An Open-label, Single-Dose Study to Assess the Pharmacokinetics, Safety and Tolerability of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Subjects

Janssen Research & Development, LLC0 个研究点目标入组 29 人开始时间: 2013年11月最近更新: 2014年1月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Janssen Research & Development, LLC
入组人数: 29
主要终点: Maximum plasma concentration during a dosing interval (Cmax) of esketamine and noresketamine

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this Phase 1 study is to characterize the pharmacokinetic profile (what the body does to the medication) of esketamine when given by the intranasal route (through the nose) to healthy adult Japanese and Caucasian participants.

详细描述

This is an open-label single-center study with 2 cohorts (groups). The study will consist of a screening phase, a treatment phase, and a follow-up visit (9 to 13 days after the last dose of the study drug). During the screening phase, participants will be evaluated to determine if they meet the study eligibility criteria. A target of 14 healthy Japanese and 14 healthy Caucasian adult participants (20 to 55 years of age inclusive) will be enrolled in Cohort 1 and Cohort 2, respectively.

The participants in each cohort will self-administer each of the 3 different single-dose regimens of intranasal esketamine (Treatments A, B, and C) over the 3 treatment periods (ie, 1 treatment per period) in an open-label manner (both the investigator and the participant knows which intervention the participant receives). The participants will be randomly (like the toss of a coin) assigned to receive Treatment A and Treatment B in the first two periods (ie, Treatment A in Period 1 and Treatment B in Period 2, or the reverse order). All participants will receive Treatment C in Period 3. The regimens differ in the number of sprays to achieve the total dose and the total esketamine dose administered.

Safety and tolerability will be evaluated throughout the study and will include assessment of adverse events, targeted nasal examinations, laboratory tests, electrocardiogram, physical examination, pulse oximetery, and vital signs.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy Japanese (Cohort 1) or Caucasian (Cohort 2) man or woman, between 20 to 55 years of age
•Resided outside of Japan for no more than 5 years and have parents and maternal and paternal grandparents who are of Japanese ethnicity
•Blood pressure (after the participant is in the supine position for 5 minutes) between 90 and 145 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
•A 12-lead electrocardiogram consistent with normal cardiac conduction and function
•Smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration
•Comfortable with self-administration of intranasal medication and able to follow instructions provided
•Exclusion criteria:
•History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); hypertension or vascular disorders; significant pulmonary disease, including any bronchospastic respiratory disease; diabetes mellitus; renal or hepatic insufficiency; thyroid disease; neurologic or psychiatric disease, infection; kidney/urinary tract disturbances; sleep apnea, or myasthenia gravis, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
•Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center
•Anatomical or medical conditions that may impede delivery or absorption of study medication
•Has an abnormal or deviated nasal septum with any 1 or more of the following symptoms: blockage of 1 or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, frequent sinus infections, noisy breathing during sleep, and at times has facial pain, headaches, and postnasal drip
•Has a current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders; mood disorder with postpartum onset, somatoform disorders, fibromyalgia, or chronic fatigue syndrome; generalized anxiety disorder, panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa

排除标准

未提供

研究组 & 干预措施

Cohort 1: Treatment A

Experimental

Japanese participants will receive 1 spray of esketamine solution in each nostril (total dose: 28 mg).

干预措施: Esketamine (Drug)

Cohort 1: Treatment B

Experimental

Japanese participants will receive 1 spray of esketamine solution in each nostril at time 0 and 5 minutes (total dose: 56 mg).

干预措施: Esketamine (Drug)

Cohort 1: Treatment C

Experimental

Japanese participants will receive 1 spray of esketamine solution in each nostril at time 0, 5, and 10 minutes (total dose: 84 mg).

干预措施: Esketamine (Drug)

Cohort 2: Treatment A

Experimental

Caucasian participants will receive 1 spray of esketamine solution in each nostril (total dose: 28 mg).

干预措施: Esketamine (Drug)

Cohort 2: Treatment B

Experimental

Caucasian participants will receive 1 spray of esketamine solution in each nostril at time 0 and 5 minutes (total dose: 56 mg).

干预措施: Esketamine (Drug)

Cohort 2: Treatment C

Experimental

Caucasian participants will receive 1 spray of esketamine solution in each nostril at time 0, 5 and 10 minutes (total dose: 84 mg).

干预措施: Esketamine (Drug)