A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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NASH

Intervention / Treatment
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* Drug: EDP 305


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild hepatic impairment group<br> | Drug: EDP 305<br>* Each subject will receive a single dose of EDP 305 on Day 1.<br>|
| Experimental: Moderate hepatic impairment group<br> | Drug: EDP 305<br>* Each subject will receive a single dose of EDP 305 on Day 1.<br>|
| Experimental: Matching healthy control group<br>Healthy control group will be matched with the hepatically impaired population with respect to age, sex and BMI | Drug: EDP 305<br>* Each subject will receive a single dose of EDP 305 on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Impairment