Drug Interaction Study With Proton Pump Inhibitor

Bristol-Myers Squibb56 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

AtazanavirDRUG

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

Atazanavir/RitonavirDRUG

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

Atazanavir/Ritonavir+OmeprazoleDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Hamilton, New Jersey, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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