Japanese Bridging Study Conducted in the United States

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00947245

Enrollment

Registered

2009-07-28

Start date

2014-10-31

Completion date

2015-02-28

Last updated

2013-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus

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.

Interventions

DRUGBMS-791325

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

DRUGPlacebo

Capsules, Oral, Single Dose, One day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 49 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
To measure concentration of study drug following single and multiple doses	Within 48 or 72 hours postdose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026