NCT01171105已完成1 期
A Phase I, Double-blind, Randomized, Placebo-controlled', Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD5213 After Administration of Multiple Ascending Doses for 10 Days in Healthy Male and Non-fertile Female Volunteers
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
- 73
- 试验地点
- 1
- 主要终点
- Adverse events, vital signs, physical (including neurological) examinations, clinical laboratory variables, electrocardiograms, telemetry, sleep diary (temporal and qualitative aspects), and the Columbia-Suicide Severity Rating Scale
研究概览
简要总结
- The main purpose of this study is to assess the safety and tolerability of AZD5213 after multiple oral doses.
- Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves your body and how your body acts on the study drug) of AZD5213 in your blood and urine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and non-fertile female healthy volunteers aged 18-50 years and 65-80 years inclusive at day of enrollment with suitable veins for cannulation or repeated venipuncture.
- •Male healthy volunteers should be willing to use barrier contraception during sexual intercourse, ie condoms, even if partner is using contraceptive method, from the first day of dosing until 3 months after the last dosing with AZD
- •Body weight of ≥50 to ≤100 Kg and Body Mass Index (BMI) ≥18 to ≤30 kg/m2.
排除标准
- •History and presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disorders.
- •History or presence of gastrointestinal (including irritable bowel disease), hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. Surgery on gastrointestinal tract.
- •History of previous or ongoing psychiatric disorders.
研究组 & 干预措施
1
Experimental
AZD5213 (dose escalating)
干预措施: AZD5213 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo to AZD5213 (Drug)
结局指标
主要结局
Adverse events, vital signs, physical (including neurological) examinations, clinical laboratory variables, electrocardiograms, telemetry, sleep diary (temporal and qualitative aspects), and the Columbia-Suicide Severity Rating Scale
时间窗: Up to 30 days screening period. Residential period will be 14 days. Follow up period will be 7 to 10 days after dose
次要结局
- Time to reach steady state(Frequent timepoints within 48 hours of multiple dose day 1 and day 12.)
- Multiple-dose PK and dose proportionality(Frequent timepoints within 48 hours of multiple dose day 1 and day 12.)
- Degree of accumulation and time dependancy of orally-administered AZD5213(Frequent timepoints within 48 hours of multiple dose day 1 and day 12.)
研究者
研究点 (1)
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