Clinical trial NCT01856426: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Hepatitis C infected subjects
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline Hepatitis C viral load at Day 1
timeFrame: baseline, day 1
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety
timeFrame: 14 days
measure: Change from baseline in HCV RNA log
timeFrame: baseline, Day 1
measure: Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects
timeFrame: baseline, day 1
Other outcomes:
Locations:
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: San Antonio
country: United States
facility: Investigative Site
state: Texas
city: Murray
country: United States
facility: Investigative Site
state: Utah
city: Frankfurt
country: Germany
facility: Investigative Site
city: Hamburg
country: Germany
facility: Investigative Site
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals
role: STUDY_DIRECTOR
References:
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.
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.