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Drug Interaction Study With Proton Pump Inhibitor

NCT ID: NCT00357240

Last Updated: 2011-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A1

Group Type ACTIVE_COMPARATOR

Atazanavir

Intervention Type DRUG

Capsules, Oral, 400 mg, once daily, 6 days.

A2

Group Type ACTIVE_COMPARATOR

Atazanavir/Ritonavir

Intervention Type DRUG

Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.

A3 I

Group Type EXPERIMENTAL

Atazanavir/Ritonavir+Omeprazole

Intervention Type DRUG

Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.

A3 II

Group Type EXPERIMENTAL

Atazanavir/Ritonavir+Omeprazole

Intervention Type DRUG

Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.

B1

Group Type ACTIVE_COMPARATOR

Atazanavir

Intervention Type DRUG

Capsules, Oral, 400 mg, once daily, 6 days.

B2

Group Type ACTIVE_COMPARATOR

Atazanavir/Ritonavir

Intervention Type DRUG

Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.

B3 I

Group Type EXPERIMENTAL

Atazanavir/Ritonavir+Omeprazole

Intervention Type DRUG

Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.

B3 II

Group Type EXPERIMENTAL

Atazanavir/Ritonavir+Omeprazole

Intervention Type DRUG

Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.

Interventions

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Atazanavir

Capsules, Oral, 400 mg, once daily, 6 days.

Intervention Type DRUG

Atazanavir/Ritonavir

Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.

Intervention Type DRUG

Atazanavir/Ritonavir+Omeprazole

Capsules/capsules + Capsules, Oral, 300/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.

Intervention Type DRUG

Atazanavir/Ritonavir+Omeprazole

Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in PM + once daily in AM, 7 days.

Intervention Type DRUG

Atazanavir

Capsules, Oral, 400 mg, once daily, 6 days.

Intervention Type DRUG

Atazanavir/Ritonavir

Capsules/capsules, Oral, 300/100 mg, once daily, 10 days.

Intervention Type DRUG

Atazanavir/Ritonavir+Omeprazole

Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in AM, 7 days.

Intervention Type DRUG

Atazanavir/Ritonavir+Omeprazole

Capsules/capsules + Capsules, Oral, 400/100 mg + 20 mg, once daily in AM + once daily in PM, 7 days.

Intervention Type DRUG

Other Intervention Names

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Reyataz Reyataz Reyataz Reyataz Reyataz Reyataz Reyataz Reyataz

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Hamilton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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AI424-288

Identifier Type: -

Identifier Source: org_study_id

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