A Study to Evaluate Lemborexant in Milk of Healthy Lactating Women

NCT04890561 | Completed Phase 1 FDA Drug

• 1 other identifier: E2006-A001-010
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• 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

  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

Study Arms (1)

Lemborexant 10 mg

EXPERIMENTAL

Participants will receive a single dose of lemborexant 10 mg tablet, orally on Day 1.

Drug: Lemborexant

Interventions

Lemborexant DRUG

Lemborexant oral tablets.

Also known as: E2006, Dayvigo

Lemborexant 10 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a healthy lactating female at least 18 years of age and willing to sign an informed consent prior to any study-related activities.
• The participant must have had a normal term pregnancy and has been actively breastfeeding or pumping for at least 5 weeks postpartum; lactation must be well-established and the mother not experiencing problems with feeding her infant breast milk. Participants planning on weaning their infants independent of study participation, who meet aforementioned requirements, will be considered for enrolment in the study.
• Is willing not to breastfeed for 11 days after the study drug administration.
• Breastfeeds an infant who is already able to feed from a bottle.
• Agrees to collect all breast milk from predose to end of the study using an electric pump provided by the sponsor.
• Is considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the investigator.

You may not qualify if:

• Has a positive pregnancy test at Screening or Baseline.
• Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism.
• Any history of gastrointestinal surgery that may affect pharmacokinetic (PK) profiles, example, hepatectomy, nephrectomy, digestive organ resection (but not cholecystectomy) at Screening or Baseline.
• Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline.
• A prolonged QT interval by Fridericia (QTcF) (QTcF greater than \[\>\] 450 milliseconds \[ms\]) as demonstrated by a repeated ECG at Screening.
• Any suicidal behavior (per the Suicidal Behavior section of the Columbia-Suicide Severity Rating Scale) within 10 years of Screening.
• Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.
• Exposure within the last 14 days to an individual with confirmed or probable coronavirus disease (COVID-19) or symptoms within the last 14 days that are on the most recent centers for disease control and prevention (CDC) list of COVID symptoms or any other reason to consider the participant at potential risk for an acute COVID-19 infection.
• Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
• Is a smoker (\>5 cigarettes, or nicotine equivalent, per day).
• Has a positive result for urine drug screening.
• Has undergone surgery (other than caesarean section) or donated blood within 8 weeks prior to the start of the study.
• Used any prescription or over-the-counter medications, which may impact plasma concentration of lemborexant, within 1 week or 5 half-lives, whichever is longer, before Screening.
• Hypersensitivity to the study drug or any of the excipients.
• History of or has concomitant medical condition(s) that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

PPD Phase 1 Clinic

Las Vegas, Nevada, 89113, United States

Location

Related Publications (1)

• 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.

  PMID: 37565541 DERIVED

MeSH Terms

Interventions

lemborexant

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 18, 2021
• Study Start: May 17, 2021
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)