Overview

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

Status:
Completed
Trial end date:
2018-02-02
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Esketamine
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)