Clincosm LogoSign in Get a demo

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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01311882
Collaborator
(none)
28
Enrollment
1
Location
4
Arms
7
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: MK-4305 40 mg
  • Drug: MK-4305 20 mg
  • Drug: Zopiclone
  • Drug: Grossly Matching Placebo for Zopiclone
  • Drug: Matching Placebo for MK-4305
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multiple Dose Study to Evaluate Next Day Effects of MK-4305 on Driving Performance in Healthy Non-Elderly Subjects
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: MK-4305 40 mg
4 x 10 mg MK-4305 tablets

Drug: Grossly Matching Placebo for Zopiclone
Grossly Matching Placebo for Zopiclone
Experimental: 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

Drug: MK-4305 20 mg
2 x 10 mg MK-4305 tablets

Drug: Grossly Matching Placebo for Zopiclone
Grossly Matching Placebo for Zopiclone

Drug: Matching Placebo for MK-4305
Matching Placebo for MK-4305
Active Comparator: 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

Drug: Zopiclone
1 x 7.5 mg Zopiclone tablet
Other Names:
  • Zimovane

    • Drug: Matching Placebo for MK-4305
    Matching Placebo for MK-4305
    Placebo Comparator: 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

    Drug: Grossly Matching Placebo for Zopiclone
    Grossly Matching Placebo for Zopiclone

    Drug: Matching Placebo for MK-4305
    Matching Placebo for MK-4305

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo [Day 2]

    2. Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo [Day 9]

    3. Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo [Day 9]

    4. Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo) [Day 2 and Day 9]

    5. Word learning test (MK-4305 versus placebo) [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) [Day 2 and Day 9]

    7. Number of participants with adverse events [Up to 14 days after last dose]

    8. Number of participants discontinued from study due to adverse events [Up to 14 days after last dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Merck Sharp & Dohme B.V. Haarlem Netherlands 2031 BN

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT01311882
    Other Study ID Numbers:
    • 4305-035
    First Posted:
    Mar 10, 2011
    Last Update Posted:
    Feb 22, 2016
    Last Verified:
    Feb 1, 2016
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Zopiclone
    Suvorexant

    Study Results

    No Results Posted as of Feb 22, 2016