CompletedPhase 1ketamine

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

Sponsored by Janssen Research & Development, LLC

NCT ID
NCT02606084
Target Enrollment
32 participants
Start Date
2015-12-04
Est. Completion
2018-02-02

About This Study

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.

Conditions Studied

Renal ImpairmentHealthy

Interventions

  • Esketamine

Eligibility

Age:18 Years - 70 Years
Healthy Volunteers:Yes
View full eligibility 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)

Study Locations (2)

Miami, Florida, United States
Knoxville, Tennessee, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source