A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study in Healthy Japanese Male Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD4017 After Single Ascending Oral Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
研究概览
简要总结
The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to Japanese healthy male volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 written and dated informed consent
- •BMI between 19 and 27 kg/m2
- •Subjects must be willing to use barrier methods of contraception
排除标准
- •History of any clinical significant disease
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Laboratory blood sample result showing elevated liverenzymes (ASAT, ALAT) and muscle enzymes (CK).
研究组 & 干预措施
1
AZD4017 in ascending doses (start dose 2mg)
干预措施: AZD4017 (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
时间窗: The variables will be measure predose and the repeatedly during the following 47 hours after dosing
次要结局
- Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F)(Blood samples for determination of AZD4017 concentartion will be taken predose and repeatedly during the 47 hours post dose)