NCT01780259

Brief Summary

The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to the medication) of intranasally (through the nose) administered esketamine in healthy participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2012

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

5 months

First QC Date

January 28, 2013

Last Update Submit

August 6, 2013

Conditions

Healthy

Keywords

HealthyEsketaminePharmacokineticsIntranasal

Outcome Measures

Primary Outcomes (3)

  • Maximum plasma concentration during a dosing interval (Cmax) of esketamine

    Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours

  • Time to reach the maximum plasma concentration (tmax) of esketamine

    Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours

  • Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration (AUClast) of esketamine

    Predose, 7 minutes, 12 minutes, 22 minutes, 32 minutes, 40 minutes, 50 minutes, 1 hour, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 9 hours, 12 hours, 18 hours, 24 hours

Secondary Outcomes (1)

  • Number of participants with adverse events

    Up to 78 days

Study Arms (7)

Cohort 1: Treatment A

EXPERIMENTAL

Participants will receive 1 spray of esketamine solution in each nostril once (total dose: 28 mg).

Drug: Esketamine

Cohort 1: Treatment B

EXPERIMENTAL

Participants will receive 1 spray of esketamine solution in each nostril twice, with 5 minutes interval (total dose: 56 mg).

Drug: Esketamine

Cohort 1: Treatment C

EXPERIMENTAL

Participants will receive 1 spray of esketamine solution in each nostril thrice, with 5 minutes interval between each repeated sprays (total dose 84 mg).

Drug: Esketamine

Cohort 1: Treatment D

EXPERIMENTAL

Participants will receive 1 spray of esketamine solution in each nostril thrice, with 10 minutes interval between each repeated sprays (total dose 84 mg).

Drug: Esketamine

Cohort 2: Treatment D

EXPERIMENTAL

Participants will receive 1 spray of esketamine solution in each nostril thrice, with 10 minutes interval between each repeated sprays (total dose 84 mg).

Drug: Esketamine

Cohort 3: Treatment E

EXPERIMENTAL

Participants will receive 1 spray of esketamine solution in each nostril, 4 times with 10 minutes interval between each repeated sprays (total dose: 112 mg). Single dose of oral placebo will be administered 5 minutes before the first intranasal spray of esketamine solution.

Drug: EsketamineDrug: Placebo

Cohort 3: Treatment F

EXPERIMENTAL

Participants will receive 1 spray of placebo solution in each nostril, 4 times with 10 minutes interval between each repeated sprays (total dose: 112 mg). Single 0.25-mg oral dose of triazolam will be administered 5 minutes before the first intranasal spray of placebo solution.

Drug: PlaceboDrug: Triazolam

Interventions

EsketamineDRUG

1 spray of 14 percent of esketamine solution (14 mg of esketamine per 100 microlitre) will be administered intranasally by nasal spray pump in each nostril once (Treatment A-total dose: 28 mg), twice with 5 minutes interval (Treatment B-total dose: 56 mg), thrice with 5 minutes interval between each repeated sprays (Treatment C-total dose: 84 mg), thrice with 10 minutes interval between each repeated sprays (Treatment D-total dose: 84 mg) and 4 times with 10 minutes interval between each repeated sprays (Treatment E-total dose: 112 mg). Treatment A, B, C, D will be administered in Cohort 1; Treatment D will be administered in Cohort 2; and Treatment E will be administered in Cohort 3.

Cohort 1: Treatment ACohort 1: Treatment BCohort 1: Treatment CCohort 1: Treatment DCohort 2: Treatment DCohort 3: Treatment E
PlaceboDRUG

Single dose of oral placebo will be administered 5 minutes before the first intranasal spray of esketamine solution in the Treatment E of Cohort 3. Placebo solution (solution of water for injection with denatonium benzoate) will be administered intranasally solution by nasal spray pump in the Treatment F of Cohort 3.

Cohort 3: Treatment ECohort 3: Treatment F
TriazolamDRUG

Single 0.25-mg oral dose of triazolam will be administered 5 minutes before the first intranasal spray of placebo solution in the Treatment F of Cohort 3.

Cohort 3: Treatment F

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Blood pressure between 90 and 145 mmHg systolic and no higher than 90 mmHg diastolic
  • A 12-lead electrocardiogram consistent with normal cardiac conduction and function
  • Agree to protocol-defined method of contraception
  • Comfortable with self-administration of intranasal medication

You may not qualify if:

  • History of or current clinically significant medical illness including cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; renal or hepatic insufficiency; thyroid disease; neurologic or psychiatric disease, asthma
  • Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center
  • Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or at admission to the study center
  • Known allergy to heparin or history of heparin-induced thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

Related Publications (1)

  • Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.

    PMID: 33128208DERIVED

MeSH Terms

Interventions

EsketamineTriazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic 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
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 31, 2013

Study Start

December 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

BE(1)