Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus
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
1 other identifier
interventional
37
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2009
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJanuary 25, 2011
January 1, 2011
10 months
September 2, 2009
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in HCV RNA following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b HCV infected subjects
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
Secondary Outcomes (3)
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
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)
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
On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration
Study Arms (5)
BMS-824393 (Panel 1)
EXPERIMENTALBMS-824393 (Panel 2)
EXPERIMENTALBMS-824393 (Panel 3)
EXPERIMENTALBMS-824393 (Panel 4)
EXPERIMENTALBMS-824393 (Panel 5)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
West Coast Clinical Trials, Llc
Cypress, California, 90630, United States
Elite Research Institute
Miami, Florida, 33169, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Parexel International - Baltimore Epcu
Baltimore, Maryland, 21225, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 3, 2009
Study Start
October 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
January 25, 2011
Record last verified: 2011-01