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

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: NASH

Treatments: Drug: EDP 305

Study type: Interventional

Funder types: Industry

Identifiers

NCT03207425

EDP 305-003

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

29 participants in 3 patient groups

Mild hepatic impairment group

Experimental group

Treatment:

Drug: EDP 305

Moderate hepatic impairment group

Experimental group

Treatment:

Drug: EDP 305

Matching healthy control group

Experimental group

Description:

Healthy control group will be matched with the hepatically impaired population with respect to age, sex and BMI

Treatment:

Drug: EDP 305