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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311882
• Other study ID #: 4305-035
• Status: Completed
• Phase: Phase 1
• First received: March 8, 2011
• Last updated: February 19, 2016
• Start date: April 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• MK-4305 40 mg
4 x 10 mg MK-4305 tablets
• MK-4305 20 mg
2 x 10 mg MK-4305 tablets
• Zopiclone
1 x 7.5 mg Zopiclone tablet
• Grossly Matching Placebo for Zopiclone
Grossly Matching Placebo for Zopiclone
• Matching Placebo for MK-4305
Matching Placebo for MK-4305

Locations

Country	Name	City	State
Netherlands	Merck Sharp & Dohme B.V.	Haarlem

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo		Day 2	No
Secondary	Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo		Day 2	No
Secondary	Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo		Day 9	No
Secondary	Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo		Day 9	No
Secondary	Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo)		Day 2 and Day 9	No
Secondary	Word learning test (MK-4305 versus placebo)		Day 2 and Day 9	No
Secondary	Body sway area: Area of the 95% confidence ellipse enclosing the center of pressure (A95) (MK-4305 versus placebo)		Day 2 and Day 9	No
Secondary	Number of participants with adverse events		Up to 14 days after last dose	Yes
Secondary	Number of participants discontinued from study due to adverse events		Up to 14 days after last dose	Yes