JPRN-UMIN000010218已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetic Study of TAK-070 in Healthy Elderly Subjects - A Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetic Study of TAK-070 in Healthy Elderly Subjects
The University of Tokyo Hospital Unit for Early and Exploratory Clinical Development0 个研究点目标入组 96 人开始时间: 2013年3月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 65years-old 至 80years-old（—）
- 性别
- Male
入选标准
- 未提供
排除标准
- •The following subjects will be excluded from the study: a)a hypersensitivity to TAK-070 or related compounds. b)was administered TAK-070 in past times or participated in any other clinical trial within 3 months. c)a history or complication of significant neurological, cerebrovascular, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease (according to investigator's decision). d)a history or complication of schizophrenia defined by DSM-IV criteria. e)a history of delirium, paranoia, bipolar disorder or depression within the past 5 years f)any clinically important abnormal finding in physical examination, ECGs or clinical laboratory tests. g)a clinically significant illness within 30 days before in hospital (Day -3). h)took disallowed medications within 14 days before the study drug administration or continues to take them during the study. i)took OTC medication, including St. John's Wort, gingko biloba, or nutraceuticals, within 7 days of study drug administration or continues to take during the study. j)has consumed tobacco, nicotine or alcohol within 30 days before study drug administration and is not capable of complying with no smoking and no drinking during the study. k)a history of alcohol abuse defined by DSM-IV criteria within a year of screening or is an addicted drinker. l)positive urine tests for selected substances of abuse, including alcohol, at screening. m)clinical findings of active hepatic disease or ALT/AST exceeds 1.5 times of upper limits of normal level. n)made a blood donation or loses blood more than 200mL within 30 days before the screening. o)makes a blood donation during the duration of the study or within 4 weeks after the study. p)would not be willing to comply with the protocol, be hospitalized at the trial site during the study or cooperate with principal investigator, sub-investigator or clinical cooperator, or is judged not to carry the trial through by principal investigator or sub-investigator.
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