Japanese Bridging Study Conducted in the United States

• Status: Withdrawn
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.

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

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Inclusion Criteria:

• Healthy male and female subjects aged 20 to 49 years, with BMI of 18-30 kg/m2

• First generation Japanese. Subject born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry

Exclusion Criteria:

• Any significant acute or chronic medical illness.

• Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.

• Gastrointestinal disease that may impact the absorption of study drug or that required treatment with a protocon inhibitor, antacid or H2 blocker.

• History of eczema, psoriasis, or any intermittent or active dermatitis.

• Positive for HIV or HCV