Clinical Trials/NCT03207425

NCT03207425

Completed

Phase 1

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

Enanta Pharmaceuticals, Inc3 sites in 3 countries29 target enrollmentJune 14, 2017

ConditionsNASH

InterventionsEDP 305

DrugsEDP 305

Overview

Phase: Phase 1
Intervention: EDP 305
Conditions: NASH
Sponsor: Enanta Pharmaceuticals, Inc
Enrollment: 29
Locations: 3
Primary Endpoint: Cmax of EDP 305
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 14, 2017

End Date

September 19, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Enanta Pharmaceuticals, Inc

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Mild hepatic impairment group

Intervention: EDP 305

Moderate hepatic impairment group

Intervention: EDP 305

Matching healthy control group

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

Intervention: EDP 305

Outcomes

Primary Outcomes

Cmax of EDP 305

Time Frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)

AUCinf of EDP 305

Time Frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)

t1/2 of EDP 305

Time Frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)

CL/F of EDP 305

Time Frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)

Secondary Outcomes

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)