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

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: Cobicistat; Drug: BMS-663068; Drug: Darunavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02277600

AI438-044 (Other Identifier)

206285

Details and patient eligibility

About

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.

Enrollment: 32 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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

Cohort 1, Treatment A, B

Experimental group

Description:

Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14

Treatment:

Drug: BMS-663068

Drug: Cobicistat

Drug: Darunavir

Cohort 2, Treatment C, D

Experimental group

Description:

Treatment C: BMS-663068 orally BID on Days 1 through 4 Treatment D: BMS-663068 orally BID plus COBI QD on Days 5 through 14

Treatment:

Drug: BMS-663068

Drug: Cobicistat