NCT00738959已完成1 期
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0328 in Healthy Young Japanese and Caucasian Male Volunteers After Oral Single and Multiple Ascending Doses
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
- 64
- 试验地点
- 1
- 主要终点
- Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements
研究概览
简要总结
This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects.
- •Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.
排除标准
- •History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study.
- •Participation in another study within 12 weeks before the first administration of the investigational product.
- •Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product.
研究组 & 干预措施
1
Experimental
干预措施: AZD0328 (Drug)
结局指标
主要结局
Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements
时间窗: During the whole treatment period
次要结局
- PK variables(Several samples during the study days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult VolunteersHealthyNCT06334211Foresee Pharmaceuticals Co., Ltd.64
已完成
1 期
Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy VolunteersHealthy Human VolunteersNCT00813670Xenon Pharmaceuticals Inc.64
已完成
1 期
To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy VolunteersAutosomal Dominant Polycystic KidneyNCT04908462AceLink Therapeutics, Inc.69
已完成
1 期
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult ParticipantsHealthy VolunteerNCT03943056Biogen64
已完成
1 期
Study of the Safety of Intravenous ArtesunateMalaria, CerebralMalariaNCT00292929U.S. Army Medical Research and Development Command40