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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT05632393
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jan 16, 2023
Status verified
May 2023
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

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

Primary Outcome Measure

Milk pharmacokinetic endpoints: Amount of daridorexant excreted (mg) [ Time Frame: 0 to 72 hours after study treatment administration (Total duration: up to 4 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Labcorp Clinical Research Unit Inc.MadisonWisconsin53704-

Find similar trials in Madison, WI

By research site
Labcorp Clinical Research Unit Inc.· Madison, WI

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