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
Overview
- Phase
- Phase 1
- Intervention
- BMS-830216
- Conditions
- Obesity
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm 5
BMS-830216 (600 mg)
Intervention: BMS-830216
Arm 1
BMS-830216 (10 mg)
Intervention: BMS-830216
Arm 1
BMS-830216 (10 mg)
Intervention: Placebo
Arm 2
BMS-830216 (30 mg)
Intervention: BMS-830216
Arm 2
BMS-830216 (30 mg)
Intervention: Placebo
Arm 3
BMS-830216 (100 mg)
Intervention: BMS-830216
Arm 3
BMS-830216 (100 mg)
Intervention: Placebo
Arm 4
BMS-830216 (300 mg)
Intervention: BMS-830216
Arm 4
BMS-830216 (300 mg)
Intervention: Placebo
Arm 5
BMS-830216 (600 mg)
Intervention: Placebo
Arm 6
BMS-830216 (1200 mg)
Intervention: BMS-830216
Arm 6
BMS-830216 (1200 mg)
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results
Time Frame: Within the 10 days after study drug administration
Secondary Outcomes
- 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)