To evaluate the pharmacodynamic (PD) effects of daridorexant 25mg, 50mg, and placebo in the middle-of-the-night.
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacodynamic endpoints
Secondary outcome
Safety and tolerability endpoints
Background summary
Sleep-promoting drugs should ideally induce sleep while having no considerable
effects on postural stability when getting out of bed during the night, or when
waking up in the morning. In addition, it is a common safety concern with
CNS-depressant drugs that they may decrease the ability of subjects to be
awakened by external stimuli such as a fire alarm. Daridorexant has been
approved for medical use in the United States and Europe and is sold under the
brand name registered QUVIVIQ to treat insomnia. This study will investigate
the side effects of Daridorexant when subjects are abruptly woken in the middle
of the night.
Study objective
To evaluate the pharmacodynamic (PD) effects of daridorexant 25mg, 50mg, and
placebo in the middle-of-the-night.
Study design
Single-center, double-blind, randomized, placebo-controlled, single-dose, 3-way
crossover Phase 1 study.
Intervention
Daridorexant (25mg and 50 mg) and placebo
Study burden and risks
As this study is not conducted in the target population for daridorexant, there
are no anticipated clinical benefits for participants beyond the thorough
medical check-up that each subject will undergo prior to receiving treatments
and at the end of the study. The selection of healthy subjects is justified on
the basis that the nighttime PD variables can be investigated accurately in
this population, without interferences from concomitant diseases or medication.
In addition, results can be compared to previous findings obtained in healthy
subjects when the PD of daridorexant were evaluated at different doses
following daytime administration. However, effects on nighttime PD of patients
with insomnia cannot be derived from this study. Provided the protocol is
adhered to, the exclusion criteria, careful observation, and medical management
will minimize any associated risk in this study.
Hegenheimermattweg 91
CH-4123 Allschwil
CH
Hegenheimermattweg 91
CH-4123 Allschwil
CH
Listed location countries
Age
Inclusion criteria
1. Signed informed consent in a language understandable to the subject prior to
any study-mandated procedure.
2. Male and female subjects aged >= 18 years at Screening (18 subjects must be >=
65 years).
3. 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 < 1% per year, be
sexually inactive, or have a vasectomized partner. If a hormonal contraceptive
is used, it must be initiated at least 1 month before first treatment
administration.
4. 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 salpingo-oophorectomy or hysterectomy, or
with premature ovarian failure (confirmed by a specialist), XY genotype, Turner
syndrome, or uterine agenesis.
5. Body mass index (BMI) of 18.0 to 35.0 kg/m2 (inclusive) at Screening.
6. Ability to communicate well with the investigator, in a language
understandable to the subject, and to understand and comply with the study
requirements.
7. Usual bedtime between 21:30 and 00:30 and usual sleep duration of at least 6
h.
Exclusion criteria
1. Known hypersensitivity to daridorexant, or treatments of the same class, or
any of its excipients.
2. History of narcolepsy.
6. 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
non-compliance with medical regimen; history of hearing impairment, psychiatric
disease; or neurological disorder that may impact sleep, motor performance, or
cognition, including Parkinson disease, predementia, dementia, other
neurodegenerative disorder, and stroke.
16. Shift work within 2 weeks prior to Screening, or planned shift work during
the study.
17. Travel across >= 3 time zones within 1 week prior to Screening, or planned
travel across >= 3 time zones during the study.
18. 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 cytochrome P450 (CYP)3A4 inhibitors or inducers.
19. Mini Mental State Examination (MMSE) score < 25 in subjects >= 65 years at
Screening.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-002922-28-NL |
| CCMO | NL83038.056.22 |