NCT00757419已完成1 期
A Phase 1 Single Centre Single-blind Randomised Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD3355 After Administration of Single Ascending Doses and Multiple Repeated 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
- 54
- 试验地点
- 1
- 主要终点
- Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values)
研究概览
简要总结
The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo ("inactive substance"). Safety and tolerability variables will be closely monitored throughout the 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
- Single (Participant)
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
- •Subjects without concurrent diseases who do not require any medical treatments
- •Provision of signed informed consent.
排除标准
- •History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
- •Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
- •History of clinically significant orthostatic reaction or syncope
- •Clinically important abnormalities related to the heart function
研究组 & 干预措施
1
Experimental
干预措施: AZD3355 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables (Adverse event reporting, ECG, blood pressure, pulse rate, urine weight and osmolality, body temperature, blood and urine laboratory values)
时间窗: During the study
次要结局
- Pharmacokinetic variables(Several occasions during the study days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I Trial of AZD3965 in Patients With Advanced CancerAdult Solid TumorDiffuse Large B Cell LymphomaBurkitt LymphomaNCT01791595Cancer Research UK53
已完成
1 期
Open Label Prostate Cancer StudyProstate CancerNCT01162395AstraZeneca64
已完成
1 期
Dose-escalating AZD1775 + Concurrent Radiation + Cisplatin for Intermediate/High Risk HNSCCCarcinoma, Squamous Cell of Head and NeckNCT02585973UNC Lineberger Comprehensive Cancer Center12
已完成
1 期
Safety and Tolerability of AZD5148 in Japanese ParticipantsClostridioides Difficile InfectionNCT06639997AstraZeneca16
已完成
1 期
Study of an Extended Release (ER) Tablet, Single and Repeated DosingHealthyNCT00689039AstraZeneca94