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

Completed · Phase 1

Conditions studied: Infection, Human Immunodeficiency Virus

In brief

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.

Key facts

Study ID

NCT02277600

Run by

ViiV Healthcare

People needed

32

Starts

2014-11-05

Expected to finish

2015-01-12

Last updated by the study team

2018-01-24

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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