Healthy
Conditions
Brief summary
A study to measure daridorexant in breast milk of healthy lactating women
Interventions
DRUGDaridorexant
Daridorexant will be available as film-coated tablets for oral administration formulated at a strength of 50 mg.
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure. * Healthy lactating female subject aged at least 18 years at Screening. * Female subject who has delivered a term infant (≥ 37 weeks' gestation) and who is breastfeeding her infant (and/or pumping) for at least 2 weeks postpartum at Screening; lactation must be well-established to maintain an adequate milk supply with regular breastfeeding (and/or pumping, e.g., 3 to 4 times per day and not providing more than 1 supplemental bottle of formula per day and the infant has not started eating solids). Subjects planning on weaning their infants after enrollment who meet the afore mentioned requirements will be considered for enrollment in the study. * Agreement to refrain from breastfeeding any infant with her own milk from Day -1 up to 72 h after study treatment administration. * Ability of subject's infant to feed from a bottle or no anticipated compromise of subject's infant's nutrition with time period of refraining from breastfeeding planned during the study. * Agreement to collect breast milk from pre-dose (directly prior to study treatment administration) to Day 4 (72 h after study treatment administration) using an electric pump provided by the study site. * Must agree to use an acceptable effective method of contraception consistently and correctly (e.g., oral progestin-only contraceptive; implants; intra uterine devices; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide) from Screening up to at least 72 h after study treatment administration, be sexually inactive, or be in same-sex relationship.
Exclusion criteria
* Known hypersensitivity to daridorexant or treatments of the same class, or any of its excipients. * History of narcolepsy. * Mastitis or other condition that prevents the collection of breast milk from one or both breasts at Screening or on Day -1. * History of breast implants, breast augmentation, or breast reduction surgery which prevents the collection of breast milk. * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Milk pharmacokinetic endpoints: Amount of daridorexant excreted (mg) | 0 to 72 hours after study treatment administration (Total duration: up to 4 days) | Cumulative amount excreted in breast milk over the collection time |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma pharmacokinetic endpoints: T1/2 | 0 to 72 hours after study treatment administration (Total duration: up to 4 days) | — |
| Milk pharmacokinetic endpoints: Fraction (percentage) of dose excreted in breast milk | 0 to 72 hours after study treatment administration (Total duration: up to 4 days) | — |
| Milk pharmacokinetic endpoints: Relative infant daridorexant dose (percentage) | 0 to 72 hours after study treatment administration (Total duration: up to 4 days) | Percentage of dose that would be consumed by the infant, adjusted to maternal weight and infant weight on Day -1 |
| Plasma pharmacokinetic endpoints: AUC0-inf | 0 to 72 hours after study treatment administration (Total duration: up to 4 days) | — |
| Plasma pharmacokinetic endpoints: Tmax | 0 to 72 hours after study treatment administration (Total duration: up to 4 days) | — |
| Treatment-emergent (S)AEs | Up to end of study (EOS; total duration: up to 46 days) | — |
| Plasma pharmacokinetic endpoints: Cmax | 0 to 72 hours after study treatment administration (Total duration: up to 4 days) | — |
Countries
United States
Outcome results
None listed