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drugset / Trial / NCT04482270

A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function

NCT04482270 ↗

Phase 1 Completed 26 enrolled Astellas Pharma Global Development, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with mild and moderate hepatic impairment compared to healthy female participants with normal hepatic function. This study will also evaluate the safety and tolerability of a single oral dose of fezolinetant in female participants with mild and moderate hepatic impairment and healthy female participants with normal hepatic function.

Timeline

Start
2020-09-02
Primary completion
2021-03-22
Completion
2021-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Fezolinetant Small molecule — Oral

Indications

No indication recorded.