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NCT00357240 Clinical Trial

Drug Interaction Study With Proton Pump Inhibitor

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00357240
Other study ID # AI424-288
Secondary ID
Status Completed
Phase Phase 1
First received July 25, 2006
Last updated April 7, 2011
Start date June 2006
Est. completion date August 2006

Study information
Verified date June 2008
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Atazanavir
Capsules, Oral, 400 mg, once daily, 6 days.
• Atazanavir/Ritonavir
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
• Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
• Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.
• Atazanavir
Capsules, Oral, 400 mg, once daily, 6 days.
• Atazanavir/Ritonavir
Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.
• Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.
• Atazanavir/Ritonavir+Omeprazole
Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.

Locations
Country Name City State
United States Local Institution Hamilton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.
Secondary PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.
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