Japanese Bridging Study Conducted in the United States
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 20 - 49 |
| Updated: | 7/16/2013 |
| Start Date: | February 2013 |
| End Date: | June 2013 |
| Contact: | For participation information at a USA site use a phone number below. For site information outside the USA please email: |
| Email: | Clinical.Trials@bms.com |
A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects
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.
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
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