NCT00979849已完成1 期
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD8683 After Single Ascending Doses 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
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 130
- 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 aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8683 following single ascending dose administrations 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 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
- •Any clinically significant abnormalities at screening examinations
- •Use any prescribed or non-prescribed medication
研究组 & 干预措施
A
Experimental
AZD8683
干预措施: AZD8683 (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, before and up to 48 h after dosing, and at a follow-up visit 7-13 days after dosing.
次要结局
- Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (λz), terminal half-life (t½λz)(Frequent sampling occasions during study days, before and up to 48 h after dosing.)
- Pharmacokinetics: Area under the plasma concentration-time curve from zero to the time of the last measurable concentration (AUC(0-t)) and from zero to infinity (AUC), apparent plasma clearance (CL/F)(Frequent sampling occasions during study days, before and up to 48 h after dosing.)
- Pharmacokinetics: Apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT), amount of drug excreted unchanged (Ae; % dose), and renal clearance (CLR).(Frequent sampling occasions during study days, before and up to 48 h after dosing.)
- Pharmacodynamics: Lung function by spirometry (forced expiratory volume in the first second [FEV1] and forced vital capacity [FVC]), blood pressure, pulse, QTc, and heart rate.(Frequent sampling occasions during study days, before and up to 48 h after dosing.)
研究者
研究点 (1)
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