NCT00918515已完成1 期
A Phase I, Single-Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After Single Ascending Doses 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
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Assessment of Vital signs data, heart rate, electrocardiogram (ECG)
研究概览
简要总结
This is a Phase I, single centre, open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending doses in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Pre-dose assessment judged without remarks by the investigator
- •Have a Body Mass Index (BMI) between 19 and 30 kg/m2 and weight at least 50kg and no more than 100kg
排除标准
- •After adequate time (at least 15 minutes) of rest in supine position, abnormal vital signs defined as any of the following:·
- •Systolic blood pressure (BP) >140 mm Hg.·
- •Diastolic BP >90 mm Hg.
- •Heart rate <=55 or >85 beats per minute
- •Subjects with compromised airway or respiratory function as evidenced by the presence of Class 3 or 4 Airway, Sleep Apnoea, Neck circumference > 16.5 inches (42 cm), Asthma, Active or recent (2 weeks) respiratory infection, or known chronic respiratory infection, or known chronic respirator
- •Lack of a normal phenotype for butyrylcholinesterase (pseudo-cholinesterase)
研究组 & 干预措施
AZD3043
Experimental
Intravenous solution
干预措施: AZD3043 (Drug)
结局指标
主要结局
Assessment of Vital signs data, heart rate, electrocardiogram (ECG)
时间窗: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.
Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency, volume and pattern, occurrence of apnoea;
时间窗: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.
次要结局
- PK parameters for AZD3043: Cmax (Css), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tlast and mean residence time in arterial and venous plasma.(Arterial: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150 min postdose. Venous: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150, 270 min, 8h, 24h postdose.)
- PK parameters for the metabolite (THRX 108893): Cmax (Css), AUClast, AUC, tmax, tlast, lz and t½lz in venous plasma(29 min, 45 min and 150 min post dose)
研究者
研究点 (1)
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