The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects...
Date First Received: July 25, 2006
Last Updated: June 27, 2008
Verified by: Bristol-Myers Squibb, June 2008
Clinical Trial Phase: Phase 1 | Start Date: June 2006
Overall Status: Completed
Estimated Enrollment: 56
Brief Summary
Official Title: “Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Omeprazole 20 mg on the Pharmacokinetics of Atazanavir Administered With Ritonavir in Healthy Subjects”
Condition Keyword(s):
The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.
Study Type: Interventional
Study Design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Intervention(s) in this Clinical Trial
- Drug: Atazanavir
- Capsules, Oral, 400 mg, once daily, 6 days.
- Drug: Atazanavir/Ritonavir
- Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
- Drug: Atazanavir/Ritonavir+Omeprazole
- Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
- Drug: Atazanavir/Ritonavir+Omeprazole
- Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
- Drug: Atazanavir
- Capsules, Oral, 400 mg, once daily, 6 days.
- Drug: Atazanavir/Ritonavir
- Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
- Drug: Atazanavir/Ritonavir+Omeprazole
- Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.
- Drug: Atazanavir/Ritonavir+Omeprazole
- Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: A1
- Active Comparator: A2
- Experimental: A3 I
- Experimental: A3 II
- Active Comparator: B1
- Active Comparator: B2
- Experimental: B3 I
- Experimental: B3 II
Outcome Measures for this Clinical Trial
Primary Measures
- Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.
Secondary Measures
- PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy male and female subjects between the ages of 18 to 50 years old with 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 Sponsor Information
Lead Sponsor: Bristol-Myers Squibb
Overall Clinical Trial Officials and Contacts
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00357240
Study ID Number: AI424-288
ClinicalTrials.gov Identifier: NCT00357240
Health Authority: United States: Food and Drug Administration
BMS Clinical Trials Disclosure
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Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
