Status:
COMPLETED
Safety Study to Evaluate BMS-830216 in Healthy Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Obesity
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00878020
Start Date
May 1 2009
End Date
September 1 2009
Last Update
February 23 2011
Active Locations (1)
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1
Ppd Development, Lp
Austin, Texas, United States, 78744