A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 48
- 主要终点
- To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo in healthy male Japanese subjects by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEG.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability after repeated ascending doses of AZD7325 in Japanese healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Japanese subjects
排除标准
- •Significant illness, as judged by the investigator, within 2 weeks of Day 1
- •Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit
- •Blood loss in excess of 200 mL within 30 days of Day 1, in excess of 400 mL within 90 days of Day 1, or in excess of 1200 mL within 1 year of Day 1
- •Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor
研究组 & 干预措施
1
Low dose or placebo, twice daily
干预措施: AZD7325 (Drug)
1
Low dose or placebo, twice daily
干预措施: Placebo (Drug)
2
Low dose or placebo, once daily
干预措施: AZD7325 (Drug)
2
Low dose or placebo, once daily
干预措施: Placebo (Drug)
3
Middle dose or placebo, twice daily
干预措施: AZD7325 (Drug)
3
Middle dose or placebo, twice daily
干预措施: Placebo (Drug)
4
High dose or placebo, once daily
干预措施: AZD7325 (Drug)
4
High dose or placebo, once daily
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo in healthy male Japanese subjects by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEG.
时间窗: Observations/Assessments are made at each visit (Screening visit, Treatment visit (Day 1-Day 9) and Follow-up visit).
次要结局
- To evaluate and characterize the pharmacokinetics of AZD7325 when given orally in multiple ascending doses by assessment of drug concentration in plasma and urine.(Blood and urine samples will be taken before and after study drug administration (up to 48 hours post dose).)
- To evaluate the effects on VAS, Ataxia assessments and CogState Battery (cognition).(Observations/Assessments are made during the treatment visit.)