Relative Bioavailability Study With BMS-955176

Study Overview
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Brief Summary
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The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.

Detailed Description
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Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed

Official Title
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Assessment of BMS-955176 Bioavailability From a Micronized Crystalline Tablet Relative to a Spray-Dried Dispersion Suspension and Assessment of Additional Experimental Formulations Relative to the Micronized Crystalline Tablet in Healthy Subjects

Conditions
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Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: BMS-955176


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG) measurements and clinical laboratory test results Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg) / [height (m)]2 Men and women, ages 18 to 50 years, inclusive Women must not be of childbearing potential, must not be breastfeeding Exclusion Criteria: Any significant acute or chronic medical illness History of cardiac disease or clinically significant cardiac arrhythmias Current or recent (within 3 months of study drug administration) gastrointestinal disease Any major surgery within 4 weeks of study drug administration Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C)<br>BMS-955176 single dose by mouth as specified | Drug: BMS-955176<br>* BMS-955176<br>|
| Experimental: Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A)<br>BMS-955176 single dose by mouth as specified | Drug: BMS-955176<br>* BMS-955176<br>|
| Experimental: Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C)<br>BMS-955176 single dose by mouth as specified | Drug: BMS-955176<br>* BMS-955176<br>|
| Experimental: Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B)<br>BMS-955176 single dose by mouth as specified | Drug: BMS-955176<br>* BMS-955176<br>|
| Experimental: Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H)<br>BMS-955176 single dose by mouth as specified | Drug: BMS-955176<br>* BMS-955176<br>|
| Experimental: Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E)<br>BMS-955176 single dose by mouth as specified | Drug: BMS-955176<br>* BMS-955176<br>|
| Experimental: Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G)<br>BMS-955176 single dose by mouth as specified | Drug: BMS-955176<br>* BMS-955176<br>|
| Experimental: Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F)<br>BMS-955176 single dose by mouth as specified | Drug: BMS-955176<br>* BMS-955176<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of BMS-955176 |  | Days 1-4 of Periods 1, 2, 3 and 4 | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176 |  | Days 1-4 of Periods 1, 2, 3 and 4 | 
| Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176 |  | Days 1-4 of Periods 1, 2, 3 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum observed plasma concentration (Tmax) of BMS-955176 |  | Days 1-4 of Periods 1, 2, 3 and 4 | 
| Terminal plasma half-life (T-HALF) of BMS-955176 |  | Days 1-4 of Periods 1, 2, 3 and 4 | 
| Apparent total body clearance (CLT/F) of BMS-955176 |  | Days 1-4 of Periods 1, 2, 3 and 4 | 
| Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations |  | Up to Period 4/Day 4 (discharge) |