A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1)

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

Official Title
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A Multiple Dose Study to Evaluate Next Day Effects of MK-4305 on Driving Performance in Healthy Non-Elderly Subjects

Conditions
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Insomnia

Intervention / Treatment
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* Drug: MK-4305 40 mg
* Drug: MK-4305 20 mg
* Drug: Zopiclone
* Drug: Grossly Matching Placebo for Zopiclone
* Drug: Matching Placebo for MK-4305


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-4305 40 mg<br>Day 1 and Day 8- 4 x 10 mg MK-4305 and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 | Drug: MK-4305 40 mg<br>* 4 x 10 mg MK-4305 tablets<br>Drug: Grossly Matching Placebo for Zopiclone<br>* Grossly Matching Placebo for Zopiclone<br>|
| Experimental: MK-4305 20 mg<br>Day 1 and Day 8- 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo | Drug: MK-4305 20 mg<br>* 2 x 10 mg MK-4305 tablets<br>Drug: Grossly Matching Placebo for Zopiclone<br>* Grossly Matching Placebo for Zopiclone<br>Drug: Matching Placebo for MK-4305<br>* Matching Placebo for MK-4305<br>|
| Active Comparator: Zopiclone 7.5 mg<br>Day 1 and Day 8- 1 x 7.5 mg zopiclone and 4 x 10 mg MK-4305 matching placebo; Days 2-7- 4 x 10 mg MK-4305 matching placebo | Drug: Zopiclone<br>* 1 x 7.5 mg Zopiclone tablet<br>* Other names: Zimovane;Drug: Matching Placebo for MK-4305<br>* Matching Placebo for MK-4305<br>|
| Placebo Comparator: Placebo<br>Day 1 and Day 8- 4 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 matching placebo | Drug: Grossly Matching Placebo for Zopiclone<br>* Grossly Matching Placebo for Zopiclone<br>Drug: Matching Placebo for MK-4305<br>* Matching Placebo for MK-4305<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo |  | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo |  | Day 2 | 
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo |  | Day 9 | 
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone 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 | 
| Body sway area: Area of the 95% confidence ellipse enclosing the center of pressure (A95) (MK-4305 versus placebo) |  | Day 2 and Day 9 | 
| 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 |