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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
  Purpose

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.


Condition Intervention Phase
Hepatitis C Virus
 Drug: BMS-791325
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 48
Study Start Date: February 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-791325 - Part A, Dose 1 Drug: BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
Drug: Placebo
Capsules, Oral, Single Dose, One day
Experimental: BMS-791325 - Part A, Dose 2 Drug: BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
Drug: Placebo
Capsules, Oral, Single Dose, One day
Experimental: BMS-791325 - Part A, Dose 3 Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Single Dose, One day
Drug: Placebo
Capsules, Oral, Single Dose, One day
Experimental: BMS-791325 - Part B, Dose 1 Drug: BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
Drug: Placebo
Capsules, Oral, Every 12 hours, 14 days
Experimental: BMS-791325 - Part B, Dose 2 Drug: BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
Drug: Placebo
Capsules, Oral, Once Daily, 14 days
Experimental: BMS-791325 - Part B, Dose 3 Drug: BMS-791325
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
Drug: Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days

  Eligibility

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947245

Contacts
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.

Locations
United States, California
Local Institution Not yet recruiting
Cypress, California, United States, 90630
Contact: Site 001            
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00947245     History of Changes
Other Study ID Numbers: AI443-011
Study First Received: July 27, 2009
Last Updated: June 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 23, 2013