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

NCT03207425 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 305-003
• Study Type: interventional
• Target: 29
• Locations: 3 countries
• Sites: 3

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.

Conditions

NASH

Keywords

Hepatic Impairment

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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

Study Arms (3)

Mild hepatic impairment group

EXPERIMENTAL

Drug: EDP 305

Moderate hepatic impairment group

EXPERIMENTAL

Drug: EDP 305

Matching healthy control group

EXPERIMENTAL

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

Drug: EDP 305

Interventions

EDP 305 DRUG

Each subject will receive a single dose of EDP 305 on Day 1.

Matching healthy control group; Mild hepatic impairment group; Moderate hepatic impairment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (3)

American Research Corporation at The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Pharmaceuticals Research Associates

Prague, Czechia

Location

Summit SRO

Bratislava, Slovakia

Location

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: June 14, 2017
• Primary Completion: September 16, 2017
• Study Completion: September 19, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-06

Locations

CZ (1); US (1); SL (1)