Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety, tolerability, and antiviral activity of ANA598 in patients with genotype-1 chronic hepatitis C infection.

Detailed Description
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The safety, tolerability and antiviral activity of ANA598, administered orally twice daily for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within each cohort.

Official Title
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A Phase 1, Randomized, Double-Blind, Ascending Multiple-Dose Study of the Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Chronic Hepatitis C Infection

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: ANA598 200 mg bid or placebo
* Drug: ANA598 400 mg bid or placebo
* Drug: ANA598 800 mg bid or placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, ages 18 to 65 years Documented chronic HCV infection, genotype 1a or 1b Treatment-naïve BMI = 18 - 35 kg/m2 Exclusion Criteria: Female patients who are pregnant or breast-feeding Previous treatment for HCV infection HIV or HBV positive Evidence of cirrhosis on previous liver biopsy or on previous imaging studies History of any other known cause of liver disease;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Subjects randomized 8:2 (active:placebo) to receive ANA598 200 mg bid | Drug: ANA598 200 mg bid or placebo<br>* ANA598 200 mg bid or placebo<br>|
| Experimental: Cohort 2<br>Subjects randomized 8:2 (active:placebo) to receive ANA598 400 mg bid | Drug: ANA598 400 mg bid or placebo<br>* ANA598 400 mg bid or placebo<br>|
| Experimental: Cohort 3<br>Subjects randomized 8:2 (active:placebo) to receive ANA598 800 mg bid | Drug: ANA598 800 mg bid or placebo<br>* ANA598 800 mg bid or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of ascending multiple oral doses of ANA598 administered for 3 days to adult patients with chronic HCV infection and compensated liver disease; |  | 10 days | 
| The antiviral activity of ANA598, assessed by changes in serum HCV RNA levels |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV