Japanese Bridging Study Conducted in the United States

Bristol-Myers Squibb

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Conditions

Hepatitis C Virus

Interventions

BMS-791325DRUG

Capsules, Oral, 300 mg, Single Dose, One day

BMS-791325DRUG

Capsules, Oral, 900 mg, Single Dose, One day

BMS-791325DRUG

Capsules, Oral, ≤1200 mg, Single Dose, One day

BMS-791325

Eligibility

Sex: ALLMin age: 20 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Cypress, California, United States

Outcomes

Primary Outcomes

Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs)

Time frame: From time of dose to up to 14 days after last dose

Secondary Outcomes

To measure concentration of study drug following single and multiple doses

Time frame: Within 48 or 72 hours postdose

Data from ClinicalTrials.gov

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