Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529

Study Overview
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Brief Summary
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The current food effect study is being performed to support a Phase 3 study with BMS 663068. Results from this study will inform whether patients in the upcoming Phase 3 study can be given the flexibility to dose BMS-663068 in the fasted state, if so desired.

Detailed Description
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Primary Purpose: Other: To assess the effect of food on the steady-state exposure of BMS-626529 when administered as BMS 663068 600 mg twice daily (BID) to healthy subjects Acquired Immune Deficiency Syndrome (AIDS)

Official Title
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Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529 From an Extended-Release Formulation of BMS-663068 in Healthy Subjects

Conditions
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Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: BMS-663068


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 and surgical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory test results Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive Males and Females, ages 18 to 50 years, inclusive Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin (HCG)) within 24 hours prior to the start of study drug Exclusion Criteria: Any significant acute or chronic medical illness as determined by the investigator Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug Any major surgery within 4 weeks of study drug administration Any gastrointestinal surgery that could impact upon the absorption of study drug Inability to tolerate oral medication Recent (within 6 months of study drug administration) history of smoking or current smokers Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations beyond what is consistent with the target population Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat: PR ≥ 210 msec QRS ≥ 120 msec QT ≥ 500 msec QTcF ≥ 450 msec Positive urine screen for drugs of abuse Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1 (HIV-1), -2 antibodies, and HIV-1 RNA

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: BMS-663068- Fasted<br>BMS-663068 tablet twice a day by mouth on specified days | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: BMS-663068- Fed<br>BMS-663068 tablet twice a day by mouth on specified days | Drug: BMS-663068<br>* BMS-663068<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) for BMS-626529 in the presence and absence of food |  | Days 1-4 of Periods 1 and 2 | 
| Area under the concentration-time curve in one dosing interval (AUC(TAU)) for BMS-626529 in the presence and absence of food |  | Days 1-4 of Periods 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability endpoints including incidence of Adverse events (AEs), serious AEs, AEs leading to discontinuations, deaths, and the results of vital signs, ECGs, physical examinations, and clinical laboratory tests |  | Approximately up to 41 days | 
| Time of maximum observed plasma concentration (Tmax) of BMS-626529 |  | Day 4 of each period | 
| Plasma concentration observed at 12 hours postdose (C12) of BMS-626529 |  | Day 4 of each period | 
| Trough observed plasma concentration (Ctrough) of BMS-626529 |  | Days 1-4 of each period |