in Healthy Subjects”

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

Study Design: Other, Non-Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: Rosiglitazone maleate
  • Tablets, Oral, RGZ 4 mg, once daily, 1 day.
• Drug: Atazanavir Sulphate
  • Capsules, Oral, ATV 400 mg, once daily, 5 days.
• Drug: Atazanavir Sulphate + Rosiglitazone maleate
  • Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.
• Drug: Atazanavir Sulphate + Ritonavir
  • Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.
• Drug: Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate
  • Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B
• Active Comparator: C
• Active Comparator: D
• Active Comparator: E

Primary Measures

• 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 Measures

• 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

Inclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00362726

Study ID Number: AI424-106

ClinicalTrials.gov Identifier: NCT00362726

Health Authority: United States: Food and Drug Administration

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