A multiple dose study to evaluate next day effects of MK-4305 on driving performance in healthy non-elderly subjects
Completed
- Conditions
- 10040998onderzoek betreft gezonde vrijwilligersinsomniasleeplessness
- Registration Number
- NL-OMON35772
- Lead Sponsor
- Merck Sharp & Dohme (MSD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
Healthy
Age 21 till 64 (inclusive)
Possession of valid driving licence
Sufficient driving experience (at least 5000 km/year over the past 3 years)
Exclusion Criteria
Use of medication that may influence driving performance
Excessive use of alcohol, nicotine or cafeine
Use of drugs
For women: pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on<br /><br>SDLP after a single dose.<br /><br>The abbreviation SDLP is Standard Deviation of Lateral Position (in cm). This<br /><br>is an index of weaving of the car on the road.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- The mean treatment difference between zopiclone (7,5 mg) and placebo on SDLP<br /><br>after a single dose.<br /><br>- The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on<br /><br>SDLP after 8 days of dosing.<br /><br>- The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on<br /><br>SDS after 1 and 8 days of dosing.<br /><br>- The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on<br /><br>memory (Verbal Learning Task) and balance (Body Sway) after 1 and 8 days of<br /><br>dosing.<br /><br>- To evaluate the safety and tolerability of MK-4305 (20 and 40 mg) after 1 and<br /><br>8 days of dosing.<br /><br>The abbreviation SDS is Standard Deviation of Speed (in km/hr). This is an<br /><br>index of how well a constant speed can be maintained.</p><br>