The purpose of this study is to evaluate the pharmacokinetics of intranasally administered esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to evaluate the effects of rifampin on the pharmacokinetics of intranasally administered esketamine in healthy Caucasian participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
100-mcL spray of 14% esketamine solution (14 mg) for a total dose of 56 mg.
2 capsules (300 mg each) of rifampin.
Unnamed facility
Cypress, California, United States
Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration.
Time frame: Up to Day 2
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Time frame: Up to Day 2
Time to Last Observed Quantifiable Plasma Concentration (Tlast)
The Tlast is the time to last observed quantifiable plasma concentration.
Time frame: Up to Day 2
Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours (AUC12h)
The (AUC12h) is the area under the plasma concentration-time curve from time 0 to 12 hours Post-dose.
Time frame: Up to Day 2
Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last)
The AUC (0-last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
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(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentrations; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Time frame: Up to Day 2
Elimination Half-life (t1/2)
Elimination half-life (t \[1/2\]) is associated with the terminal slope (lambda \[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Time frame: Up to Day 2
Rate Constant (Lambda[z])
Lambda(z) is 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.
Time frame: Up to Day 2
Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: Up to Follow-up (45 days)
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