Drug Interaction Study With Proton Pump Inhibitor

April 7, 2011 updated by: Bristol-Myers Squibb

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

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 Overview

Status

Completed

Conditions

HIV Infections

Intervention / Treatment

Study Type

Interventional

Enrollment

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New Jersey
  - Hamilton, New Jersey, United States
    - Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A1	Drug: Atazanavir Capsules, Oral, 400 mg, once daily, 6 days. Other Names: Reyataz
Active Comparator: A2	Drug: Atazanavir/Ritonavir Capsules/capsules, Oral, 300/100 mg, once daily, 10 days. Other Names: Reyataz
Active Comparator: B1	Drug: Atazanavir Capsules, Oral, 400 mg, once daily, 6 days. Other Names: Reyataz
Experimental: A3 I	Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days. Other Names: Reyataz
Experimental: A3 II	Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days. Other Names: Reyataz
Active Comparator: B2	Drug: Atazanavir/Ritonavir Capsules/capsules, Oral, 300/100 mg, once daily, 10 days. Other Names: Reyataz
Experimental: B3 I	Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days. Other Names: Reyataz
Experimental: B3 II	Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days. Other Names: Reyataz Drug: Atazanavir/Ritonavir+Omeprazole Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days. Other Names: Reyataz

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
PK of ritonavir and omeprazole. Safety and tolerability of atazanavir +/- ritonavir, +/- omeprazole.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Protease inhibitor

Other Study ID Numbers

AI424-288

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interaction Study With Proton Pump Inhibitor

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Secondary Outcome Measures

Outcome Measure

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on HIV Infections

Clinical Trials on Atazanavir

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