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This study has been withdrawn prior to enrollment.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
  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:


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 ]

Enrollment: 0
Study Start Date: October 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
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: July 17, 2013
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 July 24, 2014