Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet

Study Overview
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Brief Summary
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This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of BMS-663068.

Official Title
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A Two-Part Study to Evaluate the Bioavailability of BMS-626529 Administered as Prodrug BMS-663068 From Prototype Low-Dose Extended-Release Tablets (Part 1) and Prototype Multi-Particulate Formulations (Part 2) Relative to the 600 mg Extended Release Tablet 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: Males and females, 18 to 50 years of age, inclusive Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug Exclusion Criteria: Any significant acute or chronic medical illness Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, 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: i) PR ≥ 210 msec ii) QRS ≥ 120 msec iii) QT ≥ 500 msec and iv) QTcF ≥ 450 msec Exposure to any investigational drug or placebo within 12 weeks of study drug administration Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>BMS-663068 1 × 600 mg extended-release (ER) tablet formulation | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Part 1: Prototype 1<br>BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1) | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Part 1: Prototype 2<br>BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2) | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Part 1: Prototype 3<br>BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3) | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Part 1: Prototype 4<br>BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4) | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Part 1: Prototype 5<br>BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5) | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Part 2<br>BMS-663068 1 × 600 mg ER tablet formulation | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Part 2: Prototype 1<br>BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1) | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Part 2: Prototype 2<br>BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2) | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Part 2: Prototype 3<br>BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3) | Drug: BMS-663068<br>* BMS-663068<br>|
| Experimental: Part 2: Prototype 4<br>BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4) | 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) of BMS-626529 |  | Day 1 to Day 4 of each period | 
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529 |  | Day 1 to Day 4 of each period | 
| Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529 |  | Day 1 to Day 4 of each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of BMS-663068 will be measured by incidence of Adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation;, and results of clinical laboratory tests, vital signs, 12-lead ECGs, and Physical examination (PE) |  | Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing | 
| Tolerability of BMS-663068 will be measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of clinical laboratory tests, vital signs and 12-lead ECGs |  | Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing |