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Japanese Bridging Study Conducted in the United States

NCT00947245 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2013-07-18

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00947245 on ClinicalTrials.gov