NCT00860353终止1 期
A Double Blind, Randomised, Placebo-controlled, Phase I Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single, Ascending, Oral Doses of AZD2551 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Safety and tolerability of AZD2551 by assessment of vital signs, ECG, laboratory variables and adverse events
研究概览
简要总结
The purpose of this study is to determine how well tolerated and safe AZD2551 is at different dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is absorbed into and cleared by the body
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed, written and dated informed consent prior to any study specific procedures
- •Be willing to use barrier methods of contraception unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods
- •Have a body mass index between 18 and 30 kg/m2 inclusive and weight at least 50kg and no more than 100kg
排除标准
- •Use of any prescribed or non-prescribed medication during the two weeks prior to the administration of study drug
- •History or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
- •Any impairment of kidney function or laboratory results for markers of kidney function that are outside the reference range and considered clinically significant
- •Underlying musculoskeletal symptoms of unknown origin, subjects with shoulder girdle musculoskeletal symptoms or Dupuytrens syndrome
研究组 & 干预措施
1
Experimental
干预措施: AZD2551 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of AZD2551 by assessment of vital signs, ECG, laboratory variables and adverse events
时间窗: Baseline assessments at Visit 1 (enrolment). Assessments pre-dose and at defined timepoints post-dose at Visit 2. Follow up assessment at Visit 3
Pharmacokinetic profile: concentration of AZD2551 in blood
时间窗: Samples taken at Visit 2. Up to 15 samples to be taken at defined timepoints post-dose, plus one sample pre-dose
次要结局
- Pharmacokinetic profile: concentration of AZD2551 in urine(Samples collected at Visit 2 from pre-dose up to 48 hours post-dose)
研究者
研究点 (1)
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