A Single-Group, Open-Label, Single-Period, Phase 1 Study to Determine the Absolute Bioavailability of LY3502970 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Pharmacokinetics (PK): Absolute bioavailability of LY3502970
研究概览
简要总结
The main purpose of this study is to evaluate how much of the study drug (LY3502970) and the radioactive substance 14C incorporated LY3502970 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 for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Are overtly healthy as determined by medical evaluation
- •Participants with body weight of 45 kilograms (kg) or more and body mass index within the range 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
- •Males who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in this study
排除标准
- •Participants who have known allergies to LY3502970, related compounds, or any components of the formulation
- •Women who are lactating and women of child bearing potential (WOCBP) are excluded from the study
- •Participants who regularly use known drugs of abuse or show positive findings on drug screen
研究组 & 干预措施
LY3502970 + [14C]-LY3502970
Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970 radiolabeled with carbon-14 ([14C]-LY3502970) containing approximately 800 nanocurie (nCi) radioactivity.
干预措施: [14C]-LY3502970 (Drug)
LY3502970 + [14C]-LY3502970
Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970 radiolabeled with carbon-14 ([14C]-LY3502970) containing approximately 800 nanocurie (nCi) radioactivity.
干预措施: LY3502970 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Absolute bioavailability of LY3502970
时间窗: Predose up to 16 days postdose
PK: Absolute bioavailability of LY3502970
次要结局
- PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of Total Radioactivity(Predose up to 16 days postdose)
- PK: AUC [0-∞] of [14C]-LY3502970(Predose up to 16 days postdose)
- PK: Cmax of [14C]-LY3502970(Predose up to 16 days postdose)
- PK: Cmax of LY3502970(Predose up to 16 days postdose)
- PK: AUC [0-∞] of LY3502970(Predose up to 16 days postdose)
- PK: Maximum Concentration (Cmax) of Total Radioactivity(Predose up to 16 days postdose)