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

• Status: Recruiting
• Trial end date: 2021-10-31

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 varying levels of renal impairment (mild, moderate and severe) compared to healthy female participants with normal renal function.

This study will also evaluate the safety and tolerability of a single oral dose of fezolinetant in female participants with varying levels of renal impairment (mild, moderate and severe) and healthy female participants with normal renal function.

Renal function will be measured by estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula: Mild (eGFR 60 to < 90 mL/min per 1.73 m^2) renal impairment; moderate (eGFR 30 to < 60 mL/min per 1.73 m^2) renal impairment, severe (eGFR < 30 mL/min per 1.73 m^2) renal impairment and not on hemodialysis and normal (eGFR ≥ 90 mL/min per 1.73 m^2) renal function.

• Phase: Phase 1

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.