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

NCT01311882 | Completed Phase 1

• 1 other identifier: 4305-035
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo

  Day 2

Secondary Outcomes (8)

• 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

Study Arms (4)

MK-4305 40 mg

EXPERIMENTAL

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

MK-4305 20 mg

EXPERIMENTAL

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

Zopiclone 7.5 mg

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

MK-4305 40 mg DRUG

4 x 10 mg MK-4305 tablets

MK-4305 40 mg

MK-4305 20 mg DRUG

2 x 10 mg MK-4305 tablets

MK-4305 20 mg

Zopiclone DRUG

1 x 7.5 mg Zopiclone tablet

Also known as: Zimovane

Zopiclone 7.5 mg

Grossly Matching Placebo for Zopiclone DRUG

Grossly Matching Placebo for Zopiclone

MK-4305 20 mg; MK-4305 40 mg; Placebo

Matching Placebo for MK-4305 DRUG

Matching Placebo for MK-4305

MK-4305 20 mg; Placebo; Zopiclone 7.5 mg

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Merck Sharp & Dohme B.V.

Haarlem, 2031 BN, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 26039969 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

suvorexant; zopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

NL (1)