A Open-label, Drug-Drug Interaction With Maraviroc (DDI)

ViiV Healthcare112 enrolled

Overview

This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Infection, Human Immunodeficiency Virus

Interventions

BMS-663068DRUG

BMS-663068

MaravirocDRUG

Maraviroc

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 a total of 34 days post-treatment completion Exclusion Criteria: * Any condition possibly affecting drug absorption * Pre-existing liver dysfunction * Any significant acute or chronic medical illness * Orthostatic intolerance * Other protocol specified exclusion criteria could apply

Locations (1)

GSK Investigational Site

San Antonio, Texas, United States

Outcomes

Primary Outcomes

BMS-626529 Pharmacokinetics: maximum observed plasma concentration (Cmax)

PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: \- Cmax

Time frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18

BMS-626529 Pharmacokinetics: area under the plasma concentration-time curve (AUC) in a single dosing interval AUC(TAU)

PK parameters for BMS-626529 in the absence or presence of multiple doses of maraviroc include: \- AUC(TAU)

Time frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18

Maraviroc Pharmacokinetics: Cmax

PK parameters for maraviroc in the absence or presence of BMS-663068 include: \- Cmax

Time frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18

Maraviroc Pharmacokinetics: AUC(TAU)

PK parameters for maraviroc in the absence or presence of BMS-663068 include: \- AUC(TAU)

Time frame: predose and up to 12 hours post dose on Days 9, 10, 11, 16, 17, and 18

Secondary Outcomes

Other PK Parameters for BMS-626529: Time of maximum observed plasma concentration (Tmax)

PK parameters for BMS-626529 include: \- Tmax

Time frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18

Other PK Parameters for BMS-626529: plasma concentration observed at 12 hours post-dose (C12)

PK parameters for BMS-626529 include: \- C12

Time frame: predose and up to 12 hours post dose on Days 4, 16, 17, and 18

Other PK Parameters for BMS-626529: trough observed plasma concentration (Ctrough) (predose)

Data from ClinicalTrials.gov

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