Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants
Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Esketamine (Drug); Mirtazapine (Drug); Placebo (Matched to Esketamine) (Drug); Placebo (Matched to Mirtazapine) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen Research & Development, LLC Official(s) and/or principal investigator(s): Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
Secondary outcome: Standard Deviation of Speed (SDS) Assessed From an On-road Driving TestMean Speed (MS) Assessed From an On-road Driving Test Mean Lateral Position (MLP) Assessed From an On-road Driving Test Subjective Driving Performance Score Karolinska Sleepiness Scale (KSS) Score Columbia Suicide Severity Rating Scale (C-SSRS) Score Brief Psychiatric Rating Scale (BPRS) Symptom Sub-Scale Score Clinician Administered Dissociative States Scale (CADSS) Score Maximum plasma concentration (Cmax)
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Leiden, Netherlands
Additional Information
Starting date: September 2014
Last updated: December 29, 2014
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