Safety Study of BMS-816336 in Healthy Male Subjects

Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-816336 in Healthy Male Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.

Inclusion Criteria:

• Healthy male subjects
• BMI of 18 to 32 kg/m²
• Men only, ages 18-55 years

Exclusion Criteria:

• 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