The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly Japanese subjects and healthy younger adult Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Subjects will self-administer intranasal esketamine as per the treatment regimen.
Unnamed facility
Cypress, California, United States
Maximum Plasma Concentration (Cmax)
The Cmax is the maximum plasma concentration.
Time frame: up to Day 2
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 zero to 12 hours, 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 Day 2
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (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 Day 2
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 Day 2
Terminal Half-Life(t[1/2])
Terminal half-life (t\[(1/2\]) is defined as 0.693/Lambda(z).
Time frame: up to Day 2
Lambda(z)
Lambda(z) is the first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
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Time frame: up to Day 2
Number of subjects with Adverse Events (AEs) as a measure of safety and tolerability
Time frame: Screening up to Follow-up (63 days)