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

NASH Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207425
• Other study ID #: EDP 305-003
• Status: Completed
• Phase: Phase 1
• First received: June 30, 2017
• Last updated: November 2, 2017
• Start date: June 14, 2017
• Est. completion date: September 19, 2017

Study information

• Verified date: June 2017
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 19, 2017
• Est. primary completion date: September 16, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• NASH

Intervention

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

Locations

Country	Name	City	State
Czechia	Pharmaceuticals Research Associates	Prague
Slovakia	Summit SRO	Bratislava
United States	American Research Corporation at The Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czechia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of EDP 305		From pre-dose on Day 1 until 216 hour post-dose (Day 10)
Primary	AUCinf of EDP 305		From pre-dose on Day 1 until 216 hour post-dose (Day 10)
Primary	t1/2 of EDP 305		From pre-dose on Day 1 until 216 hour post-dose (Day 10)
Primary	CL/F of EDP 305		From pre-dose on Day 1 until 216 hour post-dose (Day 10)
Secondary	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