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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Lemborexant oral tablets.
PPD Phase 1 Clinic
Las Vegas, Nevada, United States
Ae: Cumulative Total (Unchanged) Amount of Lemborexant Excreted in Breast Milk Over the Entire Collection
Time frame: 0-240 hours post-dose
Fraction (Percentage) of Dose Excreted in Breast Milk
Fraction of dose excreted will be calculated as: Ae/Administered dose.
Time frame: 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.
Time frame: 0-240 hours post-dose
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Time frame: 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).
Time frame: Up to 215 days
Number of Participants Reporting one or More TEAEs Based on Dose-relationship of Adverse Events (AEs)
Time frame: Up to 215 days
Number of Participants With Clinically Significant Change in 12-lead Electrocardiogram (ECG) Findings
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 215 days
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Time frame: Baseline up to 215 days
Number of Participants With Markedly Abnormal Change From Baseline in Laboratory Parameters
Time frame: Baseline up to 215 days