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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01311882
First received: March 8, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Insomnia
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo [ Time Frame: Day 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo [ Time Frame: Day 9 ] [ Designated as safety issue: No ]
  • Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo [ Time Frame: Day 9 ] [ Designated as safety issue: No ]
  • Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo) [ Time Frame: Day 2 and Day 9 ] [ Designated as safety issue: No ]
  • Word learning test (MK-4305 versus placebo) [ Time Frame: Day 2 and Day 9 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Up to 14 days after last dose ] [ Designated as safety issue: Yes ]
  • Number of participants discontinued from study due to adverse events [ Time Frame: Up to 14 days after last dose ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: April 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311882

Locations
Netherlands
Merck Sharp & Dohme B.V.
Haarlem, Netherlands, 2031 BN
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01311882     History of Changes
Other Study ID Numbers: 4305-035
Study First Received: March 8, 2011
Last Updated: September 17, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Zopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014