A clinical study to assess next-day driving performance following evening administrations of ACT-541468 in middle-aged and elderly subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
56
Film-coated tablet for oral use at a dose strength of 50 mg.
Over-encapsulated to maintain blinding.
Matching to maintain blinding.
Centre for Human Drug Research
Leiden, Netherlands
Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 2
SDLP = standard deviation of the lateral position
Time frame: On Day 2 at 9 hours post dose. Duration of the test: 1 hour
Pharmacodynamic endpoint: Driving performance as measured by the SDLB (difference from placebo, cm) using the Green Dino driving simulator - Day 5
SDLP = standard deviation of the lateral position
Time frame: On Day 5 at 9 hours post dose. Duration of the test: 1 hour
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