Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Part A - Double-blind. Part B - Open label.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females of nonchild bearing potential, as determined by medical history
- •Have safety laboratory results within normal references ranges
- •Weight at least 50 kilograms (kg)
排除标准
- •Have known allergies to LY3556050, iodine, metformin and related compounds
- •Abnormal electrocardiogram (ECG) or blood pressure at screening
- •Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders
- •Show evidence of active renal disease with estimated glomerular filtration rate (GFR) <90 milliliters per minute per 1.73 meters squared
研究组 & 干预措施
Metformin (Part B)
Metformin given orally. (Part B is optional.)
干预措施: Metformin (Drug)
LY3556050 (Part A)
LY3556050 administered orally.
干预措施: LY3556050 (Drug)
Placebo (Part A)
Placebo administered orally.
干预措施: Placebo (Drug)
Iohexol (Part B)
Iohexol given intravenously (IV). (Part B is optional.)
干预措施: Iohexol (Drug)
LY3556050+ Iohexol (Part B)
Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)
干预措施: LY3556050 (Drug)
LY3556050+ Iohexol (Part B)
Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)
干预措施: Iohexol (Drug)
LY3556050 + Metformin (Part B)
Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)
干预措施: LY3556050 (Drug)
LY3556050 + Metformin (Part B)
Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)
干预措施: Metformin (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Final Follow-up (up to Week 9)]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050(Baseline through Day 17)
- PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ)(Baseline through Day 17)