Insomnia
Conditions
Brief summary
This is a study to evaluate next-day residual effects of MK-4305 on highway driving performance in healthy, non-elderly participants.
Interventions
DRUGMK-4305 40 mg
4 x 10 mg MK-4305 tablets
DRUGMK-4305 20 mg
2 x 10 mg MK-4305 tablets
DRUGZopiclone
1 x 7.5 mg Zopiclone tablet
DRUGGrossly Matching Placebo for Zopiclone
Grossly Matching Placebo for Zopiclone
DRUGMatching Placebo for MK-4305
Matching Placebo for MK-4305
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Female participants of reproductive potential must agree to use (and/or have their partner use) acceptable methods of birth control beginning at least 2 weeks prior to the administration of the first dose of study drug throughout the study * Has a body mass index (BMI) within the range of 18 to 30 kg/m\^2 * Possesses a valid driver's license for 3 years or more with at least 5000 km/year on average within the last 3 years * Is capable of driving a manual transmission vehicle and is willing to drive on a highway * Is judged to be in good health * Has a regular sleep pattern * Is not visually impaired
Exclusion criteria
* Has a history of a persistent sleep abnormality * Has neurological disease/cognitive impairment * Has a history of cataplexy * Is a regular user of sedative-hypnotic agents * Is allergic to zopiclone * Has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study start and will travel across 3 or more time zones throughout study duration * Works a night shift and is not able to avoid night shift work within 1 week before each treatment visit * Is pregnant or nursing * Does not qualify as a proficient driver according to the driving instructors evaluation of subject's driving on the driving test practice session
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo | Day 2 |
Secondary
| Measure | Time frame |
|---|---|
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo | Day 9 |
| Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo) | Day 2 and Day 9 |
| Word learning test (MK-4305 versus placebo) | Day 2 and Day 9 |
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo | Day 2 |
| Number of participants with adverse events | Up to 14 days after last dose |
| Number of participants discontinued from study due to adverse events | Up to 14 days after last dose |
| Body sway area: Area of the 95% confidence ellipse enclosing the center of pressure (A95) (MK-4305 versus placebo) | Day 2 and Day 9 |
Countries
Netherlands
Outcome results
None listed