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Japanese Bridging Study Conducted in the United States

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00947245
First received: July 27, 2009
Last updated: July 17, 2013
Last verified: July 2013

July 27, 2009
July 17, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
20 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00947245
AI443-011
No
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