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)

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

Completed

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Org 50081

Drug

1.5 mg on day 1-7

Placebo

Drug

Once daily on Day 1-7

Zopiclone

Drug

Single dose of 7.5 mg

Primary outcomes

The Standard Deviation of Lateral Position

Time frame: Day 8

Secondary outcomes

Psychomotor and cognitive performance tasks

Time frame: Day 8

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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.

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Nov 26, 2008
Registry last updated: Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed