Two-Part, Sequential Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TC-5619-238 in Elderly Subjects With and Without Alzheimer's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 10
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
This is a Phase 1 study to examine the safety, tolerability and pharmacokinetics of TC-5619 in elderly subjects with and without Alzheimer's disease. Group 1 includes elderly subjects with Alzheimer's disease to receive TC-5619 or placebo for 28 days to evaluate safety and tolerability. Group 2 includes healthy elderly subjects in a dose escalation design to receive TC-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Subjects will receive a placebo capsule orally once a day for 28 days (Group 1) or 10 days (Group 2).
干预措施: Placebo (Drug)
TC-5619
Subjects will receive a TC-5619 orally once a day for 28 days (Group 1) or 10 days (Group 2).
干预措施: TC-5619 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: Group 1: screening, Days -14, Day -1, Days 1, 2, 3, 27-33; Group 2: Day -14, Day -1, Days 1 -14
Number of participants with treatment-emergent adverse events
次要结局
- Pharmacokinetic profiles(Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14)
- Markers of inflammation in cerebrospinal fluid(Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14)
- Markers of inflammation in plasma(Group 1: Days 1, 2, 28-32; Group 2: Day 1, 2, 4, 8, 10-14)