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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04890561
The ClinicalTrials.gov registry entry for NCT04890561 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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