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

February 19, 2016 updated by: Merck Sharp & Dohme LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
Time Frame: Day 2
Day 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo
Time Frame: Day 2
Day 2
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
Time Frame: Day 9
Day 9
Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo
Time Frame: Day 9
Day 9
Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo)
Time Frame: Day 2 and Day 9
Day 2 and Day 9
Word learning test (MK-4305 versus placebo)
Time Frame: Day 2 and Day 9
Day 2 and Day 9
Body sway area: Area of the 95% confidence ellipse enclosing the center of pressure (A95) (MK-4305 versus placebo)
Time Frame: Day 2 and Day 9
Day 2 and Day 9
Number of participants with adverse events
Time Frame: Up to 14 days after last dose
Up to 14 days after last dose
Number of participants discontinued from study due to adverse events
Time Frame: Up to 14 days after last dose
Up to 14 days after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4305-035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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