NCT02606084

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2015

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

December 4, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

November 13, 2015

Last Update Submit

April 25, 2025

Conditions

Renal ImpairmentHealthy

Keywords

Renal ImpairmentHealthyEsketamine

Outcome Measures

Primary Outcomes (8)

  • Maximum Observed Plasma Concentration (Cmax)

    The Cmax is the maximum observed concentration.

    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.

    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.

    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.

    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.

    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.

    60 hours post-dose

  • Measured Creatinine Clearance (CLCR,m)

    60 hours post-dose

  • Estimated Creatinine Clearance (CLCR,e)

    60 hours post-dose

Secondary Outcomes (1)

  • Number of Participants with Adverse Events

    Screening up to End of Follow-up Phase (approximately up to 34 - 38 days)

Study Arms (4)

Cohort 1

EXPERIMENTAL

Participants with mild renal impairment (Measured Creatinine Clearance \[CLCR,m\] greater than or equal to \>= 50 to 79 milliliter/minute \[mL/min\]) will self-administer esketamine 28 milligram (mg) intranasally on Day 1.

Drug: Esketamine

Cohort 2

EXPERIMENTAL

Participants with moderate renal impairment (CLCR,m \>=30 to 49 mL/min) will self-administer esketamine 28 mg intranasally on Day 1.

Drug: Esketamine

Cohort 3

EXPERIMENTAL

Participants with severe renal impairment (CLCR,m less than \[\<\] 30 mL/min), not on dialysis will self-administer esketamine 28 mg intranasally on Day 1.

Drug: Esketamine

Cohort 4

EXPERIMENTAL

Participants with normal renal function and no evidence of kidney damage (CLCR,m \>= 80 mL/min) will self-administer esketamine 28 mg intranasally on Day 1.

Drug: Esketamine

Interventions

EsketamineDRUG

Participants will self-administer esketamine solution intranasally 28 milligram (mg) on Day 1.

Also known as: JNJ-54135419
Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
  • For women of childbearing potential, must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at Screening; and a negative urine pregnancy test on Day minus (-) 1
  • Comfortable with self-administration of intranasal medication and able to follow instructions provided
  • Hemoglobin concentration of greater than or equal to (\>=) 10 grams per deciLiter (g/dL) (Only for cohorts 1, 2, and 3)
  • Platelet count of \>= 50,000 counts/microliter (Only for cohorts 1, 2, and 3)

You may not qualify if:

  • Current or previous diagnosis of psychotic or major depressive disorder (MDD) with psychosis, bipolar or related disorder, intellectual disability, borderline personality disorder, or antisocial personality disorder
  • A lifetime history of cerebrovascular disease including stroke or transient ischemic attack, aneurysmal vascular disease
  • Unstable coronary artery disease or myocardial infarction in the last 12 months or any unstable angina requiring revascularization procedure, hemodynamically significant valvular heart disease, or New York Heart Association Class III-IV heart failure
  • Has had a renal transplant or diagnosis of systemic lupus erythromatosus or renal carcinoma
  • Has a nasal piercing
  • Participant requires dialysis (Only for cohorts 1, 2, and 3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 17, 2015

Study Start

December 4, 2015

Primary Completion

February 2, 2018

Study Completion

February 2, 2018

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations

US(2)