Multiple Dose Japanese Bridging Study
- Registration Number
- NCT01057030
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 22
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
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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™)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1 (BMS-708163) BMS-708163 Healthy Japanese Subjects A2 (Placebo) Placebo Healthy Japanese Subjects B2 (Placebo) Placebo Healthy Non-Japanese Subjects B1 (BMS-708163) BMS-708163 Healthy Non-Japanese Subjects
- Primary Outcome Measures
Name Time Method BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs) Every day for 28 days
- Secondary Outcome Measures
Name Time Method BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose)) Days 1, 7, and 14
Trial Locations
- Locations (1)
California Clinical Trials Medical Group
🇺🇸Glendale, California, United States