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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT04482270

Public ClinicalTrials.gov record NCT04482270. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 7, 2026, 10:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1 Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Fezolinetant Compared to Subjects With Normal Hepatic Function

Study identification

NCT ID
NCT04482270
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Enrollment
26 participants

Conditions and interventions

Interventions

  • fezolinetant Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 1, 2020
Primary completion
Mar 21, 2021
Completion
Mar 21, 2021
Last update posted
Oct 16, 2024

2020 – 2021

United States locations

U.S. sites
4
U.S. states
2
U.S. cities
4
Facility City State ZIP Site status
Clinical Research of West Florida, Inc. Clearwater Florida 33765
Clinical Pharmacology of Miami, LLC Miami Florida 33014-361
Orlando Clinical Research Center Orlando Florida 32809
American Research Corporation San Antonio Texas 72815

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04482270, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 16, 2024 · Synced May 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04482270 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →