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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-05

Study Completion Date

2015-01-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1, Treatment A, B

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Darunavir

Intervention Type DRUG

Darunavir

Cobicistat

Intervention Type DRUG

Cobicistat

Cohort 2, Treatment C, D

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Cobicistat

Intervention Type DRUG

Cobicistat

Interventions

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BMS-663068

Intervention Type DRUG

Darunavir

Intervention Type DRUG

Cobicistat

Intervention Type DRUG

Eligibility Criteria

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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