Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Enanta Pharmaceuticals, Inc
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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
Clareo Health | A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
