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

NCT ID: NCT03207425

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-14

Study Completion Date

2017-09-19

Brief Summary

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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

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Conditions

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NASH

Keywords

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mild hepatic impairment group

Group Type EXPERIMENTAL

EDP 305

Intervention Type DRUG

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

Moderate hepatic impairment group

Group Type EXPERIMENTAL

EDP 305

Intervention Type DRUG

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

Matching healthy control group

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

Group Type EXPERIMENTAL

EDP 305

Intervention Type DRUG

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

Interventions

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EDP 305

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enanta Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Locations

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American Research Corporation at The Texas Liver Institute

San Antonio, Texas, United States

Site Status

Pharmaceuticals Research Associates

Prague, , Czechia

Site Status

Summit SRO

Bratislava, , Slovakia

Site Status

Countries

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United States Czechia Slovakia

Other Identifiers

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EDP 305-003

Identifier Type: -

Identifier Source: org_study_id