Disposition of [14C]-LY3214996 Following Oral Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Urinary Excretion of LY3214996 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 measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Overtly health males
- •Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
排除标准
- •Male participants sexually active with a pregnant partner
- •Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study
- •Have participated in a radiolabeled drug study within the previous 4 months
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- •Have a history of Gilbert's syndrome
- •Have history or presence of psychiatric disorders
- •Show evidence of human immunodeficiency virus (HIV) infection
- •Show evidence of hepatitis C
- •Show evidence of hepatitis B
研究组 & 干预措施
LY3214996 + [14C]-LY3214996
A single dose of LY3214996 and [14C]-LY3214996 administered orally.
干预措施: LY3214996 (Drug)
LY3214996 + [14C]-LY3214996
A single dose of LY3214996 and [14C]-LY3214996 administered orally.
干预措施: [14C]-LY3214996 (Drug)
结局指标
主要结局
Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
时间窗: Baseline through Day 8 after administration of study drug
Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
时间窗: Baseline through Day 8 after administration of study drug
Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996(Predose through Day 8 after administration of study drug)
- PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996(Predose through Day 8 after administration of study drug)
- Total Number of Metabolites of LY3214996(Baseline through 48 hours after administration of study drug)