Relative Bioavailability and the Effect of Food on the Bioavailability of LY3023414 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area under the concentration versus time curve (AUC) from time zero to infinity (AUC[0-inf]) of LY3023414
研究概览
简要总结
The purpose of this study is to measure how much LY3023414 (a test formulation and a reference formulation) gets into the blood stream and how long it takes the body to get rid of it.
The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations will be evaluated. Information about any side effects that may occur will be collected.
This study includes 3 periods. Participants will be admitted to the clinical research unit (CRU) one day before dosing in each period. Total study duration is about 21 days, including follow-up. Screening may occur up to 30 days before the first dose of study drug.
This study is for research purposes only and is not intended to treat any medical conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Healthy surgically sterile or postmenopausal females and sterile males
- •Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive at screening
排除标准
- •Cannot be investigative site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, biological or legal guardian, child, or sibling
- •Cannot be Lilly employees
- •Have known allergies to LY3023414, related compounds, or any components of the formulation
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •Show evidence of hepatitis C and/or positive hepatitis C antibody
- •Show evidence of hepatitis B and/or positive hepatitis B surface antigen
研究组 & 干预措施
LY3023414 Test Fasted
Single oral dose of LY3023414 (Test) on day one fasting.
干预措施: LY3023414 Test Fasted (Drug)
LY3023414 Reference Fasted
Single oral dose of LY3023414 (Reference) on day one fasting.
干预措施: LY3023414 Reference Fasted (Drug)
LY3023414 Test Fed
Single oral dose of LY3023414 (Test) on day one after a meal.
干预措施: LY3023414 Test Fed (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area under the concentration versus time curve (AUC) from time zero to infinity (AUC[0-inf]) of LY3023414
时间窗: Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Observed time of maximum concentration (tmax)
时间窗: Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Area under the concentration from time zero to time t, where t is the last time point with a measurable concentration (AUC [0-tlast]) of LY3023414
时间窗: Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3023414
时间窗: Pre-dose through 2 days post-dose in each period
次要结局
未报告次要终点