- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05702177
A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented
May 11, 2023 updated by: Idorsia Pharmaceuticals Ltd.
Single-center, Randomized, Double-blind, Single-dose, 3-way Crossover Study to Compare the Effects of Daridorexant and Placebo on Postural Stability, the Auditory Awakening Threshold, and Cognitive Function in the Middle-of-the-night Following Evening Administration to Healthy Adult and Elderly Subjects
A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Idorsia Clinical Trials Information
- Phone Number: +1 856 66 13 721
- Email: idorsiaclinicaltrials@idorsia.com
Study Locations
-
-
-
Leiden, Netherlands, 2333CL
- Centre for Human Drug Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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.
- Male and female subjects aged 18 years or older at Screening (18 subjects must be 65 years or older).
- Woman of childbearing potential (WoCBP) who has a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose. She must agree to use consistently and correctly (from Screening, during the entire study, and for at least 5-7 days after last study treatment administration) an acceptable method of contraception with a failure rate of less than 1% per year, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated 1 month before first treatment administration.
- Woman of non-childbearing potential, i.e., postmenopausal (defined as 12 consecutive months with no menses without an alternative medical cause, confirmed by a follicle-stimulating hormone [FSH] test), with previous bilateral salpingectomy, bilateral-oophorectomy or hysterectomy, or with premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, or uterine agenesis.
- Body mass index (BMI) of 18.0 to 35.0 kg/m2 (inclusive) at Screening.
- Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the study requirements.
Exclusion Criteria:
- Known hypersensitivity to daridorexant, or treatments of the same class, or any of its excipients.
Any known factor or disease (e.g., unstable medical condition, significant medical disorder, or acute illness) that might interfere with subject's safety, study conduct, or interpretation of the results, such as
- History of narcolepsy.
- Shift work within 2 weeks prior to Screening, or planned shift work during the study.
- Travel across 3 or more time zones within 1 week prior to Screening, or planned travel across 3 or more time zones during the study.
- Previous (i.e., within 2 weeks prior to first study treatment administration) and ongoing treatment with any prescribed central nervous system (CNS)-active medications, and/or diuretics that would affect nighttime rest, and/or moderate to strong cytochromes P450(CYP)3A4 inhibitors or inducers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Daridorexant 25 mg
Subjects will receive a daridorexant 25 mg tablet for oral administration.
|
A single-dose of daridorexant 25 mg will be administered in the evening 30 minutes prior to bedtime.
Other Names:
|
Experimental: Daridorexant 50 mg
Subjects will receive a daridorexant 50 mg tablet for oral administration.
|
A single-dose of daridorexant 50 mg will be administered in the evening 30 minutes prior to bedtime.
Other Names:
|
Placebo Comparator: Placebo
Subjects will receive a daridorexant-matching placebo tablet for oral administration.
|
A single-dose of placebo matching daridorexant will be administered in the evening 30 minutes prior to bedtime.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment difference in postural stability (daridorexant and placebo)
Time Frame: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
|
Postural stability in the MOTN (at 4 h post-dose) evaluated by body sway.
Body sway will be assessed approximately 5 min after awakening, with the subject standing comfortably, with eyes closed, using a body sway meter (string attached to the waist).
Body movements over 2 min are integrated and expressed as mm sway.
|
Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment difference in auditory awakening threshold (daridorexant and placebo)
Time Frame: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
|
The auditory awakening threshold will be assessed at 4 h post dose by applying a 1000 Hz tone, starting at a noise level of 35 dB, increasing in steps of 5 dB until either the subject is awake, or the maximum noise level (100 dB) is reached.
The tone will be delivered via a calibrated loudspeaker for 3 s with a 15 s interval between the different noise levels.
The subjects must confirm awakening by verbally saying "I'm awake" or similar response, e.g., waving a hand.
If a subject does not respond after receiving the initial 100 dB tone, additional 100 dB stimuli will be applied in 15 s intervals for up to 2 min.
The outcome measure is the noise level (dB) at which subjects indicate that they are awake.
If a subject remains asleep, he/she will be physically awakened by a technician.
If a subject will not awaken to any of the tones presented, the maximum 100 dB tone will be recorded as the auditory awakening threshold.
|
Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
|
Treatment difference in the timed up and go test (daridorexant and placebo)
Time Frame: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
|
Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
|
|
Treatment difference in the visual verbal learning test (daridorexant and placebo)
Time Frame: Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
|
Approximately 4 hours post-dose on Day 2 of the treatment period (daridorexant and placebo). Total duration: 12 hours.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2023
Primary Completion (Actual)
April 25, 2023
Study Completion (Actual)
April 25, 2023
Study Registration Dates
First Submitted
January 5, 2023
First Submitted That Met QC Criteria
January 17, 2023
First Posted (Actual)
January 27, 2023
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-078-118
- 2022-002922-28 (EudraCT Number)
- NL83038.056.22 (Other Identifier: CCMO)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Daridorexant 25 mg
-
Idorsia Pharmaceuticals Ltd.RecruitingInsomniaSpain, United States, Belgium, Germany, Bulgaria
-
Idorsia Pharmaceuticals Ltd.CompletedInsomnia DisorderUnited States, Germany, Canada, Denmark, Poland, Spain, Switzerland, Belgium, Bulgaria, Finland, France, Hungary, Korea, Republic of, Sweden
-
Idorsia Pharmaceuticals Ltd.Completed
-
Idorsia Pharmaceuticals Ltd.CompletedInsomnia DisorderUnited States, Germany, Australia, Canada, Denmark, Italy, Poland, Serbia, Spain, Switzerland
-
Idorsia Pharmaceuticals Ltd.Completed
-
Jiangsu Simcere Pharmaceutical Co., Ltd.Recruiting
-
Zydus Lifesciences LimitedRecruitingAmyotrophic Lateral SclerosisIndia
-
ViiV HealthcareGlaxoSmithKline; Janssen PharmaceuticalsCompletedInfection, Human Immunodeficiency VirusUnited States
-
PeriPharmIdorsia Pharmaceuticals Ltd.Not yet recruiting
-
Jiangsu Simcere Pharmaceutical Co., Ltd.Completed