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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT04476849

Public ClinicalTrials.gov record NCT04476849. 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 14, 2026, 7:19 PM 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 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

Study identification

NCT ID
NCT04476849
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Astellas Pharma Global Development, Inc.
Industry
Enrollment
27 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
Aug 9, 2020
Primary completion
Mar 5, 2022
Completion
Mar 10, 2022
Last update posted
Oct 16, 2024

2020 – 2022

United States locations

U.S. sites
7
U.S. states
3
U.S. cities
7
Facility City State ZIP Site status
National Institute of Clinical Research Garden Grove California 92844
Inland Empire Clinical Trials, LLC Rialto California 92377
Clinical Research of West Florida, Inc. Clearwater Florida 33765
Accel Research Sites - DeLand Clinical Research Unit DeLand Florida 32720
Clinical Pharmacology of Miami, LLC Miami Florida 33014-3616
Orlando Clinical Research Center Orlando Florida 32809
Prism research, LLC Saint Paul Minnesota 55114

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 NCT04476849, 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 14, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04476849 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →