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

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: Maraviroc; Drug: BMS-663068

Study type: Interventional

Funder types: Industry

Identifiers

NCT02480894

AI438-052 (Other Identifier)

206278

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Sequential Dosing

Experimental group

Description:

Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: Maraviroc BID on Days 7 through 11 Treatment C: BMS-663068 BID plus maraviroc BID on Days 12 through 18

Treatment:

Drug: BMS-663068

Drug: Maraviroc