NCT01746004已完成1 期
Disposition of [14C]-LY2157299 Monohydrate Following Oral Administration in Healthy Subjects
适应症
干预措施
相关药物
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 and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
研究概览
简要总结
This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate in healthy participants. The study will determine how the body eliminates the radioactivity and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal females, or sterile males. This study is approximately 8 to 15 days.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy surgically sterile females, postmenopausal females, or sterile males
- •Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2)
- •Have venous access sufficient to allow for blood sampling
排除标准
- •Have known allergies to LY2157299, related compounds or any components of the formulation
- •Have an abnormal blood pressure as determined by the investigator
- •Have participated in a [^14C]-study within the last 6 months prior to admission for this study
研究组 & 干预措施
[^14C]-LY2157299
Experimental
Single 150 mg oral dose of LY2157299 monohydrate containing 100 micro curies of [^14C] labeled drug
干预措施: [^14C]-LY2157299 (Drug)
结局指标
主要结局
Urinary and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
时间窗: Pre-dose through Day 15
次要结局
- Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax)(Pre-dose through Day 14)
- Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax)(Pre-dose through Day 14)
- Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Area Under the Concentration-Time Curve from Time Zero to the Last Timepoint with a Measurable Concentration (AUC 0 to tlast)(Pre-dose through Day 14)
- Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces(Pre-dose through Day 14)
- Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma(Pre-dose through Day 14)
研究者
研究点 (1)
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