Status:
COMPLETED
Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With Metformin
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the effects of Metformin administered over two weeks on the peak plasma glucose concentrations following administration of BMS-754807.
Detailed Description
Primary Purpose: Other - Protocol designed to evaluate pharmacodynamics following administration of two compounds
Eligibility Criteria
Inclusion
- Healthy male and female subjects ages 18 to 55 determined with no clinically significant deviation from normal medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory
- Women who are not of childbearing potential
Exclusion
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations consistent with a healthy volunteer target population
- History of clinically relevant hypoglycemic events
- History of clinically relevant hyperglycemic events
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01525823
Start Date
February 1 2012
End Date
April 1 2012
Last Update
June 14 2012
Active Locations (1)
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1
Local Institution
Melbourne, Victoria, Australia, 3004