NCT01445782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 Multiple Ascending Inhaled Doses of AZD2115 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
- 32
- 试验地点
- 1
- 主要终点
- Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), lung function (Spirometry), physical examination, safety labs
研究概览
简要总结
This study will investigate the safety and tolerability of AZD2115 following administration of multiple ascending doses.
详细描述
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Inhaled Doses of AZD2115 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
- Double (Participant, 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 and spermicide, from the day of first administration of the AZD2115 until 3 months after administration and must not donate sperm for 3 months after follow-up
- •Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
排除标准
- •Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
- •Systolic BP >140 mmHg
- •Diastolic BP >90 mmHg
- •Heart rate <40 or >85 bpm
- •Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
- •Serum potassium concentration of < 3.80 mmol/L on admission (Day -1)
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with the same class to AZD2115 or to excipients
- •History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
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
Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), lung function (Spirometry), physical examination, safety labs
时间窗: baseline, up to 30 days
No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis
次要结局
- Description of the pharmacokinetics (PK) of AZD2115 in terms of area under the curve over the time (AUC) and maximum concentration (Cmax) and terminal half-life(day 1)
- Description of pharmacokinetics (PK) of AZD2115 in terms of Cmax, area under the plasma concentration-time curve from zero to the end of the dosing interval (AUC(0-τ))(day 17)
- Description of achievement of plasma drug concentration steady state(PK samples collected pre-dose on day 1, day 4, day 6, day 10, day 14, day 17)
- Description of pharmacodynamics of AZD2115 in terms of FEV1 (forced expiratory volume in the first second), FVC (forced vital capacity), potassium, glucose, systolic and diastolic blood pressure, pulse rate, heart rate, QTcF(day 1, day 17)
研究者
研究点 (1)
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