NCT00967356终止1 期
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD5985 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
- 72
- 试验地点
- 1
- 主要终点
- Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
研究概览
简要总结
The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.
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, Care Provider, Investigator)
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 procedure
- •Healthy male subjects aged 18 to 45 years (inclusive)
- •Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- •Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start
排除标准
- •History or presence of any clinically significant disease or disorder in the opinion of the investigator
- •Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
- •Participation in another investigational drug study within 3 months before Visit 2 or participation in a methodological study (no drug) 1 month prior to Visit 2
研究组 & 干预措施
A
Experimental
AZD5985
干预措施: AZD5985 (Drug)
B
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
时间窗: Frequent sampling occasions during study days
次要结局
- Pharmacokinetic variables(Frequent sampling occasions during study days)
研究者
研究点 (1)
Loading locations...
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