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

• Status: Completed
• Trial end date: 2015-09-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb; ViiV Healthcare
• Collaborator: GlaxoSmithKline
• Treatments: Fostemsavir; Maraviroc

Criteria

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