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

NCT02578472 | Completed Phase 1

• 3 other identifiers: CR10805642847922EDI10112015-004203-24
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; JNJ-42847922; zolpidem; Placebo

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (19)

• Mean Lateral Position (MLP) Assessed From an On-road Driving Test

  2 to 8 hours post-dose

• Distance-keeping Assessed From an On-road Driving Test

  2 to 8 hours post-dose

• Mean Speed (MS) Assessed From an On-road Driving Test

  2 to 8 hours post-dose

• Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test

  2 to 8 hours post-dose

• Number of Head movements Assessed From an On-road Driving Test

  2 to 8 hours post-dose

Study Arms (6)

Group 1 (Sequence ABC)

EXPERIMENTAL

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.

Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo

Group 2 (Sequence BCA)

EXPERIMENTAL

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.

Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo

Group 3 (Sequence CAB)

EXPERIMENTAL

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.

Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo

Group 4 (Sequence ABC)

EXPERIMENTAL

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.

Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo

Group 5 (Sequence BCA)

EXPERIMENTAL

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.

Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo

Group 6 (Sequence CAB)

EXPERIMENTAL

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.

Drug: JNJ-42847922; Drug: Zolpidem; Drug: Placebo

Interventions

JNJ-42847922 DRUG

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

Group 1 (Sequence ABC); Group 2 (Sequence BCA); Group 3 (Sequence CAB); Group 4 (Sequence ABC); Group 5 (Sequence BCA); Group 6 (Sequence CAB)

Zolpidem DRUG

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

Group 1 (Sequence ABC); Group 2 (Sequence BCA); Group 3 (Sequence CAB); Group 4 (Sequence ABC); Group 5 (Sequence BCA); Group 6 (Sequence CAB)

Placebo DRUG

Matching Placebo will be administered orally.

Group 1 (Sequence ABC); Group 2 (Sequence BCA); Group 3 (Sequence CAB); Group 4 (Sequence ABC); Group 5 (Sequence BCA); Group 6 (Sequence CAB)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (1)

Unknown Facility

Leiden, Netherlands

Location

MeSH Terms

Interventions

seltorexant; Zolpidem

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 24, 2016

Record last verified: 2016-03

Locations

NL (1)