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Selective Estrogen Receptor Modulator

Fezolinetant: Normal Hepatic Function for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 days
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Liver disease
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PK of Fezolinetant Metabolite ES259564 in Plasma: AUCinf
PK of Fezolinetant Metabolite ES259564 in Plasma: AUClast
PK of Fezolinetant Metabolite ES259564 in Plasma: Cmax
+5 more
Secondary study objectives
Electrocardiogram
Number of Participants With Adverse Events (AEs)
Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)
+1 more

Side effects data

From 2022 Phase 3 trial • 1831 Patients • NCT04003389
9%
Headache
5%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fezolinetant 45 mg
Placebo
Fezolinetant 30 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Fezolinetant: Normal Hepatic FunctionExperimental Treatment1 Intervention
Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1.
Group II: Fezolinetant: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1.
Group III: Fezolinetant: Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fezolinetant
2020
Completed Phase 3
~2880

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
200 Previous Clinical Trials
122,525 Total Patients Enrolled
Executive Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
25 Previous Clinical Trials
8,226 Total Patients Enrolled
~5 spots leftby Nov 2025
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