NCT02578472

Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Participants

A Double-blind, Randomized, Controlled, 3-way Crossover, Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the effects of JNJ-42847922, compared to zolpidem and placebo, on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) after forced awakening using a validated driving simulator test at 2, 4, 6 and 8 hours post-evening dose.

Detailed description

This is a single center, double-blind (neither Investigator nor participant knows which treatment the participant receives), randomized (study drug assigned by chance), 3-way cross-over (the same medications provided to all participants but in different sequence), pilot study in healthy male and female participants. Participants will be randomly assigned to 1 of 6 treatment and planning sequences. The study will consist of 3 parts: Screening Phase (between 21 days and 1 day prior to the first dose administration), a 3-way crossover double-blind, single dose treatment Phase and follow-up Phase (7 to 10 days after last dose administration). The maximum study duration for each participant will not exceed 7 weeks. The double-blind crossover treatment phase will consist of 3 treatment periods separated by a washout period of at least 3 days between dosing. Participants will receive either Treatment A (2 capsules of 20 milligram \[mg\] JNJ-42847922), Treatment B (10 mg zolpidem and 1 placebo capsule) or Treatment C (2 placebo capsules) in each treatment period. Driving performance will be assessed primarily by the mean difference of standard deviation of lateral position (SDLP) from an on road driving test. Participants' safety will be monitored throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-42847922	JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule\*20 mg) in one of the treatment periods.
DRUG	Zolpidem	Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
DRUG	Placebo	Matching Placebo will be administered orally.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-10-19
• Last updated: 2016-03-24

Locations

1 site across 1 country: Netherlands