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Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant

Non-alcoholic Steatohepatitis (NASH) Clinical Trial

Official title:
A Phase 1, Open-label, Single-dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant

Clinical Trial Summary

The primary objective of this study is to determine the effect of hepatic impairment on the pharmacokinetics (PK) of miricorilant following a single oral dose by comparing participants with normal hepatic function with participants with moderate hepatic impairment with or without nonalcoholic steatohepatitis (NASH).

Clinical Trial Description

A reduced, adaptive study design will be used to compare the PK of miricorilant between participants with normal hepatic function and participants with hepatic impairment according to the Child-Pugh (CP) classification. Initially, participants with moderate hepatic impairment will be enrolled. Since indications for the development of miricorilant include participants with NASH, 3 or 4 of these participants will have NASH. Healthy control participants will be selected matched to these participants with moderate hepatic impairment according to gender, age (± 10 years), and weight (± 20 %) using a mean matching procedure. Based on the observed effect of moderate hepatic impairment on the miricorilant PK profile following an interim PK analysis, an optional group of participants with mild hepatic impairment may be evaluated. This optional group, matched to the participants with moderate hepatic impairment using the same procedure, will be enrolled to evaluate the effect of mild hepatic impairment on miricorilant PK. ;

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • Non-alcoholic Fatty Liver Disease
  • Non-alcoholic Steatohepatitis (NASH)
Clinical Trial Details
NCT number NCT05553470
Study type Interventional
Source Corcept Therapeutics
Contact Corcept Therapeutics
Phone 650-327-3270
Email clinicalstudies@corcept.com
Status Recruiting
Phase Phase 1
Start date March 3, 2022
Completion date March 31, 2024
View Details
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