Comparative Pharmacokinetics of LY3209590 After Administration of a Lyophilized Formulation and a Solution Formulation in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3209590
研究概览
简要总结
The main purpose of this study is to look at the amount of the study drug, LY3209590, that gets into the blood stream and how long it takes the body to get rid of LY3209590 when given as different formulations. The tolerability of LY3209590 will also be evaluated and information about any side effects experienced will be collected. The study will last up to 142 days.
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
- Double (Participant, Investigator)
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 non-pregnant females. Additionally, women of childbearing potential must test negative for pregnancy
- •Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m²), inclusive at screening
- •Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- •Have veins suitable for blood sampling
- •Have given written informed consent approved by Lilly and the ethical review board governing the site
排除标准
- •Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- •Are women who are pregnant or lactating
- •Have a history of multiple and/or severe allergic reactions
- •Show clinical evidence of HIV, hepatitis C, or hepatitis B, and/or test positive
- •Regularly use known drugs of abuse or with positive drug results
研究组 & 干预措施
LY3209590 Lyophilized Formulation
LY3209590 as lyophilized formulation administered subcutaneously (SC) in one of the two study periods.
干预措施: LY3209590 (Drug)
LY3209590 Solution Formulation
LY3209590 as solution formulation administered SC in one of the two study periods.
干预措施: LY3209590 (Drug)
结局指标
主要结局
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3209590
时间窗: Predose on Day 1 through Day 65
PK: AUC(0-inf) of LY3209590
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3209590
时间窗: Predose on Day 1 through Day 65
PK: Cmax of LY3209590
次要结局
未报告次要终点