Japanese Bridging Study Conducted in the United States

Phase 1

Withdrawn

• Conditions: Hepatitis C Virus
• Interventions: Drug: BMS-791325; Drug: Placebo

• Registration Number: NCT00947245
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18
• Study Start: 2014-10
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-791325 - Part A, Dose 1	Placebo	-
BMS-791325 - Part A, Dose 2	BMS-791325	-
BMS-791325 - Part A, Dose 2	Placebo	-
BMS-791325 - Part A, Dose 3	Placebo	-
BMS-791325 - Part B, Dose 1	Placebo	-
BMS-791325 - Part B, Dose 2	Placebo	-
BMS-791325 - Part B, Dose 3	BMS-791325	-
BMS-791325 - Part B, Dose 3	Placebo	-
BMS-791325 - Part B, Dose 1	BMS-791325	-
BMS-791325 - Part A, Dose 3	BMS-791325	-
BMS-791325 - Part B, Dose 2	BMS-791325	-
BMS-791325 - Part A, Dose 1	BMS-791325	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Cypress, California, United States