Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-31 @ 2:47 PM
Study NCT ID:
NCT04890561
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2021-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
Sponsor:
Eisai Inc.
Organization:
Study Overview
Official Title:
An Open-label, Single Dose Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: