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NCT04277624 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants
A Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT04277624: Completed Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.
NCT04277624 is a Phase 1 study of Healthy Volunteers that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 22 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04277624, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the bioequivalence of a single dose of fezolinetant test formulation compared to a single dose of fezolinetant reference formulation under fasting conditions. This study will also evaluate the safety and tolerability of a single dose of fezolinetant test formulation and a single dose of fezolinetant reference formulation.
Primary Outcome
AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected
Conditions Studied
Interventions
- DRUG fezolinetant - reference formulation
- DRUG fezolinetant - test formulation
Study Locations (1)
Maryland
- PAREXEL Early Phase Clinical Unit - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-02-20 |
| Est. Completion | 2021-02-26 |
| Phase | Phase 1 |
What the finished NCT04277624 record still lists
NCT04277624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which fezolinetant - reference formulation is the first listed.
NCT04277624 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04277624 about?
NCT04277624 is a clinical study titled "A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants". The purpose of this study is to assess the bioequivalence of a single dose of fezolinetant test formulation compared to a single dose of fezolinetant reference formulation under fasting conditions. This study will also evaluate the safety and tolerability of a single dose of fezolinetant test formul...
What is the current status of trial NCT04277624?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2020-02-20. Estimated completion is 2021-02-26.
What conditions does trial NCT04277624 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04277624?
The interventions under investigation include: fezolinetant - reference formulation (DRUG), fezolinetant - test formulation (DRUG).
Who is sponsoring clinical trial NCT04277624?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04277624 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04277624's enrollment target sits among peer trials
22 219th of 283 higher than 64 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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