Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus

NCT ID: NCT00971308

Last Updated: 2011-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-08-31

Brief Summary

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The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.

Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-824393 (Panel 1)

Group Type EXPERIMENTAL

BMS-824393

Intervention Type DRUG

Capsule, Oral, 50mg, Once Daily, 3 days

BMS-824393 (Panel 2)

Group Type EXPERIMENTAL

BMS-824393

Intervention Type DRUG

Capsule, Oral, 100mg, Once Daily, 3 days

BMS-824393 (Panel 3)

Group Type EXPERIMENTAL

BMS-824393

Intervention Type DRUG

Capsule, Oral, 10mg, Once Daily, 3 days

BMS-824393 (Panel 4)

Group Type EXPERIMENTAL

BMS-824393

Intervention Type DRUG

Capsule. Oral, 1mg, Once Daily, 3 days

BMS-824393 (Panel 5)

Group Type EXPERIMENTAL

BMS-824393

Intervention Type DRUG

Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days

Interventions

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BMS-824393

Capsule, Oral, 50mg, Once Daily, 3 days

Intervention Type DRUG

BMS-824393

Capsule, Oral, 100mg, Once Daily, 3 days

Intervention Type DRUG

BMS-824393

Capsule, Oral, 10mg, Once Daily, 3 days

Intervention Type DRUG

BMS-824393

Capsule. Oral, 1mg, Once Daily, 3 days

Intervention Type DRUG

BMS-824393

Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Treatment naive chronically infected subjects with Hepatitis C Virus genotype 1
* HCV RNA viral load of ≤10\*5\* IU/mL (100,000 IU/mL)
* Body Mass Index (BMI) of 18 to 35 kg/m², inclusive

Exclusion Criteria

* Women who are pregnant or breast feeding
* Any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with Hepatitis C infection
* Any other medical, psychiatric and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Advanced Clinical Research Institute

Anaheim, California, United States

Site Status

West Coast Clinical Trials, Llc

Cypress, California, United States

Site Status

Elite Research Institute

Miami, Florida, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Parexel International - Baltimore Epcu

Baltimore, Maryland, United States

Site Status

Alamo Medical Research

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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AI451-002

Identifier Type: -

Identifier Source: org_study_id

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