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

A Prospective, Open-label, Single-dose Phase 1 Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Daridorexant

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Labcorp Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daridorexant 50 mg; Daridorexant 50 mg will be administered once in the morning of Day 1.	Drug: Daridorexant; Daridorexant will be available as film-coated tablets for oral administration formulated at a strength of 50 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Percentage of dose that would be consumed by the infant, adjusted to maternal weight and infant weight on Day -1	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)
Plasma pharmacokinetic endpoints: Tmax		0 to 72 hours after study treatment administration (Total duration: up to 4 days)
Plasma pharmacokinetic endpoints: AUC0-inf		0 to 72 hours after study treatment administration (Total duration: up to 4 days)
Plasma pharmacokinetic endpoints: T1/2		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)

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Investigators: Study Director: Clinical Trials, Idosia Pharmaceuticals Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ID-078-122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No