Safety Study to Evaluate BMS-830216 in Healthy Subjects

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: BMS-830216; Drug: Placebo

• Registration Number: NCT00878020
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-07
• Study First Posted: 2009-04-08
• Study Start: 2009-05
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-11
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 5	BMS-830216	BMS-830216 (600 mg)
Arm 4	BMS-830216	BMS-830216 (300 mg)
Arm 1	Placebo	BMS-830216 (10 mg)
Arm 2	BMS-830216	BMS-830216 (30 mg)
Arm 2	Placebo	BMS-830216 (30 mg)
Arm 3	BMS-830216	BMS-830216 (100 mg)
Arm 3	Placebo	BMS-830216 (100 mg)
Arm 4	Placebo	BMS-830216 (300 mg)
Arm 5	Placebo	BMS-830216 (600 mg)
Arm 6	Placebo	BMS-830216 (1200 mg)
Arm 1	BMS-830216	BMS-830216 (10 mg)
Arm 6	BMS-830216	BMS-830216 (1200 mg)

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results	Within the 10 days after study drug administration

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ppd Development, Lp; 🇺🇸 Austin, Texas, United States