NCT00947245

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2009-07-28
• Last updated: 2013-07-18

Locations

1 site across 1 country: United States