HealthyPhase 1NCT05632393
A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women
A Phase 1 study testing Daridorexant in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in United States.
Trial summary
A study to measure daridorexant in breast milk of healthy lactating women Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Daridorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2023to 30 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: 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
- Conditions
- Healthy
- Being tested
- Daridorexant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaridorexantDrug
Daridorexant will be available as film-coated tablets for oral administration formulated at a strength of 50 mg.
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant 50 mg | Experimental | Daridorexant 50 mg will be administered once in the morning of Day 1. Receives: Drug: Daridorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Milk pharmacokinetic endpoints: Amount of daridorexant excreted (mg)
Cumulative amount excreted in breast milk over the collection time
Measured: 0 to 72 hours after study treatment administration (Total duration: up to 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start16 Jan 2023
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idosia Pharmaceuticals Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632393
- Sponsor's protocol ID
- ID-078-122
- Status last verified
- May 2023
- First submitted
- 8 Nov 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-dose Phase 1 Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women
- ClinicalTrials.gov ID
- NCT05632393
- Acronym / sponsor ID
- ID-078-122
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to measure daridorexant in breast milk of healthy lactating women
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daridorexant 50 mg | Experimental | Drug: DaridorexantDaridorexant 50 mg will be administered once in the morning of Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaridorexantDaridorexant will be available as film-coated tablets for oral administration formulated at a strength of 50 mg. | Drug | Daridorexant 50 mg |
Primary outcome
Milk pharmacokinetic endpoints: Amount of daridorexant excreted (mg)
Time frame: 0 to 72 hours after study treatment administration (Total duration: up to 4 days)
Cumulative amount excreted in breast milk over the collection time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Idosia Pharmaceuticals Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Daridorexant in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.