Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult Participants

NCT02345148 | Completed Phase 1

• 3 other identifiers: CR106172ESKETINTRD10122014-003690-42
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly participants (greater than equal to \[\>=\] 75 years of age) and younger healthy adult participants (18 to 55 years of age, inclusive).

Conditions

Healthy

Keywords

Healthy; Esketamine; JNJ-54135419

Outcome Measures

Primary Outcomes (7)

• Maximum Plasma Concentration (Cmax)

  The Cmax is the maximum plasma concentration.

  up to 24 hours after study drug administration

• Time to reach maximum concentration (tmax)

  The Tmax is time to reach the maximum plasma concentration.

  up to 24 hours after study drug administration

• Area Under the Plasma Concentration-Time Curve From Time Zero to 12 Hours (AUC [0-12])

  The AUC (0-12) is the area under the plasma concentration-time curve from time 0 to 12 hours post-dose.

  up to 24 hours after study drug administration

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last])

  The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.

  up to 24 hours after study drug administration

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])

  The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.

  up to 24 hours after study drug administration

• Elimination half-life period (t1/2) associated with the terminal slope (Lambda z)

  Elimination half-life associated with the terminal slope (lambda\[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).

  up to 24 hours after study drug administration

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  42 days

Study Arms (2)

Cohort 1

EXPERIMENTAL

Elder participants will receive esketamine hydrochloride solution (containing 14 milligram (mg) of esketamine base per 100 microliter \[mcl\] of intranasal spray) by intranasal route using nasal spray pump at 0, 5 and 10 minutes on Day 1.

Drug: Esketamine

Cohort 2

EXPERIMENTAL

Younger adults will receive esketamine hydrochloride solution (containing 14 milligram (mg) of esketamine base per 100 microliter \[mcl\] of intranasal spray) by intranasal route using nasal spray pump at 0, 5 and 10 minutes on Day 1.

Drug: Esketamine

Interventions

Esketamine DRUG

Esketamine 84 mg will be self-administered by participants as intranasal spray at 0, 5 and 10 minutes on Day 1.

Also known as: Esketamine hydrochloride, JNJ-54135419

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Cohort 2, be a man or woman, 18 to 55 years of age, inclusive
• For women of childbearing potential in Cohort 2, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1
• If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the study drug
• Body mass index (BMI) (weight \[kg\]/height\^2 \[m\]\^2) between 18 and 32 kg/m\^2 (inclusive), and body weight not less than 50 kg

You may not qualify if:

• Diagnosed with a current or previous psychiatric disorder including but not limited to psychotic, bipolar, major depressive, or anxiety disorder
• Clinically significant medical illness
• Severe renal impairment
• Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center (Day -1) as deemed appropriate by the investigator
• History of drug or alcohol abuse disorder within the past 1 year, or a reason to believe a participant has such a history

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

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: 33128208 DERIVED

MeSH Terms

Interventions

Esketamine

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: December 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

BE (1)