Status:
WITHDRAWN
Japanese Bridging Study Conducted in the United States
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
20-49 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00947245
Start Date
October 1 2014
End Date
February 1 2015
Last Update
July 18 2013
Active Locations (1)
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1
Local Institution
Cypress, California, United States, 90630