Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects

Study Overview
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Brief Summary
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The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV gentotype-1 in chronically infected subjects and to further evaluate the safety profile of EDP239.

Official Title
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Double-Blind, Randomized, Placebo-controlled, Multi-center Trial to Determine the Safety and Antiviral Effect of Single Doses of EDP239 in Hepatitis C Virus (HCV) Infected Subjects

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: EDP239
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have chronic genotype-1 hepatitis C virus infection and plasma HCV-RNA ≥ 105 IU/mL at the time of screening. Subjects must have chronic HCV infection as determined by any of the following: be anti-HCV (+) for at least 6 months per subject history or medical records an anti-HCV test, viral load, or genotype > 6 months ago In the setting of a recent positive anti-HCV test (< 6 months), liver biopsy demonstrating chronicity Subjects must have IL-28b genotype CC Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2. BMI = Body weight (kg) / [Height (m)]2 Exclusion Criteria: Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days (for small molecules) whichever is longer; or longer if required by local regulations. Previous treatment, including the use of any investigational agents, for the treatment of HCV infection. Women of child bearing potential. Subjects with IL-28b genotype CT or TT. ALT γ-GT, and AST must be below 5 x the upper limit of normal (ULN). Serum bilirubin must not exceed ULN. The PT (INR) must be within normal limits. If necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error. Use of drugs that inhibit or induce CYP3A4.

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- EDP239<br>EDP239 given once a day. | Drug: EDP239<br> <br> |
| Placebo Comparator: Placebo<br>1 treatment arm will be placebo, dose given once a day. | Drug: Placebo<br> <br> |
| Experimental: 2- EDP239<br>EDP239 given once a day. | Drug: EDP239<br> <br> |
| Experimental: 3-EDP239<br>EDP239 given once a day. | Drug: EDP239<br> <br> |
| Experimental: 4-EDP239<br>EDP239 given once a day. | Drug: EDP239<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Hepatitis C viral load at Day 1 | Blood will be collected for Hepatitis C viral load at Day 1. | baseline, day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety | Laboratory and clinical evaluations will be used as safety events | 14 days | 
| Change from baseline in HCV RNA log | A viral load drop in excess of 2.5 will be considered a success. | baseline, Day 1 | 
| Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects | The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method. | baseline, day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C infected subjects