NCT01121302已完成1 期
A Phase I Study of Orally-administered AZD5213 in Healthy Males and Non-fertile Females Including Randomized, Double-blind, Placebo-controlled, Parallel-group Assessment of the Safety, Tolerability & PK of Single Ascending Dose (Part 1) & an Open-label Assessment of Effect of Food on the PK (Part 2)
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
- 88
- 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 single 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.
One group of subjects will be studied to see how food affects the pharmacokinetics (PK) of AZD5213 in the blood and urine. They will receive AZD5213 once after fasting overnight and then return to the clinic to receive AZD5213 after eating a high fat breakfast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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, gastorintestinal 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
dose escalating
干预措施: AZD5213 (Drug)
2
Placebo Comparator
placebo
干预措施: Placebo (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: AE will be collected from admission on Day -1 until follow-up
次要结局
- Part 1 : Investigate single-dose PK and dose proportionality of orally-administered AZD5213(Frequent timepoints within 48 hours of single dose administration)
- Part 2 Investigate the potential effect of food on AZD5213 PK after administration of AZD5213 as an oral solution(Frequent timepoints after volunteer consumes a high fat, high calorie breakfast, per FDA guidelines.)
研究者
研究点 (1)
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