Infection, Human Immunodeficiency Virus
Conditions
Brief 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.
Interventions
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529 | predose and up to 12 hours post dose on Days 4 and 14 | In the presence or absence of multiple doses of DRV/COBI or COBI |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by adverse events and other physical parameters | From dosing (Day 1) to Day 14 | Collection of adverse events and other physical parameters to assess safety and tolerability |
Countries
United States
Outcome results
None listed