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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03207425
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
NASH Drug: EDP 305 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : June 14, 2017
Actual Primary Completion Date : September 16, 2017
Actual Study Completion Date : September 19, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Mild hepatic impairment group Drug: EDP 305
Each subject will receive a single dose of EDP 305 on Day 1.
Experimental: Moderate hepatic impairment group Drug: EDP 305
Each subject will receive a single dose of EDP 305 on Day 1.
Experimental: Matching healthy control group
Healthy control group will be matched with the hepatically impaired population with respect to age, sex and BMI
 Drug: EDP 305
Each subject will receive a single dose of EDP 305 on Day 1.


Outcome Measures
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Primary Outcome Measures :
  1. Cmax of EDP 305 [ Time Frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10) ]
  2. AUCinf of EDP 305 [ Time Frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10) ]
  3. t1/2 of EDP 305 [ Time Frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10) ]
  4. CL/F of EDP 305 [ Time Frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10) ]

Secondary Outcome Measures :
  1. Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis). [ Time Frame: From Screening up to Day 14 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207425


Locations
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United States, Texas
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, United States, 78215
Czechia
Pharmaceuticals Research Associates
Prague, Czechia
Slovakia
Summit SRO
Bratislava, Slovakia
Sponsors and Collaborators
Enanta Pharmaceuticals
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc
More Information
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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03207425    
Other Study ID Numbers: EDP 305-003
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enanta Pharmaceuticals:
Hepatic Impairment