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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2023-04-25

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Daridorexant 25 mg

Subjects will receive a daridorexant 25 mg tablet for oral administration.

Group Type EXPERIMENTAL

Daridorexant 25 mg

Intervention Type DRUG

A single-dose of daridorexant 25 mg will be administered in the evening 30 minutes prior to bedtime.

Daridorexant 50 mg

Subjects will receive a daridorexant 50 mg tablet for oral administration.

Group Type EXPERIMENTAL

Daridorexant 50 mg

Intervention Type DRUG

A single-dose of daridorexant 50 mg will be administered in the evening 30 minutes prior to bedtime.

Placebo

Subjects will receive a daridorexant-matching placebo tablet for oral administration.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

A single-dose of placebo matching daridorexant will be administered in the evening 30 minutes prior to bedtime.

Interventions

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Daridorexant 25 mg

A single-dose of daridorexant 25 mg will be administered in the evening 30 minutes prior to bedtime.

Intervention Type DRUG

Daridorexant 50 mg

A single-dose of daridorexant 50 mg will be administered in the evening 30 minutes prior to bedtime.

Intervention Type DRUG

Placebo

A single-dose of placebo matching daridorexant will be administered in the evening 30 minutes prior to bedtime.

Intervention Type DRUG

Other Intervention Names

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Quviviq Quviviq

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes