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NCT04482270 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT04482270: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT04482270 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04482270, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 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 mild and moderate hepatic impairment compared to healthy female participants with normal hepatic function. This study will also evaluate the safety and tolerability of a single oral dose of fezolinetant in female participants with mild and moderate hepatic impairment and healthy female participants with normal hepatic function.
Primary Outcome
AUCinf will be recorded from the PK plasma samples collected.
Interventions
- DRUG fezolinetant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-09-02 |
| Est. Completion | 2021-03-22 |
| Phase | Phase 1 |
What the finished NCT04482270 record still lists
NCT04482270 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which fezolinetant is the first listed.
NCT04482270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04482270 about?
NCT04482270 is a clinical study titled "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". 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 mild and moderate hepatic impairment compared to healthy female participants with normal hepatic function. This study will also eval...
What is the current status of trial NCT04482270?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-09-02. Estimated completion is 2021-03-22.
What interventions are being tested in trial NCT04482270?
The interventions under investigation include: fezolinetant (DRUG).
Who is sponsoring clinical trial NCT04482270?
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 NCT04482270's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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