NCT01294540已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Doses of E2609 in Healthy Subjects and an Elderly Cohort
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
- Eisai Inc.
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Safety and tolerability as evidenced by the number of subjects with adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.
详细描述
The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in healthy elderly volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 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 Comparator: 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability as evidenced by the number of subjects with adverse events
时间窗: 38 days
次要结局
- To assess the pharmacokinetics (PK) of E2609 in plasma and urine following administration of single oral doses(4 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male ParticipantsJapanese Healthy Adult Male ParticipantsNCT03237156Takeda24
招募中
1 期
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RS-C1001 Tablets in Chinese Healthy SubjectsDyslipidemiaNCT0666942972
已完成
1 期
IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction StudyHealthy VolunteersNCT01549106SecuraBio106
已完成
1 期
BN201 SAD MAD Study in Healthy SubjectsOptic NeuritisNeuritis, With Demyelination OpticNCT03630497Accure Therapeutics48
已完成
1 期
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male ParticipantsHealthy VolunteersNCT01964872Janssen Cilag N.V./S.A.84