Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
JNJ-42847922
zolpidem
Placebo
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2015-10-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) (weight \[kg\]/height\^2\[m\^2\]) between 18 and 30 kg/m\^2 (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 pre-dose 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:

* 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) (DSM-5) 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

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
timeFrame: up to 8 hours post-dose
Secondary outcomes:
measure: Mean Lateral Position (MLP) Assessed From an On-road Driving Test
timeFrame: 2 to 8 hours post-dose
measure: Distance-keeping Assessed From an On-road Driving Test
timeFrame: 2 to 8 hours post-dose
measure: Mean Speed (MS) Assessed From an On-road Driving Test
timeFrame: 2 to 8 hours post-dose
measure: Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test
timeFrame: 2 to 8 hours post-dose
measure: Number of Head movements Assessed From an On-road Driving Test
timeFrame: 2 to 8 hours post-dose
measure: Reaction-time Assessed From an On-road Driving Test
timeFrame: 2 to 8 hours post-dose
measure: Inhibition-time Assessed From an On-road Driving Test
timeFrame: 2 to 8 hours post-dose
measure: Alertness-time Assessed From an On-road Driving Test
timeFrame: 2 to 8 hours post-dose
measure: Drive safety Score (DSS)
timeFrame: 2 to 8 hours post-dose
measure: Subjective assessment of driving performance using visual analog scale
timeFrame: 2 to 8 hours post-dose
measure: Computerized Cognitive Test Battery: Detection (DET) Test
timeFrame: 2 to 8 hours post-dose
measure: Computerized Cognitive Test Battery: Identification (IDN) Test
timeFrame: 2 to 8 hours post-dose
measure: Computerized Cognitive Test Battery: One Back (OBK) Test
timeFrame: 2 to 8 hours post-dose
measure: Computerized Cognitive Test Battery: One card learning
timeFrame: 2 to 8 hours post-dose
measure: Computerized Cognitive Test Battery: Trailmaking Test Form B (TMT-B)
timeFrame: 2 to 8 hours post-dose
measure: Postural Stability Test
timeFrame: 2 to 8 hours post-dose
measure: Karolinska Sleepiness Scale (KSS) Score
timeFrame: 2 to 8 hours post-dose
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: up to Follow-up (7-10 days after last dose of study drug)
measure: Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922
timeFrame: Pre-dose and Day 1 post-dose
Other outcomes:
Locations:
city: Leiden
country: Netherlands
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: