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

January 24, 2011 updated by: Bristol-Myers Squibb

Open Label, Multiple-Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of BMS-824393 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • 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
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Cypress, California, United States, 90630
        • West Coast Clinical Trials, Llc
    • Florida
      • Miami, Florida, United States, 33169
        • Elite Research Institute
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • Parexel International - Baltimore Epcu
    • 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:

  • 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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-824393 (Panel 1)
Drug: BMS-824393
Capsule, Oral, 50mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, 100mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, 10mg, Once Daily, 3 days
Drug: BMS-824393
Capsule. Oral, 1mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days
Experimental: BMS-824393 (Panel 2)
Drug: BMS-824393
Capsule, Oral, 50mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, 100mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, 10mg, Once Daily, 3 days
Drug: BMS-824393
Capsule. Oral, 1mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days
Experimental: BMS-824393 (Panel 3)
Drug: BMS-824393
Capsule, Oral, 50mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, 100mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, 10mg, Once Daily, 3 days
Drug: BMS-824393
Capsule. Oral, 1mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days
Experimental: BMS-824393 (Panel 4)
Drug: BMS-824393
Capsule, Oral, 50mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, 100mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, 10mg, Once Daily, 3 days
Drug: BMS-824393
Capsule. Oral, 1mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days
Experimental: BMS-824393 (Panel 5)
Drug: BMS-824393
Capsule, Oral, 50mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, 100mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, 10mg, Once Daily, 3 days
Drug: BMS-824393
Capsule. Oral, 1mg, Once Daily, 3 days
Drug: BMS-824393
Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects
Time Frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the change in HCV RNA over time during three days of dosing with BMS- 824393 and during the follow-up period in chronically genotype subtype 1a and 1b HCV infected subjects
Time Frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
To assess potential differences in antiviral effect in genotype subtypes (1a versus 1b)
Time Frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
To assess the safety and tolerability of multiple oral doses of BMS-824393
Time Frame: On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration

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

October 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI451-002

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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