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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Insomnia

Treatments

Drug: Grossly Matching Placebo for Zopiclone

Drug: Zopiclone

Drug: MK-4305 20 mg

Drug: MK-4305 40 mg

Drug: Matching Placebo for MK-4305

Study type

Interventional

Funder types

Industry

Identifiers

NCT01311882

4305-035

Details and patient eligibility

About

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

Enrollment

28 patients

Sex

All

Ages

21 to 64 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

28 participants in 4 patient groups, including a placebo group

MK-4305 40 mg

Experimental group

Description:

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

Treatment:

Drug: Grossly Matching Placebo for Zopiclone

Drug: MK-4305 40 mg

MK-4305 20 mg

Experimental group

Description:

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

Treatment:

Drug: MK-4305 20 mg

Drug: Grossly Matching Placebo for Zopiclone

Drug: Matching Placebo for MK-4305

Zopiclone 7.5 mg

Active Comparator group

Description:

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

Treatment:

Drug: Matching Placebo for MK-4305

Drug: Zopiclone

Placebo