A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1)
NCT ID: NCT01311882
Last Updated: 2016-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2011-04-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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MK-4305 40 mg
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
MK-4305 40 mg
4 x 10 mg MK-4305 tablets
Grossly Matching Placebo for Zopiclone
Grossly Matching Placebo for Zopiclone
MK-4305 20 mg
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
MK-4305 20 mg
2 x 10 mg MK-4305 tablets
Grossly Matching Placebo for Zopiclone
Grossly Matching Placebo for Zopiclone
Matching Placebo for MK-4305
Matching Placebo for MK-4305
Zopiclone 7.5 mg
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
Zopiclone
1 x 7.5 mg Zopiclone tablet
Matching Placebo for MK-4305
Matching Placebo for MK-4305
Placebo
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
Grossly Matching Placebo for Zopiclone
Grossly Matching Placebo for Zopiclone
Matching Placebo for MK-4305
Matching Placebo for MK-4305
Interventions
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MK-4305 40 mg
4 x 10 mg MK-4305 tablets
MK-4305 20 mg
2 x 10 mg MK-4305 tablets
Zopiclone
1 x 7.5 mg Zopiclone tablet
Grossly Matching Placebo for Zopiclone
Grossly Matching Placebo for Zopiclone
Matching Placebo for MK-4305
Matching Placebo for MK-4305
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
64 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Locations
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Merck Sharp & Dohme B.V.
Haarlem, , Netherlands
Countries
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References
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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.
Other Identifiers
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4305-035
Identifier Type: -
Identifier Source: org_study_id
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