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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03207425

Enrollment

Registered

2017-07-02

Start date

2017-06-14

Completion date

2017-09-19

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASH

Keywords

Hepatic Impairment

Brief 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.

Interventions

DRUGEDP 305

Each subject will receive a single dose of EDP 305 on Day 1.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Able to understand and willing to sign the ICF and able to comply with the study restrictions * Adult male or female subjects age 18 to 75 years, inclusive, at the time of informed consent * Female subjects must be non-childbearing potential Additional criteria for hepatically impaired subjects * Confirmed diagnosis of cirrhosis due to parenchymal liver disease * Stable hepatic impairment, defined as no clinically significant change in disease status, as judged by the Investigator

Exclusion criteria

* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at Screening that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer except for conditions associated with hepatic impairment in subjects with compromised hepatic function * Clinically significant renal disease Additional criteria for hepatically impaired Subjects * History of esophageal bleeding within the last 3 months prior to study drug administration * Severe hepatic encephalopathy (Grade \>2) or degree of central nervous system (CNS) impairment * History of liver transplantation * Presence of Hepatocellular Carcinoma, or suspicion of Hepatocellular Carcinoma based on Investigator's judgment * Hepato-renal or hepato-pulmonary syndrome * Prior placement of a portosystemic shunt * Spontaneous bacterial peritonitis currently or within the last 6 months * Hospitalization within the last 2 months related to cirrhosis * Advanced ascites and ascites which require emptying and albumin supplementation, as judged by the Investigator * Hemoglobin concentration \< 10.0 g/dL

Design outcomes

Primary

Measure	Time frame
Cmax of EDP 305	From pre-dose on Day 1 until 216 hour post-dose (Day 10)
AUCinf of EDP 305	From pre-dose on Day 1 until 216 hour post-dose (Day 10)
t1/2 of EDP 305	From pre-dose on Day 1 until 216 hour post-dose (Day 10)
CL/F of EDP 305	From pre-dose on Day 1 until 216 hour post-dose (Day 10)

Secondary

Measure	Time frame
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).	From Screening up to Day 14

Countries

Czechia, Slovakia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026