An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Digoxin 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
- 30
- 试验地点
- 2
- 主要终点
- The pharmacokinetic parameters of digoxin with and without albiglutide
研究概览
简要总结
This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects.
详细描述
This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects. Subjects will receive a single dose of digoxin on Day 1 followed by 5 weekly subcutaneously injected doses of albiglutide and a second single dose of digoxin on Day 38. To determine the plasma pharmacokinetic parameters of digoxin after drug administration alone and after multiple doses of albiglutide, blood samples will be collected after each dose of digoxin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers
- •female subjects must be of nonchildbearing potential
- •no clinically significant diseases or clinically significant abnormal laboratory values
- •body mass index (BMI) is >/=18 kg and ≤30 kg/m2
- •a nonsmoker
排除标准
- •positive test results for hepatitis B, hepatitis C or human immunodeficiency virus
- •female subject is pregnant or breast-feeding
- •history of any anaphylactic reaction to any drug
- •history of significant cardiovascular or pulmonary dysfunction
- •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
- •history of cholecystitis or other gallbladder disease
- •previously received any GLP-1 mimetic compound (e.g., exenatide)
结局指标
主要结局
The pharmacokinetic parameters of digoxin with and without albiglutide
时间窗: 38 days
次要结局
- Safety of digoxin with and without albiglutide(38 days)