Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone
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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
- Study Primary Completion Date: November 2006
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
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Bristol-Myers Squibb Industry
Overall Clinical Trial Officials and Contacts
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
BMS Clinical Trials Disclosure
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00362726
