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

NCT02228239 | Completed Phase 1

• 3 other identifiers: CR1047642014-002005-38ESKETINTRD1006
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Healthy; Esketamine; Mirtazapine; Psychomotor.

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 validated on-road driving test in a 100 kilometer (km) highway-driving lane.

  4 to 14 hours post-dose

Secondary Outcomes (9)

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

  4 to 14 hours post-dose

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

  4 to 14 hours post-dose

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

  4 to 14 hours post-dose

• Subjective Driving Performance Score

  After completion of driving test (4 to 14 hours post-dose)

• Karolinska Sleepiness Scale (KSS) Score

  Pre-dose, 1, 2 hours and after completion of driving test (4 to 14 hours post-dose)

Study Arms (6)

Sequence 1 (ABC)

EXPERIMENTAL

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; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine)

Sequence 2 (BCA)

EXPERIMENTAL

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; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine)

Sequence 3 (CAB)

EXPERIMENTAL

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; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine)

Sequence 4 (CBA)

EXPERIMENTAL

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; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine)

Sequence 5 (ACB)

EXPERIMENTAL

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; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine)

Sequence 6 (BAC)

EXPERIMENTAL

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; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine)

Interventions

Esketamine 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.

Also known as: JNJ-54135419

Sequence 1 (ABC); Sequence 2 (BCA); Sequence 3 (CAB); Sequence 4 (CBA); Sequence 5 (ACB); Sequence 6 (BAC)

Mirtazapine DRUG

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

Sequence 1 (ABC); Sequence 2 (BCA); Sequence 3 (CAB); Sequence 4 (CBA); Sequence 5 (ACB); Sequence 6 (BAC)

Placebo (Matched to Esketamine) DRUG

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

Sequence 1 (ABC); Sequence 2 (BCA); Sequence 3 (CAB); Sequence 4 (CBA); Sequence 5 (ACB); Sequence 6 (BAC)

Placebo (Matched to Mirtazapine) DRUG

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

Sequence 1 (ABC); Sequence 2 (BCA); Sequence 3 (CAB); Sequence 4 (CBA); Sequence 5 (ACB); Sequence 6 (BAC)

Eligibility Criteria

• Age: 21 Years - 60 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), 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Leiden, Netherlands

Location

MeSH Terms

Interventions

Esketamine; Mirtazapine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: August 28, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12

Locations

NL (1)