A multiple dose study to evaluate next day effects of MK-4305 on driving performance in healthy non-elderly subjects

A multiple dose study to evaluate next day effects of MK-4305 on driving performance in healthy non-elderly subjects - Driving study with MK-4305 in non-elderly subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35772

Enrollment

Registered

2010-02-11

Start date

2011-05-20

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

onderzoek betreft gezonde vrijwilligers insomnia

Interventions

In each of the 4 treatment periods the volunteers will receive 1 of the following treatments: - 20 mg MK-4305 on day 1 till 8 before going to sleep - 40 mg MK-4305 on day 1 till 8 before going to s

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Use of medication that may influence driving performance Excessive use of alcohol, nicotine or cafeine Use of drugs For women: pregnancy

Design outcomes

Primary

Measure	Time frame
The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on SDLP after a single dose. The abbreviation SDLP is Standard Deviation of Lateral Position (in cm). This is an index of weaving of the car on the road.	—

Secondary

Measure	Time frame
- The mean treatment difference between zopiclone (7,5 mg) and placebo on SDLP after a single dose. - The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on SDLP after 8 days of dosing. - The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on SDS after 1 and 8 days of dosing. - The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on memory (Verbal Learning Task) and balance (Body Sway) after 1 and 8 days of dosing. - To evaluate the safety and tolerability of MK-4305 (20 and 40 mg) after 1 and 8 days of dosing. The abbreviation SDS is Standard Deviation of Speed (in km/hr). This is an index of how well a constant speed can be maintained.	—

Measure

Time frame

- The mean treatment difference between zopiclone (7,5 mg) and placebo on SDLP after a single dose. - The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on SDLP after 8 days of dosing. - The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on SDS after 1 and 8 days of dosing. - The mean treatment difference between MK-4305 (20 and 40 mg) and placebo on memory (Verbal Learning Task) and balance (Body Sway) after 1 and 8 days of dosing. - To evaluate the safety and tolerability of MK-4305 (20 and 40 mg) after 1 and 8 days of dosing. The abbreviation SDS is Standard Deviation of Speed (in km/hr). This is an index of how well a constant speed can be maintained.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)