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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-824393
BMS-824393
BMS-824393
BMS-824393
BMS-824393
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advanced Clinical Research Institute
  • West Coast Clinical Trials, Llc
  • Elite Research Institute
  • Orlando Clinical Research Center
  • Parexel International - Baltimore Epcu
  • Alamo Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

BMS-824393 (Panel 1)

BMS-824393 (Panel 2)

BMS-824393 (Panel 3)

BMS-824393 (Panel 4)

BMS-824393 (Panel 5)

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects

Secondary Outcome Measures

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
To assess potential differences in antiviral effect in genotype subtypes (1a versus 1b)
To assess the safety and tolerability of multiple oral doses of BMS-824393

Full Information

First Posted
September 2, 2009
Last Updated
January 24, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00971308
Brief Title
Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-824393 (Panel 1)
Arm Type
Experimental
Arm Title
BMS-824393 (Panel 2)
Arm Type
Experimental
Arm Title
BMS-824393 (Panel 3)
Arm Type
Experimental
Arm Title
BMS-824393 (Panel 4)
Arm Type
Experimental
Arm Title
BMS-824393 (Panel 5)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-824393
Intervention Description
Capsule, Oral, 50mg, Once Daily, 3 days
Intervention Type
Drug
Intervention Name(s)
BMS-824393
Intervention Description
Capsule, Oral, 100mg, Once Daily, 3 days
Intervention Type
Drug
Intervention Name(s)
BMS-824393
Intervention Description
Capsule, Oral, 10mg, Once Daily, 3 days
Intervention Type
Drug
Intervention Name(s)
BMS-824393
Intervention Description
Capsule. Oral, 1mg, Once Daily, 3 days
Intervention Type
Drug
Intervention Name(s)
BMS-824393
Intervention Description
Capsule, Oral, Flexible, ≤100mg, Once Daily, 3 days
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
West Coast Clinical Trials, Llc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Elite Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Parexel International - Baltimore Epcu
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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