This is a study to evaluate next-day residual effects of MK-4305 on highway driving performance in healthy, non-elderly participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
4 x 10 mg MK-4305 tablets
2 x 10 mg MK-4305 tablets
1 x 7.5 mg Zopiclone tablet
Merck Sharp & Dohme B.V.
Haarlem, Netherlands
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
Time frame: Day 2
Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo
Time frame: Day 2
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
Time frame: Day 9
Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo
Time frame: Day 9
Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo)
Time frame: Day 2 and Day 9
Word learning test (MK-4305 versus placebo)
Time frame: Day 2 and Day 9
Body sway area: Area of the 95% confidence ellipse enclosing the center of pressure (A95) (MK-4305 versus placebo)
Time frame: Day 2 and Day 9
Number of participants with adverse events
Time frame: Up to 14 days after last dose
Number of participants discontinued from study due to adverse events
Time frame: Up to 14 days after last dose
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Grossly Matching Placebo for Zopiclone
Matching Placebo for MK-4305