NCT00861718已完成1 期
A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Healthy Subjects
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
- 40
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses to healthy male subjects and female subjects of non-childbearing potential.
研究概览
简要总结
Multiple Ascending Dose Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of Informed Consent
- •Healthy male subjects and female subjects (of non-child bearing potential)
- •with suitable veins for cannulation or repeated venipuncture
排除标准
- •Inability to understand or cooperate with given information
- •Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
- •History of seizure (including infancy febrile seizures) or family history of seizure
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
AZD7268
Experimental
干预措施: AZD7268 (Drug)
结局指标
主要结局
To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses to healthy male subjects and female subjects of non-childbearing potential.
时间窗: Safety assessments are made at each visit, at least daily, during the study.
次要结局
- To characterize the pharmacokinetics of AZD7268 in plasma.(Serial blood samples for pharmacokinetic analysis will be collected on Days 1,2,3 and Days 9, 10, and 11 of the study. Additional pharmacokinetic samples will be collected on Days 6, 7, and 8)
研究者
研究点 (1)
Loading locations...
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