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.

Study Overview

• Status: Withdrawn
• Conditions: Hepatitis C Virus
• Intervention / Treatment: Drug: BMS-791325; Drug: BMS-791325; Drug: BMS-791325; Drug: BMS-791325; Drug: BMS-791325; Drug: BMS-791325; Drug: Placebo; Drug: Placebo; Drug: Placebo; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-791325 - Part A, Dose 1	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 2	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 3	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 B, Dose 1	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 B, Dose 2	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 B, Dose 3	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs)	From time of dose to up to 14 days after last dose

Secondary Outcome Measures

Outcome Measure	Time Frame
To measure concentration of study drug following single and multiple doses	Within 48 or 72 hours postdose

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: July 27, 2009
• First Submitted That Met QC Criteria: July 27, 2009
• First Posted (Estimate): July 28, 2009

Study Record Updates

• Last Update Posted (Estimate): July 18, 2013
• Last Update Submitted That Met QC Criteria: July 17, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: AI443-011