A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women

NCT05632393 | Completed Phase 1 FDA Drug

• 1 other identifier: ID-078-122
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A study to measure daridorexant in breast milk of healthy lactating women

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Milk pharmacokinetic endpoints: Amount of daridorexant excreted (mg)

  Cumulative amount excreted in breast milk over the collection time

  0 to 72 hours after study treatment administration (Total duration: up to 4 days)

Other Outcomes (7)

• 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)

• Plasma pharmacokinetic endpoints: Cmax

  0 to 72 hours after study treatment administration (Total duration: up to 4 days)

Study Arms (1)

Daridorexant 50 mg

EXPERIMENTAL

Daridorexant 50 mg will be administered once in the morning of Day 1.

Drug: Daridorexant

Interventions

Daridorexant DRUG

Daridorexant will be available as film-coated tablets for oral administration formulated at a strength of 50 mg.

Daridorexant 50 mg

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Labcorp Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

daridorexant

Study Officials

• Clinical Trials

  Idosia Pharmaceuticals Ltd

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 30, 2022
• Study Start: January 16, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)