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NCT04641260 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04641260: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT04641260 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04641260, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of fezolinetant under fasted and fed conditions in healthy female participants. The study will also evaluate the safety and tolerability of a single oral dose of fezolinetant under fasted and fed conditions in healthy female participants.
Primary Outcome
AUCinf will be recorded from the PK plasma samples collected.
Interventions
- DRUG Fezolinetant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2021-02-21 |
| Phase | Phase 1 |
What the finished NCT04641260 record still lists
NCT04641260 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Fezolinetant is the first listed.
NCT04641260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04641260 about?
NCT04641260 is a clinical study titled "A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants". The purpose of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of fezolinetant under fasted and fed conditions in healthy female participants. The study will also evaluate the safety and tolerability of a single oral dose of fezolinetant under fasted and fe...
What is the current status of trial NCT04641260?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2020-11-20. Estimated completion is 2021-02-21.
What interventions are being tested in trial NCT04641260?
The interventions under investigation include: Fezolinetant (DRUG).
Who is sponsoring clinical trial NCT04641260?
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 NCT04641260's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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