A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects

Study Overview
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Brief Summary
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The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection

Official Title
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Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of BMS-650032 in Subjects Infected With Hepatitis C Virus Genotype 1

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: BMS-650032
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronically infected with HCV genotype 1 Treatment naive HCV RNA viral load of ≥10*5 IU/mL BMI 18 to 35kg/m² Exclusion Criteria: Women of childbearing potential (WOCBP) Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin HIV and/or HBV positive Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMS-650032<br> | Drug: BMS-650032<br>* Capsule, Oral, Q12h, 3/5 days Panel 1: 200 mg Panel 2: 400 mg Panel 3: 600 mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Capsule, Oral, Q 12h, 3/5 days Panel 1: matching placebo Panel 2: matching placebo Panel 3: matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline. The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 3/ or 5 |  | To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032 |  | 28 days after drug | 
| Safety Outcome Measures: Safety and tolerability assessments |  | will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 3/ or 5 days | 
| Pharmacokinetic Measures: Pharmacokinetic assessments |  | will be done on Day 1 for one dosing interval after the AM dose and on Day 3/ or 5 for 72 hours after the last AM dose |