Hepatitis C
Conditions
Keywords
Hepatitis C infected subjects
Brief summary
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.
Interventions
DRUGEDP239
DRUGPlacebo
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Hepatitis C viral load at Day 1 | baseline, day 1 | Blood will be collected for Hepatitis C viral load at Day 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as a measure of safety | 14 days | Laboratory and clinical evaluations will be used as safety events |
| Change from baseline in HCV RNA log | baseline, Day 1 | A viral load drop in excess of 2.5 will be considered a success. |
| Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects | baseline, day 1 | The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method. |
Countries
Germany, United States
Outcome results
None listed