A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection

Official Title
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Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-791325 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: BMS-791325
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronically infected with HCV genotype 1 Treatment naive or treatment non-responders or treatment intolerant HCV RNA viral load of ≥10*5* IU/mL BMI 18 to 35 kg/m² Exclusion Criteria: Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug Co-infection with HIV or HBV

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>BMS-791325 (100 mg) or placebo match for (100 mg) | Drug: BMS-791325<br>* Capsules, Oral, Once Daily, Single Dose<br>Drug: Placebo<br>* Capsules, Oral, Once Daily, Single Dose<br>|
| Experimental: 2<br>BMS-791325 (300 mg) or placebo match for (300 mg) | Drug: BMS-791325<br>* Capsules, Oral, Once Daily, Single Dose<br>Drug: Placebo<br>* Capsules, Oral, Once Daily, Single Dose<br>|
| Experimental: 3<br>BMS-791325 (900 mg) or placebo match for (900 mg) | Drug: BMS-791325<br>* Capsules, Oral, Once Daily, Single Dose<br>Drug: Placebo<br>* Capsules, Oral, Once Daily, Single Dose<br>|
| Experimental: 4<br>BMS-791325 (potential dose between 10-800 mg) or placebo match for (10-800 mg) | Drug: BMS-791325<br>* Capsules, Oral, Once Daily, Single Dose<br>Drug: Placebo<br>* Capsules, Oral, Once Daily, Single Dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Outcome Measures |  | Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Measures |  | Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose | 
| Pharmacodynamic Measures |  | Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing |