Clinical trial NCT01311882: A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1)
Official title: A Multiple Dose Study to Evaluate Next Day Effects of MK-4305 on Driving Performance in Healthy Non-Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insomnia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-03-10
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate next-day residual effects of MK-4305 on highway driving performance in healthy, non-elderly participants.


Eligibility criteria: 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

Primary outcomes:
measure: Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
timeFrame: Day 2
Secondary outcomes:
measure: Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo
timeFrame: Day 2
measure: Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
timeFrame: Day 9
measure: Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo
timeFrame: Day 9
measure: Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo)
timeFrame: Day 2 and Day 9
measure: Word learning test (MK-4305 versus placebo)
timeFrame: Day 2 and Day 9
measure: Body sway area: Area of the 95% confidence ellipse enclosing the center of pressure (A95) (MK-4305 versus placebo)
timeFrame: Day 2 and Day 9
measure: Number of participants with adverse events
timeFrame: Up to 14 days after last dose
measure: Number of participants discontinued from study due to adverse events
timeFrame: Up to 14 days after last dose
Other outcomes:
Locations:
city: Haarlem
country: Netherlands
facility: Merck Sharp & Dohme B.V.
Study officials:
References:
citation: Vermeeren A, Sun H, Vuurman EF, Jongen S, Van Leeuwen CJ, Van Oers AC, Palcza J, Li X, Laethem T, Heirman I, Bautmans A, Troyer MD, Wrishko R, McCrea J. On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg: A Study in Non-Elderly Healthy Volunteers. Sleep. 2015 Nov 1;38(11):1803-13. doi: 10.5665/sleep.5168.