NCT01239771已完成1 期
A Phase I, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of TC-5214 Given as Multiple Ascending Oral Doses in Medically Stable Elderly Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of Adverse events
研究概览
简要总结
The purpose of the study is to assess safety, tolerability and pharmacokinetics of TC-5214 in medically stable elderly subjects following multiple oral doses.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically stable male and female subjects aged greater than or equal to 65 years with suitable veins for cannulation or repeated venipuncture. Subjects may have controlled chronic diseases such as hypertension, type 2 diabetes, osteoarthritis, stable chronic obstructive pulmonary disease, mild or moderate renal insufficiency (Estimated glomerular filtration rate (eGFR) per the Modified Diet in Renal Disease [MDRD] formula >50 mL/min/1.73 m2), rhinitis etc. as long as there has not been any significant changes in their medical condition or medications for the preceding 6 weeks. Classification of renal impairment will be based using an MDRD equation
- •Male subjects who are sexually active must use a condom and their partner if of childbearing potential must use a reliable method of contraception from the first dose of investigational product until 3 months after their last dose
- •Have a body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg
排除标准
- •History of any clinically significant medical, neurologic or psychiatric disease or disorder (other than those previously defined as acceptable for this population, see inclusion criterion 1) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study: This includes seizure activity and repeated episodes of major depression
- •Significant cardiovascular or cerebrovascular disease such as: a history of acute coronary syndrome; angina that has been symptomatic in the last 6 months; significant symptomatic arrhythmia; a stroke; transient ischemic attack that have occurred in the last 6 months
- •History or presence of gastrointestinal or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Subjects who have type 2 diabetes must have an HbA1c of less than 8% according to the National Glycohemoglobin Standardization Program (NGSP) at screening
- •Significant renal insufficiency as defined by eGFR per the MDRD formula <50 mL/min/1.73 m2 (individual eGFR measurements will be documented in the protocol).
研究组 & 干预措施
1
Experimental
TC-5214
干预措施: TC-5214 (Drug)
2
Placebo Comparator
Placebo matched to TC-5214
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Adverse events
时间窗: Range of 5 days
Neurological examinations
时间窗: Range of 5 days
Visual acuity tests
时间窗: Range of 5 days
Vital signs
时间窗: Range of 5 days
Physical examinations
时间窗: Range of 5 days
Laboratory parameters
时间窗: Range of 5 days
Suicidality as assessed by the Columbia-Suicide Severity Rating Scale
时间窗: Range of 5 days
Electrocardiograms
时间窗: Range of 5 days
次要结局
- Pharmacokinetic variables of TC-5214 by assessment of drug concentrations in plasma(Range of 5 days)
研究者
研究点 (1)
Loading locations...
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