Effects of CYP3A Induction by Rifampin on the Pharmacokinetics of LY2835219 and Its Metabolites in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219
研究概览
简要总结
The aim of this two-period 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 when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other infections). Each participant will complete both study periods.
The study will last about 34 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 —（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)
排除标准
- •Have participated in a clinical trial involving investigational product within the last 30 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 used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study
研究组 & 干预措施
LY2835219
Single oral dose of LY2835219
干预措施: LY2835219 (Drug)
LY2835219 + Rifampin
Single oral dose of LY2835219 with rifampin orally, once daily for 14 days
干预措施: LY2835219 (Drug)
LY2835219 + Rifampin
Single oral dose of LY2835219 with rifampin orally, once daily for 14 days
干预措施: Rifampin (Drug)
结局指标
主要结局
PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219
时间窗: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219
时间窗: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
次要结局
未报告次要终点