Multiple Dose Japanese Bridging Study

Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 125 mg in Healthy Japanese and Non-Japanese Subjects

The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects

Inclusion Criteria:

• Healthy Japanese and non-Japanese subjects
• Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry
• Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country
• BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects
• Men ages 20 to 45 years

Exclusion Criteria:

• Serum creatinine values above the normal range
• Urine protein or blood levels above the normal range
• Liver function tests above the normal range
• TSH, free T3, or free T4 outside the normal range
• Amylase or lipase levels above the normal range
• Positive Fecal Immunochemical Test (FIT™)