Clinical trial NCT03207425: A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH
Keywords: Hepatic Impairment
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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
* 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

Primary outcomes:
measure: Cmax of EDP 305
timeFrame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
measure: AUCinf of EDP 305
timeFrame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
measure: t1/2 of EDP 305
timeFrame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
measure: CL/F of EDP 305
timeFrame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
Secondary outcomes:
measure: Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
timeFrame: From Screening up to Day 14
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: American Research Corporation at The Texas Liver Institute
state: Texas
city: Prague
country: Czechia
facility: Pharmaceuticals Research Associates
city: Bratislava
country: Slovakia
facility: Summit SRO
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: