NCT00796965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 After Single 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
- 48
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of single ascending dose administration of AZD7268 when given orally to healthy male subjects and female subjects of non-childbearing potential.
研究概览
简要总结
Single 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
- Triple (Participant, 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
- •Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
- •Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis
研究组 & 干预措施
1
Experimental
干预措施: AZD7268 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of single ascending dose administration of AZD7268 when given orally 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 and urine.(Blood and urine samples will be taken during the study.)
- To assess the effect of food on the safety and pharmacokinetic profile of AZD7268.(Safety assessments and blood and urine samples will be taken throughout the study.)
研究者
研究点 (1)
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