Open-Label Study to Assess the Disposition of [14C]-LY3372689 Following Oral Administration 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 LY3372689 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 (LY3372689), 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 about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.
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 within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
- •Males who agree to use highly effective/effective methods of contraception for 14 weeks following the dose of LY3372689 may participate in this trial.
排除标准
- •Have a clinically significant abnormal blood pressure and/or pulse rate as determined by the investigator at screening or check-in
- •Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- •Have evidence of significant active neuropsychiatric disease, as determined by the investigator
- •Have participated in >3 radiolabeled drug studies in the last 12 months
研究组 & 干预措施
[¹⁴C]-LY3372689
Single dose of [¹⁴C]-LY3372689 administered orally.
干预措施: [¹⁴C]-LY3372689 (Drug)
结局指标
主要结局
Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
时间窗: Predose up to Day 17 post dose
Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
时间窗: Predose up to Day 17 post dose
Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
次要结局
- Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3372689(Predose up to Day 17 post dose)
- PK: Area Under the Concentration-Time Curve From Time Zero to Time (AUC (0-tlast)) of Total Radioactivity and [¹⁴C]-LY3372689(Predose up to Day 17 post dose)
- Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable)(Predose up to Day 17 post dose)
- PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹⁴C]-LY3372689(Predose up to Day 17 post dose)
- Total Number of Metabolites of LY3372689(Predose up to 120 hour post dose)