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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Suvorexant; Zopiclone

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