An Open-Label Study in Healthy Participants to Evaluate the Effect of LY3556050 on Metformin Pharmacokinetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- PK: Maximum Observed Drug Concentration (Cmax) of Metformin
研究概览
简要总结
The main purpose of this study is to evaluate how much Metformin gets into the bloodstream and how long the body takes to get rid of it when it is administered orally in combination with LY3556050 in healthy participants. Iohexol will be administered to evaluate kidney function. Each enrolled participant will remain in the study for up to 7 weeks including the screening period.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants who are overtly healthy as determined by medical evaluation
- •Participants with body weight of at least 50 kilograms (kg) or more and have a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²)
- •Have an ECG at screening considered to be within acceptable limits by the investigator
- •Male participants who agree to use contraception and female participants of child bearing potential who agree to use contraception and women not of child bearing potential may participate.
排除标准
- •Women who are lactating
- •Have known allergies or contraindications to LY3556050, metformin, iodine, iohexol, or other contrast agents, related compounds or any components of their formulation, or history of significant atopy
- •Have a history, or ECG findings, of clinically significant bradycardia, heart block, tachycardia, sick sinus syndrome/sinoatrial block, first-degree AV block, or second- or third-degree AV block, bundle branch block or other tachy- or brady-arrhythmias; o rhave any other abnormality in the 12-lead ECG that, in the opinion of the investigator, confounds assessment of QT interval or increases the risks associated with participating in the study
- •Have active or a history of gastritis or peptic ulcer disease
研究组 & 干预措施
LY3556050 + Metformin + Iohexol
LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV).
干预措施: LY3556050 (Drug)
LY3556050 + Metformin + Iohexol
LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV).
干预措施: Metformin (Drug)
LY3556050 + Metformin + Iohexol
LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV).
干预措施: Iohexol (Drug)
结局指标
主要结局
PK: Maximum Observed Drug Concentration (Cmax) of Metformin
时间窗: Predose on day 1 through 13 days postdose
PK: Cmax of Metformin
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Metformin
时间窗: Predose on day 1 through 13 days postdose
PK: AUC of Metformin
次要结局
未报告次要终点