An Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Elderly (>= 75 Years of Age) and Healthy Younger Adult Subjects (18 to 55 Years of Age, Inclusive)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last])
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly participants (greater than equal to [>=] 75 years of age) and younger healthy adult participants (18 to 55 years of age, inclusive).
详细描述
This is a single-center, 2-cohort, single-dose, open-label study. The duration of study will be approximately 42 days per participant. The study consists of 3 parts: Screening (that is, 28 days before study commences on Day 1) and open-label Treatment (Day 1) and Follow-up (up to Day 13). Esketamine will be administered by intranasal route (delivery of medications through the nasal mucosa) on Day 1. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Cohort 1, be a man or woman, >= 75 years of age who are either healthy or who present with stable, well-controlled, chronic conditions which frequently occur in the elderly, such as: hyperlipidemia; controlled hypertension; impaired fasting glucose, impaired glucose tolerance or type 2 diabetes mellitus controlled with diet, and/or metformin monotherapy, dipeptidyl peptidase-4 (DPP-4) inhibitor monotherapy or a combination of metformin and DPP-4 inhibitor, who have glycated hemoglobin (HbA1c) levels less than 8 percent; degenerative joint disorders and osteoporosis; kidney function decline appropriate for age. Inclusion of participants with other chronic, well-controlled and stable conditions to Cohort 1 should be reviewed and agreed between the Investigator and the Sponsor
- •For Cohort 2, be a man or woman, 18 to 55 years of age, inclusive
- •For women of childbearing potential in Cohort 2, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening; and a negative urine pregnancy test on Day -1
- •If a man, must agree to use an adequate contraception method as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the study drug
- •Body mass index (BMI) (weight [kg]/height^2 [m]^2) between 18 and 32 kg/m^2 (inclusive), and body weight not less than 50 kg
排除标准
- •Diagnosed with a current or previous psychiatric disorder including but not limited to psychotic, bipolar, major depressive, or anxiety disorder
- •Clinically significant medical illness
- •Severe renal impairment
- •Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center (Day -1) as deemed appropriate by the investigator
- •History of drug or alcohol abuse disorder within the past 1 year, or a reason to believe a participant has such a history
研究组 & 干预措施
Cohort 1
Elder participants will receive esketamine hydrochloride solution (containing 14 milligram (mg) of esketamine base per 100 microliter [mcl] of intranasal spray) by intranasal route using nasal spray pump at 0, 5 and 10 minutes on Day 1.
干预措施: Esketamine (Drug)
Cohort 2
Younger adults will receive esketamine hydrochloride solution (containing 14 milligram (mg) of esketamine base per 100 microliter [mcl] of intranasal spray) by intranasal route using nasal spray pump at 0, 5 and 10 minutes on Day 1.
干预措施: Esketamine (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last])
时间窗: up to 24 hours after study drug administration
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Elimination half-life period (t1/2) associated with the terminal slope (Lambda z)
时间窗: up to 24 hours after study drug administration
Elimination half-life associated with the terminal slope (lambda\[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Maximum Plasma Concentration (Cmax)
时间窗: up to 24 hours after study drug administration
The Cmax is the maximum plasma concentration.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 42 days
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time to reach maximum concentration (tmax)
时间窗: up to 24 hours after study drug administration
The Tmax is time to reach the maximum plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to 12 Hours (AUC [0-12])
时间窗: up to 24 hours after study drug administration
The AUC (0-12) is the area under the plasma concentration-time curve from time 0 to 12 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
时间窗: up to 24 hours after study drug administration
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
次要结局
未报告次要终点