NCT01392820已完成1 期
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers
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
- 48
- 试验地点
- 1
- 主要终点
- assess the safety and tolerability during single and multiple ascending oral doses by assessment of AEs, brief neurological examinations, vital signs, eye symptoms question, physical examinations, laboratory parameters, and ECGs, and C-SSRS.
研究概览
简要总结
The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Japanese healthy elderly male and female ≥65 years old.
- •Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg.
- •Be able to understand and comply with the requirements of the study as judged by the investigator(s).
排除标准
- •History of any clinically significant medical or neurologic disease or disorder.
- •History of gastrointestinal surgery or unintentional rapid weight loss.
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.
研究组 & 干预措施
TC-5214
Experimental
干预措施: TC-5214 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
assess the safety and tolerability during single and multiple ascending oral doses by assessment of AEs, brief neurological examinations, vital signs, eye symptoms question, physical examinations, laboratory parameters, and ECGs, and C-SSRS.
时间窗: During the whole study period, ca. 50 days
次要结局
- characterise the PK of TC-5214 in plasma and urine during single and multiple ascending oral doses to Japanese healthy elderly volunteers.(PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part.)
研究者
研究点 (1)
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