A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects

Sumitomo Pharma (Suzhou) Co., Ltd.1 个研究点分布在 1 个国家目标入组 37 人开始时间: 2014年3月最近更新: 2019年1月11日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 37
试验地点: 1
主要终点: Lurasidone Cmax

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研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral administration of different doses in healthy Chinese subjects.

To evaluate the safety and tolerability of lurasidone after single oral administration of different doses in healthy Chinese subjects.

详细描述

Single administration, double-blinded, placebo-controlled (3 subjects in each group will take placebo) and 3 dose groups (20 mg, 40 mg and 80 mg). There are three groups which are 20mg lurasidone or placebo, 40mg lurasidone or placebo and 80mg lurasidone or placebo.

This study comprises a screening period (between signing of the informed consent form and Day -2), baseline period (Day -1), treatment period (Days 1-3) and ending of study examination period (Days 8-11 after the last sample collection for PK evaluation).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 18 Years 至 40 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•After detailed explanations of study objectives, methods and procedures, anticipated efficacy, pharmacologic actions, risks and other relevant contents, subjects are aware of all relevant information related to this study and have signed the written informed consent form voluntarily.
•Male subjects are 18≤ age <40 years of age when signing the informed consent.
•Subjects with body weight of 50.0≤ and ≤ 80.0 kg and BMI (body mass index) of 19.0≤ and <24.0 at screening examination.
•Subjects are able to comply with all requirements during this study period, receive various physical and laboratory examinations per study protocol, and report subjective symptoms.

排除标准

•Based on the examination results during screening period, various physical and laboratory examinations performed 1 day before medication (Day-1 ) and before administration of study drug on the medication day, there are certain medical concerns on subject's health status in principal investigator's or study supervising physician's opinions (certain treatment or medical observation are deemed necessary).
•Subjects with past diabetic history.
•Subjects has an HbA1c level of >6.2% at screening.
•Subjects with history of gastrointestinal operations.
•Because of subjects' past medical history of cardiovascular diseases, liver diseases, renal diseases, endocrine disorders, digestive diseases, hematologic diseases, respiratory diseases, mental illness, neurological disorders (especially epilepsy and other convulsive disorders) and other diseases, subjects are unsuitable to participate in this study in the principal investigator's or study supervising physician's opinions.
•Subjects with past history of allergy to drugs.
•Subjects have consumed grapefruit or food containing grapefruit ingredients between 7 days before medication (Day -7) and administration of study drug on the medication day (Day 1). Subjects have consumed food containing hypericum perforatum L. ingredients between 14 days before medication (Day-14) and administration of study drug on the medication day (Day 1).
•Subjects have taken any drugs (including over-the-counter drugs) between 7 days before medication (Day_-7) and administration of study drug on medication day.
•Regular drinker (criteria are mean daily consumption ≥2 bottles of 640 mL beers or Chinese liquor≥150 mL).
•Subjects are used to drink large amount (criteria are daily consumption>1.8 L) of caffeine-containing beverages (e.g. coffee, black tea, green tea, coca cola or nutritional oral solution, etc).
•Subjects have history of drug abuse or positive urine drug tests.
•Subjects with positive immunologic test results.
•Average amount of daily smoking>20 cigarettes.
•Subjects have taken other study drugs within 3 months (Day_-90~Day 1) before medication.
•Subjects received lurasidone orally before.
•Subjects have history of blood donations of 400 mL within 3 months (Day_-90~Day 1) before medication; 200 mL within 1 month (Day_-30~Day 1) before medication; or donation of blood components within 2 weeks (Day_-14~Day 1) before medication.
•Subjects have consumed alcohol-containing food between 3 days before medication 3 (Day_-3) and before administration of study drug on medication day.
•Subjects can not tolerate venipuncture or have poor peripheral venous access.
•Subjects are unwilling to abstain from vigorous exercise from Day_-1 until discharge.
•Other subjects who are unsuitable to participate in this study in principal investigator's or study supervising physician's opinions.

研究组 & 干预措施

20mg lurasidone

Experimental

single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.

干预措施: 20mg lurasidone (Drug)

20mg lurasidone

Experimental

single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.

干预措施: placebo (Drug)

40mg lurasidone

Experimental

single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.

干预措施: 40mg lurasidone (Drug)

40mg lurasidone

Experimental

single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.

干预措施: placebo (Drug)

80mg lurasidone

Experimental

single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.

干预措施: 80mg lurasidone (Drug)

80mg lurasidone

Experimental

single oral lurasidone in 30 minutes after beginning of the over 350 kcal breakfast on day 1.The subjects will be follow up on day 8 to 11.

干预措施: placebo (Drug)