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CompletedNCT01311882Updated Feb 22, 2016

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

A Phase 1 interventional study of MK-4305 40 mg and MK-4305 20 mg in Insomnia, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in Netherlands. Open to participants aged 21 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-22.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
21 Years to 64 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Insomnia
03

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 64 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • 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 · Drug: 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 · Drug: Grossly Matching Placebo for Zopiclone · Drug: 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 · Drug: 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 · Drug: Matching Placebo for MK-4305

Interventions

  • DrugMK-4305 40 mg

    4 x 10 mg MK-4305 tablets

  • DrugMK-4305 20 mg

    2 x 10 mg MK-4305 tablets

  • DrugZopiclone

    1 x 7.5 mg Zopiclone tablet

    Also known as: Zimovane

  • DrugGrossly Matching Placebo for Zopiclone

    Grossly Matching Placebo for Zopiclone

  • DrugMatching Placebo for MK-4305

    Matching Placebo for MK-4305

06

What researchers measure

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

07

Study locations

1 site
  • Merck Sharp & Dohme B.V.
    Haarlem, 2031 BN, Netherlands
08

References and documents

Publications

  • 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. PubMed 26039969 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01311882
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Mar 10, 2011
Start date
Apr 2011
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Feb 22, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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