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

• Status: Completed
• Trial end date: 2015-01-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

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 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