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Daridorexant 50 mg for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Idorsia Pharmaceuticals Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 72 hours after study treatment administration (total duration: up to 4 days)

Awards & highlights

Study Summary

This trial studied how much of a sleep drug would be found in breastmilk of nursing mothers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 72 hours after study treatment administration (total duration: up to 4 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 72 hours after study treatment administration (total duration: up to 4 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 72 hours after study treatment administration (total duration: up to 4 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Milk pharmacokinetic endpoints: Amount of daridorexant excreted (mg)

Other outcome measures

Milk pharmacokinetic endpoints: Fraction (percentage) of dose excreted in breast milk

Milk pharmacokinetic endpoints: Relative infant daridorexant dose (percentage)

Plasma pharmacokinetic endpoints: AUC0-inf

+4 more

Side effects data

From 2020 Phase 3 trial • 924 Patients • NCT03575104

12%

Nasopharyngitis

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Daridorexant 10 mg

Daridorexant 25 mg

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: Daridorexant 50 mgExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daridorexant

2020

Completed Phase 3

~1090

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor

118 Previous Clinical Trials

32,447 Total Patients Enrolled

Clinical TrialsStudy DirectorIdosia Pharmaceuticals Ltd

2,199 Previous Clinical Trials

888,492 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies on this trial for volunteers?

"Clinicialtrials.gov indicates that this study is not currently recruiting individuals, as the trial was first posted on November 30th 2022 and last edited a few weeks ago. However, there are 840 other trials actively seeking participants at present time."

Answered by AI

Does Daridorexant 50mg pose any significant risks to users?

"The safety of Daridorexant 50 mg has been assigned a score of 1, as this is an early phase trial with little evidence backing its efficacy or safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05632393.