MedDataX Logo

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

NCT ID: NCT02228239

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Healthy Esketamine Mirtazapine Psychomotor.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

Esketamine 84 milligram (mg) \[3\*1 of spray in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Mirtazapine

Intervention Type DRUG

Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.

Placebo (Matched to Esketamine)

Intervention Type DRUG

Placebo \[3\*1 in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Placebo (Matched to Mirtazapine)

Intervention Type DRUG

Placebo capsule will be administered orally on Day 1 in one of the treatment periods.

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

Esketamine 84 milligram (mg) \[3\*1 of spray in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Mirtazapine

Intervention Type DRUG

Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.

Placebo (Matched to Esketamine)

Intervention Type DRUG

Placebo \[3\*1 in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Placebo (Matched to Mirtazapine)

Intervention Type DRUG

Placebo capsule will be administered orally on Day 1 in one of the treatment periods.

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

Esketamine 84 milligram (mg) \[3\*1 of spray in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Mirtazapine

Intervention Type DRUG

Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.

Placebo (Matched to Esketamine)

Intervention Type DRUG

Placebo \[3\*1 in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Placebo (Matched to Mirtazapine)

Intervention Type DRUG

Placebo capsule will be administered orally on Day 1 in one of the treatment periods.

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

Esketamine 84 milligram (mg) \[3\*1 of spray in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Mirtazapine

Intervention Type DRUG

Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.

Placebo (Matched to Esketamine)

Intervention Type DRUG

Placebo \[3\*1 in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Placebo (Matched to Mirtazapine)

Intervention Type DRUG

Placebo capsule will be administered orally on Day 1 in one of the treatment periods.

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

Esketamine 84 milligram (mg) \[3\*1 of spray in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Mirtazapine

Intervention Type DRUG

Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.

Placebo (Matched to Esketamine)

Intervention Type DRUG

Placebo \[3\*1 in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Placebo (Matched to Mirtazapine)

Intervention Type DRUG

Placebo capsule will be administered orally on Day 1 in one of the treatment periods.

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

Esketamine 84 milligram (mg) \[3\*1 of spray in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Mirtazapine

Intervention Type DRUG

Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.

Placebo (Matched to Esketamine)

Intervention Type DRUG

Placebo \[3\*1 in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Placebo (Matched to Mirtazapine)

Intervention Type DRUG

Placebo capsule will be administered orally on Day 1 in one of the treatment periods.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Mirtazapine

Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.

Intervention Type DRUG

Placebo (Matched to Esketamine)

Placebo \[3\*1 in each nostril\] will be administered intranasally on Day 1 in one of the treatment periods.

Intervention Type DRUG

Placebo (Matched to Mirtazapine)

Placebo capsule will be administered orally on Day 1 in one of the treatment periods.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

JNJ-54135419

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Leiden, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-002005-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ESKETINTRD1006

Identifier Type: OTHER

Identifier Source: secondary_id

CR104764

Identifier Type: -

Identifier Source: org_study_id