NCT01114152已完成1 期
A Phase I, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Intravenous AZD9742 in Healthy Male and Female 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
- 35
- 试验地点
- 1
- 主要终点
- Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
研究概览
简要总结
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects
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
- 23 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •female (non-childbearing potential)
- •Body mass index (BMI) : 17 to 27 kg/m 2
排除标准
- •History of 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 results or the subject's ability to participate in the study
- •History or presence of gastrointestinal, hepatic, or renal disease or any otherHistory or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- •Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
研究组 & 干预措施
1
Experimental
Dose level A, B, C and optional Dose level D and E: single administration and one to three times daily for 6 days (Japanese n=8)
干预措施: AZD9742 (Drug)
2
Placebo Comparator
placebo given (2 subjects in each dose group)
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
时间窗: collected prior to treatment, during treatment and follow-up for a total of 18-22 days
次要结局
- Characterize the Pharmacokinetics of AZD9742 in blood and urine(PK-sampling during 14 pre-defined study days for PK profiling)
研究者
研究点 (1)
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