Multiple Dose Japanese Bridging Study

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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

Key facts

Study ID

NCT01057030

Run by

Bristol-Myers Squibb

People needed

22

Starts

2010-03-01

Expected to finish

2010-06-01

Last updated by the study team

2011-01-25

Who can join

Age: 20 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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™)

Where it is running

• California Clinical Trials Medical Group — Glendale, California, United States

Full record on ClinicalTrials.gov

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