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

Completed · Phase 1

Conditions studied: NASH

In brief

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.

Key facts

Study ID

NCT03207425

Run by

Enanta Pharmaceuticals, Inc

People needed

29

Starts

2017-06-14

Expected to finish

2017-09-19

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• American Research Corporation at The Texas Liver Institute — San Antonio, Texas, United States
• Pharmaceuticals Research Associates — Prague, Czechia
• Summit SRO — Bratislava, Slovakia

Full record on ClinicalTrials.gov

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