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Renal ImpairmentPhase 1NCT02606084

A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine

A Phase 1 study testing Esketamine in people with Renal Impairment and Healthy, run by Janssen Research & Development, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Renal Impairment, Healthy
What is being tested?
Esketamine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesUnited States
Study dates
4 Dec 2015to 2 Feb 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Study site

    Knoxville, Tennessee

  • Study site

    Miami, Florida

Other trials in United States

About this study

Official title: An Open-Label, Single-Dose, Parallel-Group Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine

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.

Read the detailed description

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.

Being tested
Esketamine
Keywords
Renal Impairment, Healthy, Esketamine
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EsketamineDrug

    Also called JNJ-54135419

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

Study groups in NCT02606084
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants 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.
Receives: Drug: Esketamine
Cohort 2ExperimentalParticipants with moderate renal impairment (CLCR,m >=30 to 49 mL/min) will self-administer esketamine 28 mg intranasally on Day 1.
Receives: Drug: Esketamine
Cohort 3ExperimentalParticipants with severe renal impairment (CLCR,m less than [<] 30 mL/min), not on dialysis will self-administer esketamine 28 mg intranasally on Day 1.
Receives: Drug: Esketamine
Cohort 4ExperimentalParticipants 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.
Receives: Drug: Esketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax)

    The Cmax is the maximum observed concentration.

    Measured: 60 hours post-dose

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    The Tmax is defined as actual sampling time to reach maximum observed concentration.

    Measured: 60 hours post-dose

  3. 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.

    Measured: 60 hours post-dose

  4. 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.

    Measured: 60 hours post-dose

  5. 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.

    Measured: 60 hours post-dose

  6. Amount of Drug excreted in Urine (Ae)

    Total amount excreted into the urine, calculated as the sum of all Ae(t1-t2) intervals.

    Measured: 60 hours post-dose

  7. Measured Creatinine Clearance (CLCR,m)

    Measured: 60 hours post-dose

  8. Estimated Creatinine Clearance (CLCR,e)

    Measured: 60 hours post-dose

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2015 (estimated)
  2. Study start4 Dec 2015
  3. Primary completion2 Feb 2018
  4. Study completion2 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02606084
Sponsor's protocol ID
CR108058
Other IDs
54135419TRD1014
Status last verified
Apr 2025
First submitted
13 Nov 2015
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Esketamine in people with Renal Impairment and Healthy, run by Janssen Research & Development, LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) (time frame: 60 hours post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02606084.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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