Trials / Completed
CompletedNCT04890561
A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
An Open-label, Single Dose Study to Evaluate Lemborexant in Milk of Healthy Lactating Women
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lemborexant | Lemborexant oral tablets. |
Timeline
- Start date
- 2021-05-17
- Primary completion
- 2021-08-12
- Completion
- 2021-08-12
- First posted
- 2021-05-18
- Last updated
- 2021-09-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04890561. Inclusion in this directory is not an endorsement.