A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: ACT-541468
Other: Placebo
Drug: Zopiclone 7.5 mg
Details and patient eligibility
About
A clinical study to assess next-day driving performance following evening administrations of ACT-541468 in middle-aged and elderly subjects
Enrollment
56 patients
Sex
All
Ages
50 to 80 years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
General criteria:
- Signed informed consent prior to any study-mandated procedure.
- Male and female subjects aged between 50 and 80 years (inclusive) at Screening.
- 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 a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.
- Women of non-childbearing potential (i.e., postmenopausal, XY genotype, Turner syndrome, uterine agenesis).
Study-specific criteria
- Subject has a valid driving license for more than 5 years, has driven at least 3000 km/year on average in the past 2 years.
- Normal visual acuity (corrected or uncorrected).
Exclusion Criteria:
General criteria:
- Pregnant or lactating women.
- Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results.
- History or presence of rhythm disorders
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Study-specific criteria:
- Current or previous diagnosis of insomnia-related disorder according to the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria.
- History of alcoholism, drug abuse, or regular use of sedative drugs or hypnotics within 3 years prior to Screening.
- 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 (approx. 250 mL) of beer or 1 measure (25 mL) of spirits or 1 glass (125 mL) of wine.
- Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy.
- Activities that disturb the circadian rhythm (e.g., working night shift, travelling across 3 time zones) within 2 weeks before (each) study treatment.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Quadruple Blind
56 participants in 4 patient groups
Treatment A (50 mg ACT-541468)
Experimental group
Description:
1 tablet of ACT-541468 50 mg + 1 tablet of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period A.
Treatment:
Other: Placebo
Drug: ACT-541468
Treatment B (100 mg ACT-541468)
Experimental group
Description:
2 tablets of ACT-541468 50 mg + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period B.
Treatment:
Other: Placebo
Drug: ACT-541468
Treatment C (7.5 mg zopiclone)
Experimental group
Description:
2 tablets of ACT-541468 matching placebo + 1 capsule of zopiclone 7.5 mg administered in the evening on Days 1 and 4 of Treatment Period C. In the evenings of Days 2 and 3, subjects will receive placebo (i.e., 2 tablets of ACT-541468 matching placebo + zopiclone matching placebo).
Treatment:
Drug: Zopiclone 7.5 mg
Other: Placebo
Treatment D (placebo)
Experimental group
Description:
2 tablets of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period D.
Treatment:
Other: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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