An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Albiglutide in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide
研究概览
简要总结
This open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.
详细描述
This Phase I open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male healthy volunteers in good health
- •no clinically significant diseases or clinically significant abnormal laboratory values
- •body mass index (BMI) is >/=18 kg and ≤30 kg/m2
- •nonsmoker
排除标准
- •positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •any clinically relevant abnormality
- •history of any anaphylactic reaction to any drug
- •history of significant cardiovascular or pulmonary dysfunction
- •history of excessive bleeding
- •current or chronic history of liver disease
- •history of alcohol or substance abuse
- •history of thyroid disease or dysfunction
- •history of gastrointestinal surgery or disease
- •history of pancreatitis
- •previously received any GLP-1 mimetic compound (e.g., exenatide)
研究组 & 干预措施
warfarin plus albiglutide
A single dose of 25mg warfarin on day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 25mg warfarin on day 45.
干预措施: warfarin plus albiglutide (Biological)
结局指标
主要结局
The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide
时间窗: 52 days
次要结局
- The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR).(52 days)