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
- Conditions
- DepressionInsomnia10040991
- Registration Number
- NL-OMON42615
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
-Body mass index (BMI) (weight [kg]/height2[m2]) between 18 and 30 kg/m2 (inclusive)
-Men who are sexually active with a woman of childbearing potential must agree to use a condom, and all men must not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, for men who have not had a vasectomy, their female partners should also use an appropriate method of birth control for at least the same duration
-A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test predose on Day 1 of each period
-A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug
-Participant has a valid driving license for more than 3 years, has driven at least 5000 kilometer (km) in the past year and is driving a car regularly
- Women of childbearing potential must practice a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies (that is, one that results in a less than 1 percent per year failure rate when used consistently and correctly)
-Participant has clinically significant liver or renal insufficiency* cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including cataplexy and cognitive
impairment), hematologic, rheumatologic, psychiatric, or metabolic disturbances. A significant primary sleep disorder is exclusionary
-Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
- Subject has a history of substance or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM5) criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse (opiates [including methadone], cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy and benzodiazepines) at screening or admission on Day 1 of each study period
- Current suicidal or homicidal ideation/intent/behavior
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or Human immunodeficiency virus (HIV) antibodies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the effects of JNJ-42847922, zolpidem and placebo on driving<br /><br>performance<br /><br>as assessed by the Mean Lateral Position (MLP), distance-keeping, mean speed,<br /><br>SD of<br /><br>speed, head movement, reaction-time, inhibition, alertness and Drive safety<br /><br>Score (DSS)<br /><br>after forced awakening using a validated driving simulator test at 2, 4, 6 and<br /><br>8 hours<br /><br>post-evening dose.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the effects of JNJ-42847922, zolpidem and placebo on the subjective<br /><br>driving performance of the subjects after the driving simulator test at 2, 4, 6<br /><br>and 8 hours postevening dose.<br /><br>To evaluate the effects of JNJ-42847922, zolpidem and placebo on a cognitive<br /><br>test battery at 2, 4, 6 and 8 hours post-evening dose.<br /><br>To evaluate the effects of JNJ-42847922, zolpidem and placebo on sleepiness at<br /><br>2, 4, 6 and 8 hours post-evening dose using the Karolinska Sleepiness Scale<br /><br>(KSS).<br /><br>To evaluate the effects of JNJ-42847922, zolpidem and placebo on postural<br /><br>stability (body sway) at 2, 4, 6 and 8 hours post-evening dose.<br /><br>To investigate the safety and tolerability of 40 mg JNJ-42847922 in healthy<br /><br>subjects.<br /><br>To evaluate the potential relationship between duration of changes in driving<br /><br>ability and plasma concentrations of JNJ-42847922, its metabolites M12 and M16,<br /><br>and zolpidem.</p><br>