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

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

EDP239

Placebo

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C infected subjects

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigative Site
Investigative Site
Investigative Site
Investigative Site
Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

1- EDP239

Placebo

2- EDP239

3-EDP239

4-EDP239

Arm Description

EDP239 given once a day.

1 treatment arm will be placebo, dose given once a day.

EDP239 given once a day.

Outcomes

Primary Outcome Measures

Change from baseline Hepatitis C viral load at Day 1

Blood will be collected for Hepatitis C viral load at Day 1.

Secondary Outcome Measures

Number of participants with adverse events as a measure of safety

Laboratory and clinical evaluations will be used as safety events

Change from baseline in HCV RNA log

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

The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method.

Full Information

NCT ID

NCT01856426

First Posted

May 14, 2013

Last Updated

January 28, 2016

Sponsor

Enanta Pharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT01856426

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Enanta Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Hepatitis C infected subjects

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1- EDP239

Arm Type

Experimental

Arm Description

EDP239 given once a day.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

1 treatment arm will be placebo, dose given once a day.

Arm Title

2- EDP239

Arm Type

Experimental

Arm Description

EDP239 given once a day.

Arm Title

3-EDP239

Arm Type

Experimental

Arm Description

EDP239 given once a day.

Arm Title

4-EDP239

Arm Type

Experimental

Arm Description

EDP239 given once a day.

Intervention Type

Drug

Intervention Name(s)

EDP239

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change from baseline Hepatitis C viral load at Day 1

Description

Blood will be collected for Hepatitis C viral load at Day 1.

Time Frame

baseline, day 1

Secondary Outcome Measure Information:

Title

Number of participants with adverse events as a measure of safety

Description

Laboratory and clinical evaluations will be used as safety events

Time Frame

14 days

Title

Change from baseline in HCV RNA log

Description

A viral load drop in excess of 2.5 will be considered a success.

Time Frame

baseline, Day 1

Title

Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects

Description

The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method.

Time Frame

baseline, day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enanta Pharmaceuticals

Organizational Affiliation

Enanta Pharmaceuticals, Inc

Official's Role

Study Director

Facility Information:

Facility Name

Investigative Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Investigative Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

Facility Name

Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Investigative Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

27503644

Citation

Owens CM, Brasher BB, Polemeropoulos A, Rhodin MH, McAllister N, Wong KA, Jones CT, Jiang L, Lin K, Or YS. Preclinical and Clinical Resistance Profile of EDP-239, a Novel Hepatitis C Virus NS5A Inhibitor. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6216-26. doi: 10.1128/AAC.00815-16. Print 2016 Oct.

Results Reference

derived

PubMed Identifier

27503640

Citation

Owens CM, Brasher BB, Polemeropoulos A, Rhodin MH, McAllister N, Peng X, Wang C, Ying L, Cao H, Lawitz E, Poordad F, Rondon J, Box TD, Zeuzem S, Buggisch P, Lin K, Qiu YL, Jiang L, Colvin R, Or YS. Preclinical Profile and Clinical Efficacy of a Novel Hepatitis C Virus NS5A Inhibitor, EDP-239. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6207-15. doi: 10.1128/AAC.00808-16. Print 2016 Oct.

Results Reference

derived

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

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