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)

Merck Sharp & Dohme LLC32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sleep Initiation and Maintenance Disorders Mental Disorders

Interventions

Org 50081DRUG

1.5 mg on day 1-7

Org 50081DRUG

4.5 mg on Day 1-7

PlaceboDRUG

Once daily on Day 1-7

zopiclone

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The Standard Deviation of Lateral Position

Time frame: Day 8

Secondary Outcomes

Psychomotor and cognitive performance tasks

Time frame: Day 8

Data from ClinicalTrials.gov

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