Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates

Study Overview
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Brief Summary
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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

Official Title
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Effects of BMS-955176 on the Single-dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin) in Healthy Subjects

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: CYP and transporter probe substrates
* Drug: BMS-955176
* Drug: BMS-955176 plus CYP and transporter probe substrates


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed Consent 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 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)] 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 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: Any significant acute or chronic medical illness Use of tobacco, excessive alcohol 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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single sequence, 3-period DDI (drug-drug interaction)<br>Single sequence | Drug: CYP and transporter probe substrates<br>* Cocktail of CYP (cytochrome P450) and transporter probe substrates<br>Drug: BMS-955176<br>* BMS-955176<br>Drug: BMS-955176 plus CYP and transporter probe substrates<br>* BMS-955176 plus the cocktail of CYP and transporter probe substrates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |