Clinical trial NCT02606084: A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Healthy
Keywords: Renal Impairment
Healthy
Esketamine
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-11-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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)

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 60 hours post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 60 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
timeFrame: 60 hours post-dose
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
timeFrame: 60 hours post-dose
measure: Elimination Rate Constant (Lambda[z])
timeFrame: 60 hours post-dose
measure: Amount of Drug excreted in Urine (Ae)
timeFrame: 60 hours post-dose
measure: Measured Creatinine Clearance (CLCR,m)
timeFrame: 60 hours post-dose
measure: Estimated Creatinine Clearance (CLCR,e)
timeFrame: 60 hours post-dose
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Screening up to End of Follow-up Phase (approximately up to 34 - 38 days)
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Knoxville
country: United States
state: Tennessee
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: