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Japanese Bridging Study Conducted in the United States

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947245
First Posted: July 28, 2009
Last Update Posted: July 18, 2013
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.
Information provided by (Responsible Party):
Bristol-Myers Squibb
July 27, 2009
July 28, 2009
July 18, 2013
October 2014
February 2015   (Final data collection date for primary outcome measure)
Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs) [ Time Frame: From time of dose to up to 14 days after last dose ]
Same as current
Complete list of historical versions of study NCT00947245 on ClinicalTrials.gov Archive Site
To measure concentration of study drug following single and multiple doses [ Time Frame: Within 48 or 72 hours postdose ]
Same as current
Not Provided
Not Provided
 
Japanese Bridging Study Conducted in the United States
A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Hepatitis C Virus
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2015
February 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00947245
AI443-011
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2013

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