NCT01332214已完成1 期
A Randomised, Single-blind, Placebo-controlled Single-centre Phase I Study in Healthy Male Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD2820 After Single Ascending Doses
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
- 90
- 试验地点
- 1
- 主要终点
- Safety variables ( Adverse events, Vital signs, ECG, EEG, Regiscan, Safety labs.)
研究概览
简要总结
This is a randomised, single-blind, placebo-controlled Phase I study to investigate the safety, tolerability and pharmacokinetics after administration of single doses of AZD2820 to healthy male subjects.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures.
- •Healthy male subjects aged ≥20 - ≤45 years with suitable veins for cannulation or repeated venepuncture.
- •Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
- •Have a body mass index (BMI) between≥ 18 and ≤30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
- •Provision of signed, written and dated informed consent for genetic research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •A history of erectile dysfunction or anatomic abnormality of the penis (eg, cavernosal fibrosis, Peyronie's disease, or plaques) which interferes with normal erectile function
- •Predisposition or history of priapism (eg, sickle cell anemia or trait).
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
研究组 & 干预措施
AZD2820
Experimental
干预措施: AZD2820 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables ( Adverse events, Vital signs, ECG, EEG, Regiscan, Safety labs.)
时间窗: Assessments performed multilpe times from the morning day 1 before dose until day 3. And then once at the follow up after 14-18 days
次要结局
- To evaluate the pharmacokinetics of AZD2820 and assess the dose proportionality of the pharmacokinetics following single ascending doses of AZD2820 by assessment Cmax, tmax, t1/2 , AUC, CL/F, Ae and CLR.(Blood samples will be taken multiple times from the morning day 1 before dose until day 2)
研究者
研究点 (1)
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