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

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

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

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: MK-4305 40 mg; Drug: Grossly Matching Placebo for Zopiclone; Drug: MK-4305 20 mg; Drug: Matching Placebo for MK-4305; Drug: Zopiclone

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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: Grossly Matching Placebo for Zopiclone; Grossly Matching Placebo for Zopiclone; Drug: MK-4305 20 mg; 2 x 10 mg MK-4305 tablets; 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: Matching Placebo for MK-4305; Matching Placebo for MK-4305; Drug: Zopiclone; 1 x 7.5 mg Zopiclone tablet; Other Names: Zimovane
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo	Day 2

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo	Day 2
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo	Day 9
Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo	Day 9
Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo)	Day 2 and Day 9
Word learning test (MK-4305 versus placebo)	Day 2 and Day 9
Body sway area: Area of the 95% confidence ellipse enclosing the center of pressure (A95) (MK-4305 versus placebo)	Day 2 and Day 9
Number of participants with adverse events	Up to 14 days after last dose
Number of participants discontinued from study due to adverse events	Up to 14 days after last dose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: March 8, 2011
• First Submitted That Met QC Criteria: March 8, 2011
• First Posted (Estimate): March 10, 2011

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: February 19, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; Sleep Aids, Pharmaceutical; Orexin Receptor Antagonists; Suvorexant; Zopiclone
• Other Study ID Numbers: 4305-035