Insomnia Sleeping disorders
Conditions
Interventions
There will be 4 study treatments (A, B, C, and D) and each subject will receive
all 4 treatments in a blinded crossover fashion. Each subject will be
randomized to one of the sequences defined using
Sponsors
Idorsia Pharmaceuticals LTD
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent in a language understandable to the subject prior to any study-mandated procedure. 2. Healthy male and female subjects aged between 18 and 45 years (inclusive) at screening. 3. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use (from screening, during the entire study, and for at least 90 days after last study treatment intake) a reliable method of contraception with a failure rate of
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Known hypersensitivity to ACT-541468 or treatments of the same class, or any of its excipients. 3. History of major medical or surgical disorders, which in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed). 4. Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study. 5. Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions. 6. Veins unsuitable for intravenous (i.v.) puncture on either arm (e.g., veins that are difficult to locate, access, or puncture, veins with a tendency to rupture during or after puncture). 7. Participation in a clinical study involving study treatment administration within 3 months prior to screening or in more than 4 clinical studies within 1 year prior to screening. 8. Excessive caffeine consumption, defined as 800 mg per day at screening 9. Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) within 3 months prior to screening and inability to refrain from nicotine intake from screening until End-of-Study (EOS). 10. Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John*s Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first study treatment administration. 11. Loss of 250 mL or more of blood within 3 months prior to screening. 12. Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening. 13. Positive results from the HIV serology at screening. 14. Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. 15. Legal incapacity or limited legal capacity at screening. 16. History or clinical evidence of alcoholism or drug abuse. 17. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females). One unit is equivalent to a half-pint (220 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine. 18. Individuals of Asian descent or other individuals reporting ethanol intolerance (Asian descent defined as 1 or more parents or grandparents of Asian origin). 19. Modified Swiss Narcolepsy Scale total score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline for: * Saccadic peak velocity (degrees/sec) to assess sedation. * Smooth pursuit (%) to assess eye movement coordination and attention. * Adaptive tracking (%) to assess visuo-motor control and vigilance. * Body sway (antero-posterior in mm / 2 min) to assess postural stability. * Visual analog scales (VAS) Bond & Lader to assess subjective alertness, mood, and calmness. * VAS for alcohol intoxication to assess subjective effects of ethanol. | — |
Secondary
| Measure | Time frame |
|---|---|
| ACT-541468 PK endpoints for treatments A and B: * The area under the plasma concentration-time curve (AUC) from time zero to 24 h (AUC0*24). * The AUC from zero to infinity (AUC0**). * The maximum plasma concentration (Cmax). * The time to reach Cmax (tmax). * The terminal elimination half-life (t*). Ethanol PK endpoints for treatments A and C: * Breath ethanol concentrations (BrEC). * Total ethanol dose (in grams) required to maintain the 0.6 g/L ethanol clamp. Safety endpoints: * Treatment-emergent AEs from study treatment administration up to EOT in each treatment period. * Treatment-emergent SAEs from study treatment administration up to EOT in each treatment period. | — |
Countries
Netherlands
Outcome results
None listed