Japanese Bridging Study Conducted in the United States

Withdrawn before enrolling · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C Virus

In brief

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.

Key facts

Study ID

NCT00947245

Run by

Bristol-Myers Squibb

People needed

0

Starts

2014-10-01

Expected to finish

2015-02-01

Last updated by the study team

2013-07-18

Who can join

Age: 20 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — Cypress, California, United States

Full record on ClinicalTrials.gov

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