DDI HV (ATV - Merck)

Bristol-Myers Squibb22 enrolled

Overview

The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

RaltegravirDRUG

Tablet, Oral, 400 mg, twice daily for 5 Days

AtazanavirDRUG

Capsule, Oral, 300 mg, twice daily for 7 Days

Atazanavir + RaltegravirDRUG

Capsule/Tablet, Oral, 300/400, twice daily for 14 Days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m² * Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test Exclusion Criteria: * Any significant acute or chronic medical illness * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations. * Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration * Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration

Locations (1)

Bristol-Myers Squibb Clinical Pharmacology Unit

Hamilton, New Jersey, United States

Outcomes

Primary Outcomes

Safety Assessments

Time frame: Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge

Pharmacokinetic Assessments

Time frame: Days 5, 12, and 26

Data from ClinicalTrials.gov

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