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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Impairment

Treatments: Drug: Esketamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02606084

54135419TRD1014 (Other Identifier)

CR108058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Esketamine

Cohort 2

Experimental group

Description:

Participants with moderate renal impairment (CLCR,m \>=30 to 49 mL/min) will self-administer esketamine 28 mg intranasally on Day 1.

Treatment:

Drug: Esketamine

Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: Esketamine

Cohort 4

Experimental group

Description:

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.

Treatment:

Drug: Esketamine