Food Effect Study With BMS-955176

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.

Detailed Description
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Primary Purpose Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.

Official Title
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An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a 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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Inclusion Criteria: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead 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: Arm 1 (ABDC): BMS-955176<br>BMS-955176 single dose by mouth for each treatment as specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 2 (BCAD): BMS-955176<br>BMS-955176 single dose by mouth for each treatment as specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 3 (CDBA): BMS-955176<br>BMS-955176 single dose by mouth for each treatment as specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 4 (DACB): BMS-955176<br>BMS-955176 single dose by mouth for each treatment as specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 5 (EFHG): BMS-955176<br>BMS-955176 single dose by mouth for each treatment as specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 6 (FGEH): BMS-955176<br>BMS-955176 single dose by mouth for each treatment as specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 7 (GHFE): BMS-955176<br>BMS-955176 single dose by mouth for each treatment as specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 8 (HEGF): BMS-955176<br>BMS-955176 single dose by mouth for each treatment as specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 9 (IJK): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 10 (JKI): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 11 (KIJ): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 12 (IKJ): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 13 (JIK): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 14 (KJI): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 15 (LMN): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 16 (OPQ): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 17 (PQO): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 18 (QOP): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 19 (OQP): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 20 (POQ): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|
| Experimental: Arm 21 (QPO): BMS-955176<br>BMS-955176 single dose by mouth for each treatment specified | Drug: BMS-955176<br>* Single dose by mouth for each treatment specified<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) for BMS-955176 |  | Up to Day 4 of Period 4 | 
| Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176 |  | Up to Day 4 of Period 4 | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176 |  | Up to Day 4 of Period 4 | 
| Plasma concentration at 24 hours post-dose (C24) for BMS-955176 |  | Up to Day 4 of Period 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG) | Up to 30 days post discontinuation of dosing |