NCT00829127撤回1 期
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Oral Doses of AZD8075 in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 入组人数
- 27
- 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 the study are to evaluate the safety, tolerability and pharmacokinetics of AZD8075 in healthy male subjects at increasing doses when given for 14 days
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 procedures
- •Have a body mass index (BMI) between 19 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
- •Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
- •Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
- •Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2
研究组 & 干预措施
1
Experimental
干预措施: AZD8075 (Drug)
2
Placebo Comparator
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: daily
次要结局
- characterise the multiple dose PK of AZD8075 and assess the time required to reach steady state, the degree of accumulation and the time dependency of the PK(daily)
研究者
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