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

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.

Study Overview

• Status: Completed
• Conditions: NASH
• Intervention / Treatment: Drug: EDP 305

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Pharmaceuticals Research Associates
• Slovakia
  • Bratislava, Slovakia
    • Summit SRO
• United States
  • Texas
    • San Antonio, Texas, United States, 78215
      • American Research Corporation at the Texas Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): September 16, 2017
• Study Completion (Actual): September 19, 2017

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Hepatic Impairment
• Other Study ID Numbers: EDP 305-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No