The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects...
Date First Received: August 16, 2006
Last Updated: January 7, 2009
Verified by: Bristol-Myers Squibb, January 2009
Clinical Trial Phase: Phase 1 | Start Date: April 2006
Overall Status: Completed
Estimated Enrollment: 40
Brief Summary
Official Title: “Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects”
Condition Keyword(s):
The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine 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+Ritonavir+Tenofovir
- Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.
- Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
- Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.
- Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
- Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.
- Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
- Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.
- Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine
- Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: A
- Experimental: B
- Experimental: C
- Experimental: D
- Experimental: E
Outcome Measures for this Clinical Trial
Primary Measures
- Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.
Secondary Measures
- Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.
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 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 July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00365339
Study ID Number: AI424-287
ClinicalTrials.gov Identifier: NCT00365339
Health Authority: United States: Institutional Review Board
BMS Clinical Trials Disclosure
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