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Japanese Bridging Study Conducted in the United States

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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Recruitment Status : Withdrawn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
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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
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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
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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
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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
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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
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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
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United States, California
Local Institution
Cypress, California, United States, 90630
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site Investigator Inquiry form  This link exits the ClinicalTrials.gov site

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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:
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Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
 RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases