An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin 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
- 40
- 试验地点
- 1
- 主要终点
- The effect of albiglutide on the pharmacokinetics of simvastatin
研究概览
简要总结
This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.
详细描述
This Phase I open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.
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
- •no clinically significant diseases or clinically significant abnormal laboratory values
- •females must be of non-childbearing potential
- •body mass index (BMI) is >/=18 kg and ≤30 kg/m2
- •nonsmoker
- •negative drug screen
排除标准
- •positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- •any clinically relevant abnormality
- •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 dysfunction or disease
- •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
simvastatin plus albiglutide
A single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38.
干预措施: simvastatin plus albiglutide (Biological)
结局指标
主要结局
The effect of albiglutide on the pharmacokinetics of simvastatin
时间窗: 42 days
次要结局
- The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide(42 days)