Japanese Bridging Study Conducted in the United States

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects

Conditions
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Hepatitis C Virus

Intervention / Treatment
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* Drug: BMS-791325
* Drug: BMS-791325
* Drug: BMS-791325
* Drug: BMS-791325
* Drug: BMS-791325
* Drug: BMS-791325
* Drug: Placebo
* Drug: Placebo
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-791325 - Part A, Dose 1<br> | Drug: BMS-791325<br>* Capsules, Oral, 300 mg, Single Dose, One day<br>Drug: Placebo<br>* Capsules, Oral, Single Dose, One day<br>|
| Experimental: BMS-791325 - Part A, Dose 2<br> | Drug: BMS-791325<br>* Capsules, Oral, 900 mg, Single Dose, One day<br>Drug: Placebo<br>* Capsules, Oral, Single Dose, One day<br>|
| Experimental: BMS-791325 - Part A, Dose 3<br> | Drug: BMS-791325<br>* Capsules, Oral, ≤1200 mg, Single Dose, One day<br>Drug: Placebo<br>* Capsules, Oral, Single Dose, One day<br>|
| Experimental: BMS-791325 - Part B, Dose 1<br> | Drug: BMS-791325<br>* Capsules, Oral, 300 mg, Every 12 hours, 14 days<br>Drug: Placebo<br>* Capsules, Oral, Every 12 hours, 14 days<br>|
| Experimental: BMS-791325 - Part B, Dose 2<br> | Drug: BMS-791325<br>* Capsules, Oral, 900 mg, once daily 14 days<br>Drug: Placebo<br>* Capsules, Oral, Once Daily, 14 days<br>|
| Experimental: BMS-791325 - Part B, Dose 3<br> | Drug: BMS-791325<br>* Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days<br>Drug: Placebo<br>* Capsules, Oral, Every 12 hours or once daily, 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs) |  | From time of dose to up to 14 days after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure concentration of study drug following single and multiple doses |  | Within 48 or 72 hours postdose |