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

January 28, 2016 updated by: Enanta Pharmaceuticals, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • Investigative Site
      • Hamburg, Germany, 20099
        • Investigative Site
  • United States
    • Florida
      • Miami, Florida, United States, 33169
        • Investigative Site
    • Texas
      • San Antonio, Texas, United States, 78215
        • Investigative Site
    • Utah
      • Murray, Utah, United States, 84123
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1- EDP239
EDP239 given once a day.
Drug: EDP239
Placebo Comparator: Placebo
1 treatment arm will be placebo, dose given once a day.
Drug: Placebo
Experimental: 2- EDP239
EDP239 given once a day.
Drug: EDP239
Experimental: 3-EDP239
EDP239 given once a day.
Drug: EDP239
Experimental: 4-EDP239
EDP239 given once a day.
Drug: EDP239

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Hepatitis C viral load at Day 1
Time Frame: baseline, 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
Time Frame: 14 days
Laboratory and clinical evaluations will be used as safety events
14 days
Change from baseline in HCV RNA log
Time Frame: baseline, Day 1
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
Time Frame: baseline, day 1
The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method.
baseline, day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enanta Pharmaceuticals, Inc

Investigators

  • Study Director: Enanta Pharmaceuticals, Enanta Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimate)

May 17, 2013

Study Record Updates

Last Update Posted (Estimate)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEDP239X2201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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