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

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT04476849

Astellas Study ID

The unique identification code given by the study sponsor.

2693-CL-0008

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

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Condition

Healthy Volunteer, Kidney Disease

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 Years - 75 Years

Sex

Female

Product

fezolinetant

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Aug 2020 - Mar 2022

Masking

None (Open Label)

Enrollment number

27

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 summary

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Locations

Orlando Clinical Research Center

Orlando, United States, 32809

Clinical Research of West Florida, Inc.

Clearwater, United States, 33765

Clinical Pharmacology of Miami, LLC

Miami, United States, 33014-3616

Prism research, LLC

Saint paul, United States, 55114

National Institute of Clinical Research

Garden Grove, United States, 92844

Accel Research Sites - DeLand Clinical Research Unit

DeLand, United States, 32720

Inland Empire Clinical Trials, LLC

Rialto, United States, 92377

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