Status:
COMPLETED
Safety Study of BMS-816336 in Healthy Male Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Diabetes Mellitus, Non-Insulin-Dependent
Dyslipidemia
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.
Eligibility Criteria
Inclusion
- Healthy male subjects
- BMI of 18 to 32 kg/m²
- Men only, ages 18-55 years
Exclusion
- Sexually active men not using effective birth control if their partners are WOCBP
- Any significant acute or chronic medical illness
- Family history of Gilbert's disease
- History of Pancreatitis
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EGG or clinical laboratory determinations
- QTc interval \> 450 msec (corrected for heart rate using Fridericia's correction method, QTcF)
- Second- or third-degree A-V block or clinically relevant ECG abnormalities
- History of allergy to 11-β-HSD-1 inhibitors or related compounds
- Prior exposure to BMS-816336
- Use of St. John's Wort (Hypericum) within 4 weeks prior to the first dose of study drug and throughout the study
- Use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration
- Use of any glucocorticoid topical creams within 4 weeks of study drug administration
- Use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00979368
Start Date
November 1 2009
End Date
February 1 2010
Last Update
February 23 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Melbourne, Victoria, Australia, 3004