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临床试验/NCT04156750
NCT04156750已完成1 期

Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects

Eli Lilly and Company1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年11月20日最近更新:
适应症
干预措施
相关药物

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

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)

Other

Metformin given orally. (Part B is optional.)

干预措施: Metformin (Drug)

LY3556050 (Part A)

Experimental

LY3556050 administered orally.

干预措施: LY3556050 (Drug)

Placebo (Part A)

Placebo Comparator

Placebo administered orally.

干预措施: Placebo (Drug)

Iohexol (Part B)

Other

Iohexol given intravenously (IV). (Part B is optional.)

干预措施: Iohexol (Drug)

LY3556050+ Iohexol (Part B)

Experimental

Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)

干预措施: LY3556050 (Drug)

LY3556050+ Iohexol (Part B)

Experimental

Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)

干预措施: Iohexol (Drug)

LY3556050 + Metformin (Part B)

Experimental

Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)

干预措施: LY3556050 (Drug)

LY3556050 + Metformin (Part B)

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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