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

NCT ID: NCT02578472

Last Updated: 2016-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-02-29

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 (Sequence ABC)

Participants will receive Treatment A (2 capsules of 20 milligram \[mg\] JNJ-42847922) in Period 1, Treatment B (10 mg zolpidem and 1 placebo capsule) in Period 2 and Treatment C (2 placebo capsules) in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing.

Group Type: EXPERIMENTAL

JNJ-42847922

Intervention Type: DRUG

JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule\*20 mg) in one of the treatment periods.

Zolpidem

Intervention Type: DRUG

Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.

Placebo

Intervention Type: DRUG

Matching Placebo will be administered orally.

Group 2 (Sequence BCA)

Participants will receive Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing.

Group Type: EXPERIMENTAL

JNJ-42847922

Intervention Type: DRUG

JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule\*20 mg) in one of the treatment periods.

Zolpidem

Intervention Type: DRUG

Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.

Placebo

Intervention Type: DRUG

Matching Placebo will be administered orally.

Group 3 (Sequence CAB)

Participants will receive Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing.

Group Type: EXPERIMENTAL

JNJ-42847922

Intervention Type: DRUG

JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule\*20 mg) in one of the treatment periods.

Zolpidem

Intervention Type: DRUG

Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.

Placebo

Intervention Type: DRUG

Matching Placebo will be administered orally.

Group 4 (Sequence ABC)

Participants will receive Treatment A in Period 1, Treatment B in Period 2 and Treatment C in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing.

Group Type: EXPERIMENTAL

JNJ-42847922

Intervention Type: DRUG

JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule\*20 mg) in one of the treatment periods.

Zolpidem

Intervention Type: DRUG

Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.

Placebo

Intervention Type: DRUG

Matching Placebo will be administered orally.

Group 5 (Sequence BCA)

Participants will receive Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing.

Group Type: EXPERIMENTAL

JNJ-42847922

Intervention Type: DRUG

JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule\*20 mg) in one of the treatment periods.

Zolpidem

Intervention Type: DRUG

Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.

Placebo

Intervention Type: DRUG

Matching Placebo will be administered orally.

Group 6 (Sequence CAB)

Participants will receive Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 with a washout interval of at least 3 days between treatment periods. Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing.

Group Type: EXPERIMENTAL

JNJ-42847922

Intervention Type: DRUG

JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule\*20 mg) in one of the treatment periods.

Zolpidem

Intervention Type: DRUG

Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.

Placebo

Intervention Type: DRUG

Matching Placebo will be administered orally.

Interventions

JNJ-42847922

JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule\*20 mg) in one of the treatment periods.

Intervention Type: DRUG

Zolpidem

Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.

Intervention Type: DRUG

Placebo

Matching Placebo will be administered orally.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

42847922EDI1011

Identifier Type: OTHER

Identifier Source: secondary_id

2015-004203-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108056

Identifier Type: -

Identifier Source: org_study_id