ClinicalTrials.gov
ClinicalTrials.gov Menu

Japanese Bridging Study Conducted in the United States

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00947245
Recruitment Status : Withdrawn
First Posted : July 28, 2009
Last Update Posted : July 18, 2013
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: BMS-791325 Drug: Placebo Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : October 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To measure concentration of study drug following single and multiple doses [ Time Frame: Within 48 or 72 hours postdose ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947245


Locations
United States, California
Local Institution
Cypress, California, United States, 90630
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
BMS clinical trial educational resource  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

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00947245     History of Changes
Other Study ID Numbers: AI443-011
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013

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