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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: BMS-824393
* Drug: BMS-824393
* Drug: BMS-824393
* Drug: BMS-824393
* Drug: BMS-824393


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | On Days 1, 2, 3, 4, 5, 6, 7, 14, 28, 90 and 180 days after study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 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 |