A Phase 1 interventional study of Esketamine in Hepatic Impairment and Normal Hepatic Function, sponsored by Janssen Research & Development, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in both participants with varying stages of hepatic impairment and healthy participants.
This is a parallel group, single-center, single-dose, open-label (all people know the identity of the intervention), study to assess the pharmacokinetics and safety of a single 28 milligram (mg) dose of esketamine in both participants with varying stages of hepatic impairment and healthy participants. The participants will be assigned to 1 of 3 groups (8 participants per group) based on hepatic impairment which will be classified during Screening. Cohort 1 (participants with moderate hepatic impairment), Cohort 2 (participants with mild hepatic impairment), and Cohort 3 (participants with normal hepatic function and no evidence of liver damage). Participants will self-administer a single dose of intranasal Esketamine 28 mg. The total duration of the study from Screening through Follow-up, is approximately 34 to 38 days. Blood and urine samples for assessment of Esketamine pharmacokinetics will be collected for up to 60 hours after study drug administration. Participants' safety will be monitored throughout the study.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
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Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Cohorts 1, 2 and 3 (All participants):
Cohorts 1 and 2 (Participants with Hepatic impairment):
Exclusion Criteria:
Cohorts 1, 2 and 3 (All participants):
Cohorts 1 and 2 (Participants with Hepatic impairment):
Cohorts 3 (Healthy participants):
Participants with moderate hepatic impairment will receive esketamine solution (containing 14 milligram \[mg\] of esketamine base per 100 microliter \[mcl\]) by intranasal route into each nostril using nasal spray pump at 0 hour (h) on Day 1.
Drug: Esketamine
Participants with mild hepatic impairment will receive esketamine solution (containing 14 mg of esketamine base per 100 mcl) by intranasal route into each nostril using nasal spray pump at 0h on Day 1.
Drug: Esketamine
Participants with normal hepatic function and no evidence of liver damage will receive esketamine solution (containing 14 mg of esketamine base per 100 mcl) by intranasal route into each nostril using nasal spray pump at 0h on Day 1.
Drug: Esketamine
Esketamine 28 mg will be self-administered by participants as intranasal spray at 0 hour (h) on Day 1.
Also known as: JNJ-54135419
Maximum Plasma Concentration (Cmax)
The Cmax is the maximum plasma concentration.
Time frame: up to 60 hours after study drug administration
Time to Reach Maximum Concentration (tmax)
Time to reach the maximum observed plasma concentration.
Time frame: up to 60 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 60 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 60 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).
Time frame: up to 60 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 12 hours after study drug administration
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 60 hours after study drug administration
Cmax Metabolite to Parent Ratio (MPR Cmax)
Cmax metabolite to parent ratio, and corrected for molecular weight if necessary.
Time frame: up to 60 hours after study drug administration
AUC(last) Metabolite to Parent Ratio (MPR AUC[last])
AUC(last) metabolite to parent ratio, and corrected for molecular weight if necessary.
Time frame: up to 60 hours after study drug administration
AUC (infinity) Metabolite to Parent Ratio (MPR AUC [infinity])
AUC (infinity) metabolite to parent ratio, and corrected for molecular weight if necessary.
Time frame: up to 60 hours after study drug administration
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: up to 60 hours after study drug administration
Percentage of Drug dose Excreted into Urine
Total amount excreted into the urine, expressed as a percentage of the administered dose, calculated as (Ae/dose)\*100, and corrected for molecular weight if necessary.
Time frame: up to 60 hours after study drug administration
Renal Clearance
Renal clearance calculated as Ae/AUC (infinity).
Time frame: up to 60 hours after study drug administration
Ae Metabolite to Parent Ratio (MPR Ae)
Ae metabolite to parent ratio, and corrected for molecular weight if necessary.
Time frame: up to 60 hours after study drug administration
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE 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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline up to Day 11
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC