Japanese Bridging Study Conducted in the United States

This study is not yet open for participant recruitment.

Verified February 2012 by Bristol-Myers Squibb

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00947245

First received: July 27, 2009

Last updated: June 18, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 27, 2009

Last Updated Date

June 18, 2012

Start Date ^ICMJE

February 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs) [ Time Frame: From time of dose to up to 14 days after last dose ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00947245 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To measure concentration of study drug following single and multiple doses [ Time Frame: Within 48 or 72 hours postdose ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Japanese Bridging Study Conducted in the United States

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Condition ^ICMJE

Hepatitis C Virus

Intervention ^ICMJE

Drug: BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day
Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
Drug: BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
Drug: Placebo
Capsules, Oral, Single Dose, One day
Drug: Placebo
Capsules, Oral, Every 12 hours, 14 days
Drug: Placebo
Capsules, Oral, Once Daily, 14 days
Drug: Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days

Study Arm (s)

Experimental: BMS-791325 - Part A, Dose 1
Interventions:
- Drug: BMS-791325
- Drug: Placebo
Experimental: BMS-791325 - Part A, Dose 2
Interventions:
- Drug: BMS-791325
- Drug: Placebo
Experimental: BMS-791325 - Part A, Dose 3
Interventions:
- Drug: BMS-791325
- Drug: Placebo
Experimental: BMS-791325 - Part B, Dose 1
Interventions:
- Drug: BMS-791325
- Drug: Placebo
Experimental: BMS-791325 - Part B, Dose 2
Interventions:
- Drug: BMS-791325
- Drug: Placebo
Experimental: BMS-791325 - Part B, Dose 3
Interventions:
- Drug: BMS-791325
- Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 49 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00947245

Other Study ID Numbers ^ICMJE

AI443-011

Has Data Monitoring Committee

Responsible Party

Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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