An Absolute Bioavailability Study of LY2835219 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
- 11
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219
研究概览
简要总结
The aim of this study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and as an intravenous infusion (given directly into a vein via a small needle).
The study will also provide information on how well the study drug is tolerated when given as a capsule in combination with giving it intravenously, and information on any changes in heart function.
The study will last about 10 days. Screening is required within 28 days before study drug is given.
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
- •Overtly healthy sterile males or surgically sterile females or postmenopausal females
- •Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)
- •Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
- •Participants who are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
排除标准
- •Have participated in a clinical trial involving investigational product within the last 90 days
- •Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Have an abnormal blood pressure
- •Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- •Have donated blood of more than 500 milliliters (mL) within the last month
- •Have consumed any sensitive CYP2B6 substrate drugs, any CYP3A4 inhibitor or any CYP3A inducer, herbal supplements, grapefruits or grapefruit containing products, Seville oranges or Seville orange containing products, star fruits or star fruit containing products within 2 weeks prior to dosing or intend to consume during the study
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
研究组 & 干预措施
200 mg LY2835219
200 mg LY2835219 administered orally on day 1.
干预措施: LY2835219 (Drug)
0.4 mg ¹³C₈-LY2835219
0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose.
干预措施: ¹³C₈-LY2835219 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219
时间窗: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
次要结局
- PK: Maximum Observed Concentration (Cmax) of LY2835219(Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose)
- PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219(Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose)