NCT04476849

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

A Phase 1 Open-label Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of Fezolinetant Compared to Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will be comprised of four groups of participants based on renal function. Participants will be screened for up to 28 days prior to investigational product (IP) administration on Day 1. Eligible participants with mild, moderate and severe renal function and healthy participants with normal renal function will be admitted to the clinical unit on Day -1 and will be residential for a single period of six days/five nights. On Day 1, participants will receive a single oral dose of fezolinetant under fasting conditions followed by a 96-hour in-house blood and urine sampling period. Participants are to remain awake, seated or semirecumbent and avoid lying on either the left or right side for at least four hours postdose. Standard safety and tolerability assessments will be conducted. Participants will be discharged from the clinical unit on Day 5 on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit. The study will be completed with an end-of-study visit (ESV). The ESV will take place five to nine days after the last pharmacokinetic sample is collected or at early discontinuation from the study.

Conditions

• Healthy Volunteers
• Renal Impairment

Interventions

Type	Name	Description
DRUG	fezolinetant	Oral

Timeline

• Start date: 2020-08-10
• Primary completion: 2022-03-06
• Completion: 2022-03-11
• First posted: 2020-07-20
• Last updated: 2024-10-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study