Japanese Bridging Study Conducted in the United States

Hepatitis C Virus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00947245
• Other study ID #: AI443-011
• Status: Withdrawn
• Phase: Phase 1
• First received: July 27, 2009
• Last updated: July 17, 2013
• Start date: October 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• BMS-791325
Capsules, Oral, 300 mg, Single Dose, One day
• BMS-791325
Capsules, Oral, 900 mg, Single Dose, One day
• BMS-791325
Capsules, Oral, =1200 mg, Single Dose, One day
• BMS-791325
Capsules, Oral, 300 mg, Every 12 hours, 14 days
• BMS-791325
Capsules, Oral, 900 mg, once daily 14 days
• BMS-791325
Capsules, Oral, =1200 mg, Every 12 hours or once daily, 14 days
• Placebo
Capsules, Oral, Single Dose, One day
• Placebo
Capsules, Oral, Every 12 hours, 14 days
• Placebo
Capsules, Oral, Once Daily, 14 days
• Placebo
Capsules, Oral, Every 12 hours or once daily, 14 days

Locations

Country	Name	City	State
United States	Local Institution	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs)		From time of dose to up to 14 days after last dose	Yes
Secondary	To measure concentration of study drug following single and multiple doses		Within 48 or 72 hours postdose	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form