An Absolute Bioavailability Study of LY3314814 in Healthy Subjects Using an Intravenous Tracer Method
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Absolute Bioavailability of LY3314814
研究概览
简要总结
The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The study will last at least two weeks for each participant, not including screening.
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
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are overtly healthy males or females
- •Have venous access sufficient to allow for blood sampling and intravenous (IV) administration of the investigational product
排除标准
- •Have a history of significant ophthalmic disease
- •Have vitiligo or any other clinically significant disorder of skin pigmentation
- •Have a history of use of antipsychotic drugs, or chronic use of antidepressant or anxiolytic drugs, prescribed as well as non-prescribed
研究组 & 干预措施
LY3314814
Single 50 milligram (mg) dose of LY3314814 administered orally
干预措施: LY3314814 (Drug)
[13C415N3] LY3314814
Single 100 micrograms (μg) intravenous (IV) dose of [13C415N3] LY3314814 administered as an IV infusion.
干预措施: [13C415N3] LY3314814 (Drug)
结局指标
主要结局
Absolute Bioavailability of LY3314814
时间窗: Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose
Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered \[13C415N3\]-LY3314814.
次要结局
- Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814(Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose)