A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)

Phase 1

Completed

• Conditions: Mental Disorders; Sleep Initiation and Maintenance Disorders
• Interventions: Drug: Placebo; Drug: Org 50081; Drug: zopiclone

• Registration Number: NCT00798395
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-12
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment 3	Placebo	-
Treatment 1	Org 50081	-
Treatment 2	Org 50081	-
Treatment 4	zopiclone	-

Primary Outcome Measures

Name	Time	Method
The Standard Deviation of Lateral Position	Day 8

Secondary Outcome Measures

Name	Time	Method
Psychomotor and cognitive performance tasks	Day 8