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).
This is a single-center, 2-cohort, single-dose, open-label study. The duration of study will be approximately 42 days per participant. The study consists of 3 parts: Screening (that is, 28 days before study commences on Day 1) and open-label Treatment (Day 1) and Follow-up (up to Day 13). Esketamine will be administered by intranasal route (delivery of medications through the nasal mucosa) on Day 1. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Esketamine 84 mg will be self-administered by participants as intranasal spray at 0, 5 and 10 minutes on Day 1.
Unnamed facility
Merksem, Belgium
Maximum Plasma Concentration (Cmax)
The Cmax is the maximum plasma concentration.
Time frame: up to 24 hours after study drug administration
Time to reach maximum concentration (tmax)
The Tmax is time to reach the maximum plasma concentration.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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Time frame: 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.
Time frame: 42 days