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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: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT04476849 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AUCinf will be recorded from the PK plasma samples collected.
Interventions
- DRUG fezolinetant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2022-03-11 |
| Phase | Phase 1 |
What the finished NCT04476849 record still lists
NCT04476849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which fezolinetant is the first listed.
NCT04476849 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04476849's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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