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

Phase 1

Completed

• Conditions: NASH
• Interventions: Drug: EDP 305

• Registration Number: NCT03207425
• Lead Sponsor: Enanta Pharmaceuticals, Inc

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study Start: 2017-06-14
• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-02
• Primary Completion: 2017-09-16
• Study Completion: 2017-09-19
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate hepatic impairment group	EDP 305	-
Matching healthy control group	EDP 305	Healthy control group will be matched with the hepatically impaired population with respect to age, sex and BMI
Mild hepatic impairment group	EDP 305	-

Primary Outcome Measures

Name	Time	Method
CL/F 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)
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Pharmaceuticals Research Associates; 🇨🇿 Prague, Czechia

American Research Corporation at The Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States

Summit SRO; 🇸🇰 Bratislava, Slovakia