An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478
研究概览
简要总结
The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions:
- How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV
- How long it takes the body to remove the study drug
- The safety of LY3039478 and any side effects that might be associated with it
Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive
排除标准
- •Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product
- •Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator
研究组 & 干预措施
LY3039478 - Oral
LY3039478 given once, orally
干预措施: LY3039478 (Drug)
13C 15N 2H-LY3039478 - IV
13C 15N 2H-LY3039478 given once, IV
干预措施: 13C 15N 2H-LY3039478 IV (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of LY3039478 and 13C 15N 2H-LY3039478
时间窗: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose
Pharmacokinetics (PK) is the area under the concentration versus time curve (AUC) from time zero to the last time point with a measurable concentration (AUC\[0-tlast\]) of LY3039478 and 13C 15N 2H-LY3039478.
PK: AUC From Zero to Infinity (AUC[0 - Inf]) of LY3039478 and 13C 15N 2H-LY3039478
时间窗: Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose
PK is AUC from zero to infinity (AUC\[0 - inf\]) of LY3039478 and 13C 15N 2H-LY3039478.
次要结局
- PK: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 and 13C 15N 2H-LY3039478(Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose)
- PK: Maximum Observed Drug Concentration (Cmax) of LY3039478 and 13C 15N 2H-LY3039478 - IV(Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose)
- PK: Time of Cmax (Tmax) of LY3039478 and 13C 15N 2H-LY3039478(Predose, 0.5, 1, 1.5, 2, 2.5, 3.5, 4, 6, 8, 12, 24, 36, 48 Hours Postdose)