Depression Insomnia
Conditions
Interventions
On Day 1 of each study period, subjects will take the study medication 15
minutes prior to bedtime, The dose of the study medication is: JNJ-42847922: 2
capsules containing 20 mg JNJ-42847922 each
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -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)
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effects of JNJ-42847922, zolpidem and placebo on driving performance as assessed by the Mean Lateral Position (MLP), distance-keeping, mean speed, SD of speed, head movement, reaction-time, inhibition, alertness and Drive safety Score (DSS) after forced awakening using a validated driving simulator test at 2, 4, 6 and 8 hours post-evening dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effects of JNJ-42847922, zolpidem and placebo on the subjective driving performance of the subjects after the driving simulator test at 2, 4, 6 and 8 hours postevening dose. To evaluate the effects of JNJ-42847922, zolpidem and placebo on a cognitive test battery at 2, 4, 6 and 8 hours post-evening dose. To evaluate the effects of JNJ-42847922, zolpidem and placebo on sleepiness at 2, 4, 6 and 8 hours post-evening dose using the Karolinska Sleepiness Scale (KSS). To evaluate the effects of JNJ-42847922, zolpidem and placebo on postural stability (body sway) at 2, 4, 6 and 8 hours post-evening dose. To investigate the safety and tolerability of 40 mg JNJ-42847922 in healthy subjects. To evaluate the potential relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922, its metabolites M12 and M16, and zolpidem. | — |
Countries
Netherlands
Outcome results
None listed