NCT00818129已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7295 Following Single and Multiple Ascending Oral Dose Administration in Healthy Male Japanese Subjects
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
- 62
- 试验地点
- 1
- 主要终点
- AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature
研究概览
简要总结
The primary objective of this study is to investigate the safety and tolerability of single and multiple oral doses of AZD7295 in healthy male Japanese subjects. This will be done by comparing the effect of AZD7295 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD7295 in 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
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 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
- •Healthy male Japanese volunteers aged 20-55 years
- •BMI between 18 and 27 kg/m2
- •Have negative screens for HIV, hepatitis B and C viruses and syphilis
排除标准
- •Use of prescribed medication within 2 weeks prior to the dose of study medication
- •Participation in another study that included drug treatment within 16 weeks before the start of the present study.
- •History or presence of gastrointestinal, hepatic or renal disease or a condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- •History of severe food or drug allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged relevant by the investigator.
研究组 & 干预措施
1
Experimental
干预措施: AZD7295 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature
时间窗: During the study
次要结局
- Pharmacokinetics (Cmax, tmax, AUC, AUC0-t, CL/F, Vss/F, t1/2 , Cmin, Rac, etc)(Frequent sampling until 72 hours after single administration in Single Dose Part and until 72 hours after last administration (6 days administration) in Multiple Dose Part)
研究者
研究点 (1)
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