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Completed

NCT Number: NCT01311882

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

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Merck Sharp & Dohme B.V.

Haarlem, 2031 BN, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-4305 40 mg

Drug

4 x 10 mg MK-4305 tablets

MK-4305 20 mg

Drug

2 x 10 mg MK-4305 tablets

Zopiclone

Drug

1 x 7.5 mg Zopiclone tablet

Other names: Zimovane

Grossly Matching Placebo for Zopiclone

Drug

Grossly Matching Placebo for Zopiclone

Matching Placebo for MK-4305

Drug

Matching Placebo for MK-4305

Primary outcomes

  1. Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo

    Time frame: Day 2

Secondary outcomes

  1. Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo

    Time frame: Day 2

  2. Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo

    Time frame: Day 9

  3. Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo

    Time frame: Day 9

  4. Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo)

    Time frame: Day 2 and Day 9

  5. Word learning test (MK-4305 versus placebo)

    Time frame: Day 2 and Day 9

  6. 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

  7. Number of participants with adverse events

    Time frame: Up to 14 days after last dose

  8. Number of participants discontinued from study due to adverse events

    Time frame: Up to 14 days after last dose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2011
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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