Safety Study of BMS-816336 in Healthy Male Subjects

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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