Disposition of [14C]-LY3556050 Following Oral Administration in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
研究概览
简要总结
The main purpose of this study is to evaluate how much of the study drug (LY3556050), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 58 days 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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants who are overtly healthy as determined by medical evaluation
- •Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive
- •Males who agree to use highly effective or effective methods of contraception
排除标准
- •Have known allergies to LY3556050, related compounds, or any components of the formulation of LY3556050, or history of significant atopy
- •Have clinically significant abnormal BP and/or pulse rate as determined by the investigator
- •Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing
研究组 & 干预措施
[14C]-LY3556050
Single dose of [¹⁴C]-LY3556050 administered orally
干预措施: [14C]-LY3556050 (Drug)
结局指标
主要结局
Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
时间窗: Predose up to Day 21 post dose
Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
时间窗: Predose up to Day 21 post dose
Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
次要结局
- PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood(Predose up to Day 21 post dose)
- PK: Maximum Concentration (Cmax) of LY3556050 in Plasma(Predose up to Day 21 post dose)
- PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of LY3556050 in Plasma(Predose up to Day 21 post dose)
- Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)(Predose up to Day 7 post dose)
- Pharmacokinetics (PK): Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3556050 in Plasma(Predose up to Day 21 post dose)
- PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood(Predose up to Day 21 post dose)
- PK: Cmax of Total Radioactivity in Plasma and Blood(Predose up to Day 21 post dose)
- Total Number of Metabolites of LY3556050(Predose up to Day 7 post dose)