A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women

Phase 1 Completed 8 enrolled Eisai Inc.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2021-05-17
Primary completion: 2021-08-12
Completion: 2021-08-12

Publications

Rawal S, Brimhall D, Aluri J, Cheng JY, Hall N, Moline M. Lemborexant levels in breast milk after single doses in healthy, lactating women. Br J Clin Pharmacol. 2024 Jan;90(1):158-163. doi: 10.1111/bcp.15880. Epub 2023 Aug 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lemborexant	Small molecule	10 mg	Oral

Indications

No indication recorded.