A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-LY3871801 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Urinary Excretion of LY3871801 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 (LY3871801), 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 9 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 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 18.5 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 LY3871801, related compounds, or any components of the formulation, or a history of significant atopy
- •Have received or intend to receive any vaccination within 30 days prior to dosing until the follow-up phone call
- •Have participated in a radiolabeled drug study, where exposures are known to the investigator or designee, within 4 months prior to check-in, or participated in a radiolabeled drug study, where exposures are not known to the investigator or designee, within 6 months prior to check-in
研究组 & 干预措施
[14C]-LY3871801
Single dose of [¹⁴C]-LY3871801 administered orally
干预措施: [14C]-LY3871801 (Drug)
结局指标
主要结局
Urinary Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
时间窗: Predose up to Day 7 post dose
Urinary Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
时间窗: Predose up to Day 7 post dose
Fecal Excretion of LY3871801 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time From zero to Infinity (AUC [0-∞]) of [¹⁴C]-LY3871801(Predose up to Day 7 post dose)
- PK: AUC [0-∞] of Total Radioactivity in Plasma and Whole Blood(Predose up to Day 7 post dose)
- PK: Maximum Concentration (Cmax) of [¹⁴C]-LY3871801(Predose up to Day 7 post dose)
- PK: Cmax of Total Radioactivity(Predose up to Day 7 post dose)
- Total Radioactivity Recovered in Urine, Feces, and Expired Air(Predose up to Day 7 post dose)
- Total Number of Metabolites of LY3871801(Predose up to Day 7 post dose)