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NCT04890561 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
A Phase 1 study of Healthy Volunteers, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04890561: Completed Phase 1 study of Healthy Volunteers, sponsored by Eisai.
NCT04890561 is a Phase 1 study of Healthy Volunteers that has completed, run by Eisai. The registered enrollment target is 8 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04890561, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of the study is to estimate the cumulative amount of lemborexant excreted in breast milk following a single dose administration of lemborexant 10 milligram (mg) to healthy lactating women and to estimate the relative infant dose (RID) expressed as a percent of the daily maternal dose.
Conditions Studied
Interventions
- DRUG Lemborexant
Study Locations (1)
Nevada
- PPD Phase 1 Clinic - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-05-17 |
| Est. Completion | 2021-08-12 |
| Phase | Phase 1 |
What the finished NCT04890561 record still lists
NCT04890561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Lemborexant is the first listed.
NCT04890561 reports a single indexed study location in Nevada.
Frequently Asked Questions
What is clinical trial NCT04890561 about?
NCT04890561 is a clinical study titled "A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women". The primary purpose of the study is to estimate the cumulative amount of lemborexant excreted in breast milk following a single dose administration of lemborexant 10 milligram (mg) to healthy lactating women and to estimate the relative infant dose (RID) expressed as a percent of the daily maternal ...
What is the current status of trial NCT04890561?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-05-17. Estimated completion is 2021-08-12.
What conditions does trial NCT04890561 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04890561?
The interventions under investigation include: Lemborexant (DRUG).
Who is sponsoring clinical trial NCT04890561?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04890561 being conducted?
This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04890561's enrollment target sits among peer trials
8 269th of 283 higher than 7 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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