A single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 4-way cross-over study to assess next-day driving performance following single and multiple evening administrations of ACT-541468 in middle-aged and elderly subjects. - Driving performance of ACT-541468

Idorsia Pharaceuticals Ltd.0 个研究点目标入组 56 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•1. Be male or female (of nonchildbearing potential) aged 50 to 80 years, inclusive, at the Screening Visit.
•2. Have a body mass index *18.5 and *30.0 kg/m2 at the Screening Visit.
•3. Be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety
•tests, medical history, physical examination and vital sign measurements performed at the
•screening visit and before the first dose of study drug.

•1. Pregnant or lactating women.
•2. Known hypersensitivity to ACT-541468, zopiclone, or treatments of the same class, or any of their excipients.
•3. Unstable medical condition, significant medical disorder, or acute illness within 2 months prior to Screening.
•4. Current heavy tobacco user (* 15 cigarettes per day) or smoker with an urge to wake up during the night to smoke.
•5. No history of narcolepsy, cataplexy or fainting.
•6. Mini Mental State Examination (MMSE) score < 25 at Screening.
•7. Current or previous diagnosis of insomnia-related disorder according to the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria.
•8. Modified Swiss Narcolepsy Scale total score < 0 at Screening.
•9. Activities that disturb the circadian rhythm (e.g., working night shift, travelling across 3 time zones) within 2 weeks before (each) study treatment.

发起方

Idorsia Pharaceuticals Ltd.