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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014