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EDP-494-001: A Study of EDP-494 in Healthy Subjects and Hepatitis C Patients

NCT02652377 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-01-23

No results posted yet for this study

Summary

This randomized, double-blind study will assess the safety, pharmacokinetics and efficacy of a single and multiple dose(s) of orally QD administered EDP-494 in healthy volunteers (HV) and in treatment-naive subjects with GT1/3 chronic hepatitis C (CHC) infection.

Conditions

  • Hepatitis C

Interventions

DRUG

EDP-494

10, 100 and 200 mg capsules

DRUG

Placebo

placebo to match EDP-494

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Edward Gane, MD · Auckland Clinical Studies (ACS),

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-10
Primary Completion
2016-12-27
Completion
2016-12-27

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02652377 on ClinicalTrials.gov