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

September 10, 2010 updated by: Bristol-Myers Squibb

Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-650032 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • West Coast Clinical Trials, Llc
    • Florida
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • Parexel International Corporation
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Texas
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: or Placebo - Dose Panel 1
Oral Suspension, 10 mg
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
Experimental: or Placebo - Dose Panel 2
Oral Suspension 50 mg
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
Experimental: or Placebo - Dose Panel 3
Oral Suspension, 200 mg
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose
Experimental: or Placebo - Dose Panel 4
Oral Suspension or Solution, 2.5 to 600 mg
Drug: BMS-650032 or Placebo
Oral, Once daily, Single Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Outcome Measures
Time Frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose
Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic Measures
Time Frame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose
Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose
Pharmacodynamic Measures
Time Frame: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing
Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

September 13, 2010

Last Update Submitted That Met QC Criteria

September 10, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI447-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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