Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects

Bristol-Myers Squibb22 enrolled

Overview

The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100 mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in Healthy Subjects

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

HIV Infections Protease Inhibitor

Interventions

Atazanavir Sulphate + RitonavirDRUG

Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.

Atazanavir Sulphate + Ritonavir + EfavirenzDRUG

Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * BMI 18-30 * Men and women who are not of childbearing potential, ages 18-50 years, inclusive Exclusion Criteria: * History of seizures or other central nervous system disorders (including migraine headaches) * history of diagnosed mental illness or suicidal tendencies * positive screening for Hep B surface antigen * Hep C antibody * HIV-1, -2

Locations (1)

Local Institution

Hamilton, New Jersey, United States

Outcomes

Primary Outcomes

To assess the comparability of atazanavir exposure when dosed in the evening as atazanavir 400 mg with ritonavir 100 mg and with efavirenz 600 mg relative to ATV 300 mg and RTV 100 mg alone in healthy subjects

Secondary Outcomes

To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening

To assess the PK of RTV when dosed as ATV 400 mg with RTV 100 mg and with EFV 600 mg in the evening relative to ATV 300 mg with RTV 100 mg alone

To assess the safety and tolerability of ATV and RTV alone and when coadministered with EFV in the evening in healthy subjects

Data from ClinicalTrials.gov

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