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A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects

NCT ID: NCT00559247

Last Updated: 2010-09-13

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/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-07-31

Brief Summary

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The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection

Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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or Placebo - Dose Panel 1

Oral Suspension, 10 mg

Group Type EXPERIMENTAL

BMS-650032 or Placebo

Intervention Type DRUG

Oral, Once daily, Single Dose

or Placebo - Dose Panel 2

Oral Suspension 50 mg

Group Type EXPERIMENTAL

BMS-650032 or Placebo

Intervention Type DRUG

Oral, Once daily, Single Dose

or Placebo - Dose Panel 3

Oral Suspension, 200 mg

Group Type EXPERIMENTAL

BMS-650032 or Placebo

Intervention Type DRUG

Oral, Once daily, Single Dose

or Placebo - Dose Panel 4

Oral Suspension or Solution, 2.5 to 600 mg

Group Type EXPERIMENTAL

BMS-650032 or Placebo

Intervention Type DRUG

Oral, Once daily, Single Dose

Interventions

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BMS-650032 or Placebo

Oral, Once daily, Single Dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronically infected with HCV genotype 1
* Treatment naive or treatment non-responders or treatment intolerant
* HCV RNA viral load of ≥10\*5 IU/mL
* BMI 18 to 35kg/m²

Exclusion Criteria

* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
* Co-infection with HIV or HBV
* Women of childbearing potential
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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West Coast Clinical Trials, Llc

Cypress, California, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Parexel International Corporation

Baltimore, Maryland, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Alamo Medical Research

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AI447-002

Identifier Type: -

Identifier Source: org_study_id