A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects
NCT ID: NCT03892902
Last Updated: 2019-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2019-03-25
2019-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Treatment A (50 mg ACT-541468)
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.
ACT-541468
Film-coated tablet for oral use at a dose strength of 50 mg.
Placebo
Matching to maintain blinding.
Treatment B (100 mg ACT-541468)
2 tablets of ACT-541468 50 mg + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period B.
ACT-541468
Film-coated tablet for oral use at a dose strength of 50 mg.
Placebo
Matching to maintain blinding.
Treatment C (7.5 mg zopiclone)
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).
Zopiclone 7.5 mg
Over-encapsulated to maintain blinding.
Placebo
Matching to maintain blinding.
Treatment D (placebo)
2 tablets of ACT-541468 matching placebo + zopiclone matching placebo administered in the evening on Days 1-4 of Treatment Period D.
Placebo
Matching to maintain blinding.
Interventions
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ACT-541468
Film-coated tablet for oral use at a dose strength of 50 mg.
Zopiclone 7.5 mg
Over-encapsulated to maintain blinding.
Placebo
Matching to maintain blinding.
Eligibility Criteria
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Inclusion 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
* 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.
50 Years
80 Years
ALL
Yes
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Pharmacologist
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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Centre for Human Drug Research
Leiden, , Netherlands
Countries
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Other Identifiers
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ID-078-108
Identifier Type: -
Identifier Source: org_study_id