A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)

ViiV Healthcare32 enrolled

Overview

This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase the systemic exposure of BMS-626529.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infection, Human Immunodeficiency Virus

Interventions

BMS-663068DRUG

BMS-663068

DarunavirDRUG

Darunavir

CobicistatDRUG

Cobicistat

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female * Nonsmoking subjects * Ages 18 to 50 years * Inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive * Women of childbearing potential * Must agree to follow instructions for methods of contraception for the duration of the study plus 34 days post-treatment completion Exclusion Criteria: * Any history of acute or chronic medical and surgical illness. * Personal of family history of hemophilia A or B * Other protocol defined exclusion criteria could apply

Locations (1)

GSK Investigational Site

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529

In the presence or absence of multiple doses of DRV/COBI or COBI

Time frame: predose and up to 12 hours post dose on Days 4 and 14

Data from ClinicalTrials.gov

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