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

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ClinicalTrials.gov Identifier: NCT02606084
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Renal Impairment Healthy Drug: Esketamine Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: Cohort 1
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
Participants will self-administer esketamine solution intranasally 28 milligram (mg) on Day 1.
Other Name: JNJ-54135419
Experimental: Cohort 2
Participants with moderate renal impairment (CLCR,m >=30 to 49 mL/min) will self-administer esketamine 28 mg intranasally on Day 1.
Drug: Esketamine
Participants will self-administer esketamine solution intranasally 28 milligram (mg) on Day 1.
Other Name: JNJ-54135419
Experimental: Cohort 3
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
Participants will self-administer esketamine solution intranasally 28 milligram (mg) on Day 1.
Other Name: JNJ-54135419
Experimental: Cohort 4
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
Participants will self-administer esketamine solution intranasally 28 milligram (mg) on Day 1.
Other Name: JNJ-54135419


Outcome Measures

Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 60 hours post‐dose ]
    The Cmax is the maximum observed concentration.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 60 hours post‐dose ]
    The Tmax is defined as actual sampling time to reach maximum observed concentration.

  3. Area Under the Plasma Concentration‐Time Curve From Time Zero to Last Quantifiable Time (AUC [0‐last]) [ Time Frame: 60 hours post‐dose ]
    The AUC (0‐last) is the area under the plasma concentration‐time curve from time zero to last quantifiable time.

  4. Area Under the Plasma Concentration‐Time Curve From Time Zero to Infinite Time (AUC[0‐infinity]) [ Time Frame: 60 hours post‐dose ]
    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.

  5. Elimination Rate Constant (Lambda[z]) [ Time Frame: 60 hours post‐dose ]
    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.

  6. Amount of Drug excreted in Urine (Ae) [ Time Frame: 60 hours post‐dose ]
    Total amount excreted into the urine, calculated as the sum of all Ae(t1-t2) intervals.

  7. Measured Creatinine Clearance (CLCR,m) [ Time Frame: 60 hours post‐dose ]
  8. Estimated Creatinine Clearance (CLCR,e) [ Time Frame: 60 hours post‐dose ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: Screening up to End of Follow-up Phase (approximately up to 34 - 38 days) ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606084


Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, Florida
Advanced Pharma CR, LLC Recruiting
Miami, Florida, United States, 33147
United States, Tennessee
New Orleans Center for Clinical Research Recruiting
Knoxville, Tennessee, United States, 37923
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02606084     History of Changes
Other Study ID Numbers: CR108058
54135419TRD1014 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Renal Impairment
Healthy
Esketamine

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases