HIV Infections
Conditions
Brief summary
The purpose of the study is to study the effects of BMS-955176 on the single-dose PK parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin
Interventions
DRUGCYP and transporter probe substrates
Cocktail of CYP (cytochrome P450) and transporter probe substrates
DRUGBMS-955176
BMS-955176
DRUGBMS-955176 plus CYP and transporter probe substrates
BMS-955176 plus the cocktail of CYP and transporter probe substrates
Sponsors
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Written Informed Consent 2. Healthy male and female (not of childbearing potential) subjects as determined by medical history, surgical history, physical examination, vital signs, ECGs, and clinical laboratory determinations 3. Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/\[height(m)\] 4. Women must have documented proof that they are not of childbearing potential (eg, surgically sterile, postmenopausal with a documented follicle-stimulating hormone (FSH) \> 40 mIU/mL) and should not be breast feeding 5. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
Exclusion criteria
1. Any significant acute or chronic medical illness 2. Use of tobacco, excessive alcohol 3. Medical history indicative of an increased risk of a cardiac arrhythmia or cardiac disease and history of asthma, bronchospasm, sleep apnea, rhabdomyolysis, a bleeding disorder, a major depressive disorder within the past 6 months, peptic ulcer or significant GI bleed, Raynaud's disease, or any gastrointestinal surgery that could impact upon the absorption of study drug 4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population 5. History of allergy to BMS-955176, digoxin (or any member of the digitalis glycosides class of drugs), caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, or pravastatin, or to any related compounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax (maximum observed concentration) | Days 1 to 18 |
| AUC(0-T), area under the concentration-time curve from time zero to the time of the last quantifiable concentration | Days 1 to 18 |
| AUC(INF), area under the concentration-time curve from time zero extrapolated to infinite time | Days 1 to 18 |
Countries
United States
Outcome results
None listed