Drug Interaction Study With Proton Pump Inhibitor

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Atazanavir/Ritonavir; Drug: Atazanavir/Ritonavir+Omeprazole; Drug: Atazanavir

• Registration Number: NCT00357240
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-25
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2008-06
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2	Atazanavir/Ritonavir	-
A3 I	Atazanavir/Ritonavir+Omeprazole	-
A3 II	Atazanavir/Ritonavir+Omeprazole	-
B2	Atazanavir/Ritonavir	-
B3 I	Atazanavir/Ritonavir+Omeprazole	-
B3 II	Atazanavir/Ritonavir+Omeprazole	-
A1	Atazanavir	-
B1	Atazanavir	-

Primary Outcome Measures

Name	Time	Method
Effect of omeprazole 20 mg on PK of atazanavir (with ritonavir), coadministered or temporally separated, in healthy subjects.

Secondary Outcome Measures

Name	Time	Method
PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Hamilton, New Jersey, United States