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