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NCT04476849 · ClinicalTrials.gov registry record · Phase 1
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 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT04476849 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 27 participants.
The verdict
NCT04476849, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study 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.
Interventions
- DRUG fezolinetant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2022-03-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04476849
The ClinicalTrials.gov registry entry for NCT04476849 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which fezolinetant is the first listed.
NCT04476849 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04476849 about?
NCT04476849 is a clinical study titled "A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function". 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. T...
What is the current status of trial NCT04476849?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2020-08-10. Estimated completion is 2022-03-11.
What interventions are being tested in trial NCT04476849?
The interventions under investigation include: fezolinetant (DRUG).
Who is sponsoring clinical trial NCT04476849?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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