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.

Completed

Conditions: Insomnia
sleeplessness
10040991

Registration Number: NL-OMON48154

Lead Sponsor: Idorsia Pharaceuticals Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 56

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Driving performance as measured by the SDLP (difference from placebo, cm) on<br /><br>Day 2 and 5 at 9 h post dose following administration of ACT-541468.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Effects of ACT-541468 on Days 2 and 5 on other driving performance parameters 9<br /><br>h post dose:<br /><br>- Mean lateral position (MLP).<br /><br>- Mean speed (MS).<br /><br>- SD of the mean speed (SDMS).<br /><br>- Number of lapses (lapses are short periods of inattention and reduced<br /><br>alertness which may be a risk factor for car crashes. A lapse is defined as<br /><br>change from the steady lateral position of * 100 cm for * 4 s.)<br /><br>- Drive safety score (DSS), a 24-item composite safety score.<br /><br>- Subjective driving performance and effort scale.<br /><br><br /><br>Safety endpoints:<br /><br>- Treatment-emergent AEs from study treatment administration up to EOT in each<br /><br>treatment period.<br /><br>- Treatment-emergent SAEs from study treatment administration up to EOT in each<br /><br>treatment period.</p><br>