NCT00690079已完成1 期
A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Caucasian Young and Elderly Subjects After Oral Multiple Doses.
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
- 69
- 试验地点
- 1
- 主要终点
- Safety AEs and vital signs
研究概览
简要总结
The study is being performed in order to learn more about the safety and tolerability of AZD1386. AZD1386 is primary intended for treatment of chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Caucasians, males or females aged ≥20 and ≤ 45 years or between 65 80 years. Female subjects must be surgically sterile or post-menopausal for at least 12 months prior to the enrolment visit.
- •Body Mass Index (BMI) of ≥18 to ≤ 30 kg/m2 and weight of ≥50 to ≤100 kg
- •Clinically normal physical findings including heart rate > 45 bpm and laboratory values and normal resting ECG
排除标准
- •History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study.
- •History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity.
- •Subjects with a high decrease in blood pressure within 5 minutes when going from a supine to standing position.
研究组 & 干预措施
AZD1386
Experimental
7 groups receiving a specified volume of the active component AZD1386 at different points of time.
干预措施: AZD1386 (Drug)
Placebo
Placebo Comparator
7 groups receiving a specified volume of placebo at different points of time
干预措施: Placebo (Drug)
结局指标
主要结局
Safety AEs and vital signs
时间窗: During the whole study
ECG-recordings
时间窗: ECGs (5 minutes) Days 1 and 12. 2 ECGs (5 minutes) Days 3, 6 and 10. 1 ECG (5 minutes) Days 2 and 13.
次要结局
- PK(Days 1, 5 and 12, 12 times each day. Days 4, 6, 8, 10 and 14, once. Days 2, 3, 7, 9, 11 and 13 twice.)
研究者
研究点 (1)
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