Trials / Completed
CompletedNCT03207425
A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
A Phase 1, Open-Label, Parallel Group, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of EDP 305 in Subjects With Varying Degrees of Hepatic Function
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Enanta Pharmaceuticals, Inc · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EDP 305 | Each subject will receive a single dose of EDP 305 on Day 1. |
Timeline
- Start date
- 2017-06-14
- Primary completion
- 2017-09-16
- Completion
- 2017-09-19
- First posted
- 2017-07-02
- Last updated
- 2017-11-06
Locations
3 sites across 3 countries: United States, Czechia, Slovakia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03207425. Inclusion in this directory is not an endorsement.