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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Daridorexant 25 mg; Drug: Daridorexant 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05702177

NL83038.056.22 (Other Identifier)

2022-002922-28 (EudraCT Number)

ID-078-118

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Daridorexant 25 mg

Experimental group

Description:

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

Treatment:

Drug: Daridorexant 25 mg

Daridorexant 50 mg

Experimental group

Description:

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

Treatment:

Drug: Daridorexant 50 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo