A Single-Group, Open-Label, Single-Period, Phase 1 Study to Determine the Absolute Bioavailability of LY3502970 in Healthy Participants

Eli Lilly and Company1 个研究点分布在 1 个国家目标入组 10 人2023年10月19日

适应症Healthy

干预措施LY3502970 [14C]-LY3502970

概览

阶段: 1 期
干预措施: LY3502970
疾病 / 适应症: Healthy
发起方: Eli Lilly and Company
入组人数: 10
试验地点: 1
主要终点: Pharmacokinetics (PK): Absolute bioavailability of LY3502970
状态: 已完成
最后更新: 2年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2023年10月19日

结束日期

2024年1月5日

最后更新

2年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Eli Lilly and Company

责任方

Sponsor

入排标准

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

Single dose of LY3502970 administered orally followed by single dose of \[¹⁴C\]-LY3502970 administered intravenously (IV)

干预措施: LY3502970

LY3502970 + [14C]-LY3502970

Single dose of LY3502970 administered orally followed by single dose of \[¹⁴C\]-LY3502970 administered intravenously (IV)

干预措施: [14C]-LY3502970

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)