A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
Status: | Completed |
---|---|
Conditions: | Healthy Studies, Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology, Other |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 3/31/2019 |
Start Date: | December 4, 2015 |
End Date: | February 2, 2018 |
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
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.
intranasally administered esketamine in participants with impaired renal function when
compared to participants with normal renal function.
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.
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.
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)
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