Safety Study to Evaluate BMS-830216 in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety profile, tolerability, and pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of BMS-819881) in healthy subjects

Official Title
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Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-830216 (Pro-Drug of BMS-819881) in Healthy Subjects

Conditions
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Obesity

Intervention / Treatment
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* Drug: BMS-830216
* Drug: Placebo
* Drug: BMS-830216
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men between ages of 18 to 45 Exclusion Criteria: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>BMS-830216 (10 mg) | Drug: BMS-830216<br>* Capsules, Oral, Single Dose, 1 day<br>Drug: Placebo<br>* Capsules, Oral, 0mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 2<br>BMS-830216 (30 mg) | Drug: BMS-830216<br>* Capsules, Oral, Single Dose, 1 day<br>Drug: Placebo<br>* Capsules, Oral, 0mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 3<br>BMS-830216 (100 mg) | Drug: BMS-830216<br>* Capsules, Oral, Single Dose, 1 day<br>Drug: Placebo<br>* Capsules, Oral, 0mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 4<br>BMS-830216 (300 mg) | Drug: BMS-830216<br>* Capsules, Oral, Single Dose on Day 1, Period 1 and Day 1, Period 2, 2 days<br>Drug: Placebo<br>* Capsules, Oral, 0mg, Single Dose, on Day 1, Period 1 and Day 1, Period 2, 2 days<br>|
| Active Comparator: Arm 5<br>BMS-830216 (600 mg) | Drug: BMS-830216<br>* Capsules, Oral, Single Dose, 1 day<br>Drug: Placebo<br>* Capsules, Oral, 0mg, Single Dose, 1 day<br>|
| Active Comparator: Arm 6<br>BMS-830216 (1200 mg) | Drug: BMS-830216<br>* Capsules, Oral, Single Dose, 1 day<br>Drug: Placebo<br>* Capsules, Oral, 0mg, Single Dose, 1 day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results |  | Within the 10 days after study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile (drug absorption, distribution, metabolism and excretion process) determined by plasma concentration vs. time profile from a series of plasma samples up to 10 days post dose |  | Within the 10 days after study drug administration |