NCT01217905已完成1 期
A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Single and Multiple Ascending Doses in Healthy Male Japanese 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
- 36
- 试验地点
- 1
- 主要终点
- Investigate the safety and tolerability of AZD7687 following administration of single and multiple doses
研究概览
简要总结
This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound AZD7687. It will also assess how the body handles the drug and how it responds to the drug following single dose followed by multiple dosing over 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Suitable veins for cannulation or repeated venipuncture
- •Have a body mass index (BMI) between 19 and 35 kg/m2 and weigh at least 50 kg and no more than 90 kg
- •Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product
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
- •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
1
Experimental
干预措施: AZD7687 (Drug)
结局指标
主要结局
Investigate the safety and tolerability of AZD7687 following administration of single and multiple doses
时间窗: From screening period to follow-up visit 45 days (Maximum).
次要结局
- Evaluate the pharmacokinetics (PK) (plasma and urine) of AZD7687 and it´s glucuronic acid metabolite (AZ13128940) after single and multiple doses(Before dose and repeatedly to follow-up visit)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069HealthyNCT01100047AstraZeneca63
已完成
1 期
Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy VolunteersCongenital Bleeding DisorderHealthyNCT00822185Novo Nordisk A/S32
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese VolunteersDiabetesDiabetes Mellitus, Type 2NCT01620463Novo Nordisk A/S32
已完成
1 期
Safety and Tolerability of Liraglutide in Healthy Japanese VolunteersHealthyDiabetesNCT01620476Novo Nordisk A/S24
已完成
1 期
Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese VolunteersAcquired Bleeding DisorderCardiac Surgery Requiring Cardiopulmonary BypassHealthyNCT01153997Novo Nordisk A/S24