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

Phase 1

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: BMS-824393

• Registration Number: NCT00971308
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Study Start: 2009-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-824393 (Panel 1)	BMS-824393	-
BMS-824393 (Panel 2)	BMS-824393	-
BMS-824393 (Panel 3)	BMS-824393	-
BMS-824393 (Panel 4)	BMS-824393	-
BMS-824393 (Panel 5)	BMS-824393	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Elite Research Institute; 🇺🇸 Miami, Florida, United States

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Alamo Medical Research; 🇺🇸 San Antonio, Texas, United States

Parexel International - Baltimore Epcu; 🇺🇸 Baltimore, Maryland, United States

West Coast Clinical Trials, Llc; 🇺🇸 Cypress, California, United States