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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lemborexant 10 mg | Experimental | Participants will receive a single dose of lemborexant 10 mg tablet, orally on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lemborexant | Drug | Lemborexant oral tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ae: Cumulative Total (Unchanged) Amount of Lemborexant Excreted in Breast Milk Over the Entire Collection | 0-240 hours post-dose | |
| Fraction (Percentage) of Dose Excreted in Breast Milk | Fraction of dose excreted will be calculated as: Ae/Administered dose. | 0-240 hours post-dose |
| RID: Relative Infant Dose | Relative infant dose is defined as the infant drug exposure via breast milk which is the body weight-adjusted percentage of maternal dose. Relative infant dose will be calculated by the formula: Daily infant dose milligram per kilogram (mg/kg)/maternal dose (mg/kg)*100, where estimated daily infant dose is as per the Food and Drug Administration (FDA) guidance (2019). Daily infant dose (mg/kg) = Ae/weight of infant. | 0-240 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) | Up to 215 days | |
| Number of Participants Reporting one or More TEAEs Based on Severity | All TEAEs will be graded on a 3-point scale (mild, moderate, and severe). The definitions are as follows: Mild (Discomfort noticed, but no disruption of normal daily activity); Moderate (Discomfort sufficient to reduce or affect normal daily activity); Severe (Incapacitating, with inability to work or to perform normal daily activity). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase 1 Clinic | Las Vegas | Nevada | 89113 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37565541 | Derived | 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. |
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Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| ID | Term |
|---|---|
| C000634104 | lemborexant |
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| Up to 215 days |
| Number of Participants Reporting one or More TEAEs Based on Dose-relationship of Adverse Events (AEs) | Up to 215 days |
| Number of Participants With Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings | Up to 215 days |
| Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values | Baseline up to 215 days |
| Number of Participants With Markedly Abnormal Change From Baseline in Laboratory Parameters | Baseline up to 215 days |