NCT02652377

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

A Randomized, Double-Blind, Pbo-Controlled, Study of EDP-494 to Evaluate the Safety and PK of SAD/FE in Healthy Subjects and MAD in Healthy and in Subjects With CHC Infection (POC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

The first phase explores single ascending doses of EDP-494 (active drug or placebo) in healthy subjects. A 'fasted' vs 'fed' two-part cohort will also assess food effect. The second phase involves multiple ascending doses (active drug or placebo) for 14 days in healthy subjects. The third, proof of concept, phase will assess two different doses for 14 days each in Hepatitis C patients. Each cohort within each phase will consist of 8 subjects randomized to either EDP-494 or placebo in a 3 to 1 ratio, with the exception of the food effect cohort, which will consist of 10 subjects randomised in a 4 to 1 ratio.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	EDP-494	10, 100 and 200 mg capsules
DRUG	Placebo	placebo to match EDP-494

Timeline

• Start date: 2016-01-10
• Primary completion: 2016-12-27
• Completion: 2016-12-27
• First posted: 2016-01-11
• Last updated: 2017-01-23

Locations

1 site across 1 country: New Zealand