NCT01711775已完成1 期
A Single-center, Non-randomized, Open-label Study to Assess the Pharmacokinetics of Aleglitazar (RO0728804) After Administration of Single and Multiple Oral Doses of 150 µg Tablet in Healthy Chinese 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
- 入组人数
- 16
- 主要终点
- Pharmacokinetics: Day 14 (steady-state) area under the concentration-time curve (AUC 0-24)
研究概览
简要总结
This single-center, non-randomized, open-label study will assess the pharmacokinetics of aleglitazar after administration of single and multiple oral doses in healthy Chinese volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening and a 2-week follow-up, is up to 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male Chinese volunteers, 18 to 45 years of age inclusive at screening
- •Subjects have to be healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory measurements performed at screening
- •Body mass index (BMI) 19 to 24 kg/m2 inclusive
- •Female subjects who are not surgically sterile must be willing to use effective method of contraception as defined by protocol throughout the study and for 30 days after the last dosing
排除标准
- •Any significant allergic reactions or multiple allergies
- •Diagnosed or treated malignancy (except for treated cases of basal skin cancer or in situ carcinoma of the cervix) within the past 5 years
- •Any major illness within 2 months prior to first dosing or febrile illness within 14 days prior to first dosing
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Any clinically relevant history of alcohol and/or other substance abuse or addiction within the last 2 years
- •Pregnant or lactating women, or women who have a positive pregnancy test
- •Regular smoker with consumption of more than 10 cigarettes per day or equivalent amount of tobacco
- •Participation in an investigational drug or device study within 3 months prior to the first dosing
研究组 & 干预措施
Aleglitazar
Experimental
干预措施: aleglitazar (Drug)
结局指标
主要结局
Pharmacokinetics: Day 14 (steady-state) area under the concentration-time curve (AUC 0-24)
时间窗: Day 14 pre-dose and up to 24 hours post-dose
Pharmacokinetics: Day 14 (steady-state) maximum concentration (Cmax)
时间窗: Day 14 pre-dose and up to 24 hours post-dose
次要结局
- Safety: Incidence of adverse events(approximately 10 months)
- Pharmacokinetics: Maximum concentration (Cmax)(18 days)
- Single-dose pharmacokinetics: Area under the concentration-time curve (AUC)(up to 5 days)
- Single-dose pharmacokinetics: Half-life (t1/2)(up to 5 days)
- Pharmacokinetics: Apparent oral plasma clearance (CL/F)(18 days)
- Pharmacokinetics: Apparent volume of distribution (VZ/F)(18 days)
- Single-dose pharmacokinetics: Time to maximum observed plasma concentration (tmax)(up to 5 days)
- Pharmacokinetics: Accumulation index (Rac)(18 days)
研究者
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