NCT01283984已完成1 期
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD2115 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
- 96
- 试验地点
- 1
- 主要终点
- To evaluate the frequency of adverse events of inhaled single doses of AZD2115
研究概览
简要总结
AZD2115 Single Ascending Dose Study
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
- •Healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
- •Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the day of dosing until 3 months after dosing with the investigational product.
- •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 able to inhale from a Spira nebuliser according to given instructions
排除标准
- •Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
- •Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following:
- •PR (PQ) interval prolongation >200 ms (first degree AV block)
- •Intermittent second or third degree AV block (based on screening or pre-dose ECG)
- •Incomplete, full or intermittent bundle branch block (QRS <110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy)
- •Abnormal T wave morphology, particularly in the protocol defined primary lead
- •Dropped beats
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2115 and/or excipients
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Serum potassium concentration of <3.80 mmol/L on admission (Day -1)
研究组 & 干预措施
1
Experimental
AZD2115
干预措施: AZD2115 (Drug)
2
Placebo Comparator
Placebo to AZD2115
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
时间窗: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
时间窗: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the vital signs of inhaled single doses of AZD2115
时间窗: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the physical examination of inhaled single doses of AZD2115
时间窗: Measurements will be taken at follow up 7-13 days post dose.
To evaluate the ECG of inhaled single doses of AZD2115
时间窗: Measurements will be taken at follow up 7-13 days post dose.
次要结局
- To assess the pharmacokinetics of a single dose of AZD2115 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax).(Frequent sampling occasions during study days, before and up to 48 h after dosing)
- To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - FEV1(Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.)
- To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - potassium(Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.)
- To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - glucose(Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.)
- To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - systolic and diastolic blood pressure(Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.)
- To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - pulse, heart rate(Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.)
- To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - QTcF(Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.)
研究者
研究点 (1)
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