A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of AZD8566 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile: concentration of AZD8566 in blood
研究概览
简要总结
The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent.
- •Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
- •Females who are permanently or surgically sterile or postmenopausal and males.
排除标准
- •Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
- •History of any convulsions or seizures
- •History of infection or at risk of infection due to recent surgery or trauma
- •History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug
研究组 & 干预措施
1
干预措施: AZD8566 (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic profile: concentration of AZD8566 in blood
时间窗: Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10
Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events
时间窗: Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.
次要结局
- Pharmacokinetic profile: concentration of AZD8566 in urine(Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10.)