NCT00798395CompletedPhase 1
A Randomized Double-blind, Placebo-controlled, 4-period Cross-over Study to Assess the Effect of Single and Multiple Doses of 1.5 mg and 4.5 mg Org 50081 and a Single Dose of 7.5 mg Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 32
- Primary Endpoint
- The Standard Deviation of Lateral Position
Study Overview
Brief Summary
This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject has at least 3 years of car driving experience
- •Subject signs the trial Informed Consent Form
- •Subject is in a healthy condition as judged by the investigator
- •Subject has a regular sleep pattern
Exclusion Criteria
- •Subject has insomnia or any other sleep disorder
- •Medication or drug use of any kind prior to the study
- •Relevant history or presence of a significant medical illness
Arms & Interventions
Treatment 1
Experimental
Intervention: Org 50081 (Drug)
Treatment 2
Experimental
Intervention: Org 50081 (Drug)
Treatment 3
Placebo Comparator
Intervention: Placebo (Drug)
Treatment 4
Active Comparator
Intervention: zopiclone (Drug)
Outcomes
Primary Outcomes
The Standard Deviation of Lateral Position
Time Frame: Day 8
Secondary Outcomes
- Psychomotor and cognitive performance tasks(Day 8)
Investigators
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