The purpose of this study is to evaluate the pharmacokinetics of a single dose of intranasally administered esketamine in participants with impaired renal function when compared to participants with normal renal function.
This is an open-label (all people know the identity of the intervention), single-dose, single-center, parallel group study to characterize the pharmacokinetics and safety of a single 28 milligram (mg) dose of esketamine in both participants with varying stages of renal impairment and healthy participants. A total of approximately 32 medically stable men and women with varying degrees of renal function impairment or no renal impairment will be enrolled. The study consists of a Screening period of up to Days -21 to -2, open label phase of Days -1 to 4, and end-of-study (11 plus \[+\] or minus \[-\] 2 days after final dose). The participants will be assigned to 1 of 4 groups (8 participants per group) based on creatinine clearance (CLCR,m). Safety and tolerability will be assessed from the time of consent until the end of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Participants will self-administer esketamine solution intranasally 28 milligram (mg) on Day 1.
Unnamed facility
Miami, Florida, United States
Unnamed facility
Knoxville, Tennessee, United States
Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed concentration.
Time frame: 60 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed concentration.
Time frame: 60 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Time frame: 60 hours post-dose
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, C (last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Time frame: 60 hours post-dose
Elimination Rate Constant (Lambda[z])
Lambda (z) is first-order elimination 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: 60 hours post-dose
Amount of Drug excreted in Urine (Ae)
Total amount excreted into the urine, calculated as the sum of all Ae(t1-t2) intervals.
Time frame: 60 hours post-dose
Measured Creatinine Clearance (CLCR,m)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 60 hours post-dose
Estimated Creatinine Clearance (CLCR,e)
Time frame: 60 hours post-dose
Number of Participants with Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Screening up to End of Follow-up Phase (approximately up to 34 - 38 days)