NCT01086813撤回1 期
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly (=65 Years) Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 主要终点
- To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043
研究概览
简要总结
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly(=65 years) Healthy Volunteers
详细描述
Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly (=65 years) Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pre-anaesthesia assessment judged without remarks by the investigator.
- •ASA physical status category 1 to 2 (up to and including 3 depending on applicable patient category)
排除标准
- •Lack of a normal range of enzyme activity for BuChE
- •Known or suspected history of hypersensitivity to drugs with a similar chemical structure or class to AZD3043 (e.g., emulsion-based products like Diprivan,Intralipid), allergies to soybean or peanut products or any other drugs intended for use during th
- •Prolonged QTcF >450 ms or shortened QTcF <350 ms or family history of long QT syndrome.
研究组 & 干预措施
1
Experimental
干预措施: AZD3043 (Drug)
结局指标
主要结局
To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043
时间窗: Heartrate, Bloodpressure, Telemetry, ECG, EtCO2, SPO2, BIS, Respiratory frequency every minute during a 1h session
次要结局
- To evaluate the PK of AZD3043 and its main metabolite (THRX-108893) in venous blood samples(During 24h)
- To evaluate the onset, level and recovery from sedation/anaesthesia(During 24h)
研究者
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