Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants (DRiVESaFe)

December 29, 2014 updated by: Janssen Research & Development, LLC

A Double-blind, Randomized, Placebo-Controlled, 3-way Crossover Study to Evaluate the Single Dose Effects of Intranasal Esketamine on Safety of On-Road Driving in Healthy Subjects

The purpose of this study is to evaluate the effect of esketamine compared to placebo on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test in healthy participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 1, randomized (study medication assigned to participants by chance), double-blind (neither Investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), single-center, single-dose and 3-way crossover (the same medications provided to all participants but in different sequence) study of esketamine in healthy participants. Participants will be randomly assigned to 1 of 6 treatment 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 (45 days) and follow-up Phase (7 to 10 days after last dose administration). The maximum study duration for each participant will not exceed 7 weeks. Participants will receive either Treatment A (esketamine 84 milligram (mg) intranasal and 1 placebo capsule), Treatment B (placebo intranasal and 1 mirtazapine 30 mg capsule) or Treatment C (placebo intranasal and placebo capsule) in each treatment period. Driving performance will be assessed primarily by the mean difference of SDLP from an on road driving test. Participants' safety will be monitored throughout the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI) (weight [kg]/height^2[m^2]) between 18 and 30 kg/m^2 (inclusive), and body weight not less than 45 kg
  • Blood pressure (after the participants is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at Screening and pre-dose on Day 1 of Period 1
  • A woman of childbearing potential must have a negative urine pregnancy test at Screening and pre-dose on Day 1 of Period 1
  • A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at Screening and pre-dose on Day 1 of Period 1, including: sinus rhythm, heart rate between 45 and 90 beats per minute (bpm), QTc interval less than or equal to 450 milliseconds (ms), QRS interval of less than 120 ms, PR interval less than 200 ms and morphology consistent with healthy cardiac conduction and function 1st degree AV block is exclusionary
  • 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

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
  • Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at Screening or on Day 1 of Period 1, as deemed appropriate by the Investigator
  • Anatomical or medical conditions that may impede delivery or absorption of study medication (for example, undergone facial reconstruction, rhinoplasty, significant structural or functional abnormalities of the nose or upper airway; obstructions or mucosal lesions of the nostrils or nasal passages; undergone sinus surgery in the previous 2 years; or signs and symptoms of rhinitis predose on Day 1 of Period 1)
  • Has an abnormal or deviated nasal septum with any one or more of the following symptoms: blockage of one or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, frequent sinus infections, and at times has facial pain, headaches, and postnasal drip

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence 1 (ABC)
Participants will receive Treatment A (esketamine 84 milligram (mg) intranasally and 1 placebo capsule) in Period 1, Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 2 and Treatment C (placebo intranasally and placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
Drug: Esketamine
Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Other Names:
  • JNJ-54135419
Drug: Mirtazapine
Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Esketamine)
Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Mirtazapine)
Placebo capsule will be administered orally on Day 1 in one of the treatment periods.
Experimental: Sequence 2 (BCA)
Participants will receive Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 1, Treatment C (placebo intranasally and placebo capsule) in Period 2 and Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
Drug: Esketamine
Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Other Names:
  • JNJ-54135419
Drug: Mirtazapine
Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Esketamine)
Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Mirtazapine)
Placebo capsule will be administered orally on Day 1 in one of the treatment periods.
Experimental: Sequence 3 (CAB)
Participants will receive Treatment C (placebo intranasally and placebo capsule) in Period 1, Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 2 and Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
Drug: Esketamine
Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Other Names:
  • JNJ-54135419
Drug: Mirtazapine
Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Esketamine)
Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Mirtazapine)
Placebo capsule will be administered orally on Day 1 in one of the treatment periods.
Experimental: Sequence 4 (CBA)
Participants will receive Treatment C (placebo intranasally and placebo capsule) in Period 1, Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 2 and Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
Drug: Esketamine
Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Other Names:
  • JNJ-54135419
Drug: Mirtazapine
Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Esketamine)
Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Mirtazapine)
Placebo capsule will be administered orally on Day 1 in one of the treatment periods.
Experimental: Sequence 5 (ACB)
Participants will receive Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 1, Treatment C (placebo intranasally and placebo capsule) in Period 2 and Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
Drug: Esketamine
Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Other Names:
  • JNJ-54135419
Drug: Mirtazapine
Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Esketamine)
Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Mirtazapine)
Placebo capsule will be administered orally on Day 1 in one of the treatment periods.
Experimental: Sequence 6 (BAC)
Participants will receive Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 1, Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 2 and Treatment C (placebo intranasally and placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods.
Drug: Esketamine
Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Other Names:
  • JNJ-54135419
Drug: Mirtazapine
Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Esketamine)
Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Drug: Placebo (Matched to Mirtazapine)
Placebo capsule will be administered orally on Day 1 in one of the treatment periods.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
Time Frame: 4 to 14 hours post-dose
The SDLP will be measured from a validated on-road driving test in a 100 kilometer (km) highway-driving lane.
4 to 14 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test
Time Frame: 4 to 14 hours post-dose
The SDS will be measured from a validated on-road driving test in a 100 km highway-driving lane.
4 to 14 hours post-dose
Mean Speed (MS) Assessed From an On-road Driving Test
Time Frame: 4 to 14 hours post-dose
The MS will be measured from a validated on-road driving test in a 100 km highway-driving lane.
4 to 14 hours post-dose
Mean Lateral Position (MLP) Assessed From an On-road Driving Test
Time Frame: 4 to 14 hours post-dose
The MLP will be measured from a validated on-road driving test in a 100 km highway-driving lane.
4 to 14 hours post-dose
Subjective Driving Performance Score
Time Frame: After completion of driving test (4 to 14 hours post-dose)
Participants will indicate the perceived quality of their driving performance on a visual analog scale, which ranges from 0 ('I drove exceptionally poorly') to 20 ('I drove exceptionally well').
After completion of driving test (4 to 14 hours post-dose)
Karolinska Sleepiness Scale (KSS) Score
Time Frame: Pre-dose, 1, 2 hours and after completion of driving test (4 to 14 hours post-dose)
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).
Pre-dose, 1, 2 hours and after completion of driving test (4 to 14 hours post-dose)
Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time Frame: Up to 7 to 10 days after last dose administration
The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior developed to assess severity and track suicidal events providing a summary of both suicidal ideation and behavior to identify the level and type of suicidality present.
Up to 7 to 10 days after last dose administration
Brief Psychiatric Rating Scale (BPRS) Symptom Sub-Scale Score
Time Frame: Pre-dose, 1 and 2 hours post-dose
The BPRS is an 18-item rating scale which is used to assess a range of psychotic and affective symptoms rated from both observation of the participant and the participant's own report. Only the 4-item positive symptom subscale (consisting of: suspiciousness/persecution, hallucinations, unusual thought content, and conceptual disorganization) will be used and each question is rated on a 7-point scale ranging from 0 (not present) to 6 (extremely severe).
Pre-dose, 1 and 2 hours post-dose
Clinician Administered Dissociative States Scale (CADSS) Score
Time Frame: Pre-dose, 1 and 2 hours post-dose
The CADSS is an instrument for the measurement of present-state dissociative symptoms. The CADSS comprises 23 subjective items, divided into 3 components: Depersonalization, Derealization and Amnesia. Participant's responses are coded on a 5-point scale (0 = "Not at all" through to 4 = "Extremely").
Pre-dose, 1 and 2 hours post-dose
Maximum plasma concentration (Cmax)
Time Frame: Pre-dose, 0.5, 1, 3 and 4 hours post-dose
The Cmax is the maximum observed plasma concentration of esketamine or noresketamine.
Pre-dose, 0.5, 1, 3 and 4 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR104764
  • 2014-002005-38 (EudraCT Number)
  • ESKETINTRD1006 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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