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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578472
• Other study ID #: CR108056
• Secondary ID: 42847922EDI10112
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2015
• Last updated: March 23, 2016
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-42847922
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
• Zolpidem
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
• Placebo
Matching Placebo will be administered orally.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test	The SDLP will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.	up to 8 hours post-dose	No
Secondary	Mean Lateral Position (MLP) Assessed From an On-road Driving Test	The MLP will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.	2 to 8 hours post-dose	No
Secondary	Distance-keeping Assessed From an On-road Driving Test	Distance-keeping will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.	2 to 8 hours post-dose	No
Secondary	Mean Speed (MS) Assessed From an On-road Driving Test	The MS will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.	2 to 8 hours post-dose	No
Secondary	Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test	The SDS will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.	2 to 8 hours post-dose	No
Secondary	Number of Head movements Assessed From an On-road Driving Test	Number of head movements will be measured from a simulated road tracking test over about 15 minutes. Instructed speed is 100 kilometer (km)/hour.	2 to 8 hours post-dose	No
Secondary	Reaction-time Assessed From an On-road Driving Test	Reaction-time will be assessed by 10 minutes of special and unexpected traffic events.	2 to 8 hours post-dose	No
Secondary	Inhibition-time Assessed From an On-road Driving Test	Inhibition-time will be assessed by 10 minutes of special and unexpected traffic events.	2 to 8 hours post-dose	No
Secondary	Alertness-time Assessed From an On-road Driving Test	Alertness-time will be assessed by 10 minutes of special and unexpected traffic events.	2 to 8 hours post-dose	No
Secondary	Drive safety Score (DSS)	The DSS is a composite score of driving simulator behavior ranging from 0-10, related to actual driving performance.	2 to 8 hours post-dose	No
Secondary	Subjective assessment of driving performance using visual analog scale	Participants indicated the perceived quality of their driving performance on a visual analog scale, which ranged from 0 ('I drove exceptionally poorly') to 20 ('I drove exceptionally well') around a midpoint of 'I drove normally'.	2 to 8 hours post-dose	No
Secondary	Computerized Cognitive Test Battery: Detection (DET) Test	Simple reaction time task measuring processing speed; mean of the log10 transformed reaction times for correct responses (lower score = better performance).	2 to 8 hours post-dose	No
Secondary	Computerized Cognitive Test Battery: Identification (IDN) Test	Choice reaction time paradigm measuring attention; mean of the log10 transformed reaction times for correct responses (lower score = better performance).	2 to 8 hours post-dose	No
Secondary	Computerized Cognitive Test Battery: One Back (OBK) Test	Working memory measure; mean of the log10 transformed reaction times for correct responses (lower score = better performance).	2 to 8 hours post-dose	No
Secondary	Computerized Cognitive Test Battery: One card learning	A visual recall test scored using arcsine transformation of the proportion of correct responses.	2 to 8 hours post-dose	No
Secondary	Computerized Cognitive Test Battery: Trailmaking Test Form B (TMT-B)	TMT-B is a paper-and-pencil measure of divided attention and executive function (tracking, sequencing). The participant is instructed do draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters. The participant is instructed to work as quickly as possible while still maintaining accuracy. The test requires approximately 2 minutes to complete, alternate forms are available. Scores include time to completion and errors.	2 to 8 hours post-dose	No
Secondary	Postural Stability Test	Postural stability will be measured by body sway meter which allows measurement of body movements in a single plane. Body sway is measured with a pot string meter (celesco) based on the Wright ataxiameter (Wright, 1971). With a string attached to the waist, all body movements over a period of time are integrated and expressed as millimeter sway. The total period of body sway measurement will be two minutes.	2 to 8 hours post-dose	No
Secondary	Karolinska Sleepiness Scale (KSS) Score	The KSS is a participant-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep).	2 to 8 hours post-dose	No
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	up to Follow-up (7-10 days after last dose of study drug)	Yes
Secondary	Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922	Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922 will be reported.	Pre-dose and Day 1 post-dose	No