A Phase 1, Open-label Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LOXO-783 in Healthy Adult Subjects

Eli Lilly and Company1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2023年10月23日最近更新: 2024年7月22日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Eli Lilly and Company
入组人数: 16
试验地点: 1
主要终点: PK: Fraction of Dose Excreted in Expired Air (Feair)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main purpose of this study is to evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 ([¹⁴C]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and [¹⁴C]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
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: All
接受健康志愿者: 是

入选标准

•Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination, ECGs, vital signs, and clinical laboratory evaluations as assessed by the investigator
•Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
•Female participants of non-childbearing potential and male participants who follow standard contraceptive methods

排除标准

•History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
•Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
•History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator

研究组 & 干预措施

[¹⁴C]-LOXO-783 (Part 1)

Experimental

Single dose of [¹⁴C]-LOXO-783 administered orally

干预措施: [¹⁴C]-LOXO-783 (Drug)

LOXO-783 + [¹⁴C]-LOXO-783 (Part 2)

Experimental

Single dose of LOXO-783 administered orally followed by single dose of [¹⁴C]-LOXO-783 administered intravenously (IV)

干预措施: LOXO-783 (Drug)

LOXO-783 + [¹⁴C]-LOXO-783 (Part 2)

Experimental

Single dose of LOXO-783 administered orally followed by single dose of [¹⁴C]-LOXO-783 administered intravenously (IV)

干预措施: [¹⁴C]-LOXO-783 (Drug)