Effect of Injection Site on the Relative Bioavailability of Single Dose of LY3209590 and Evaluation of Absolute Bioavailability of LY3209590 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590
研究概览
简要总结
The study will be conducted in two parts (part A and part B). The main purpose of this study is to compare the amount of LY3209590 that gets into the blood stream and how long it takes the body to get rid of it, when self-administered at different body sites, abdominal wall, upper arm and thigh (part A), when administered by two different routes of injection, subcutaneously or intravenously (part B) in healthy participants.
The study may last up to 65 (part A) and 184 (part B) days, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants who are overtly healthy as determined by medical evaluation
- •Participants with body mass index (BMI) within the range 18.5 to 35.0 kilograms per meter squared (kg/m²)
- •Male or female participants must agree to use contraception
排除标准
- •Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
- •Have known allergies to LY3209590, related compounds, or any components of the formulation
- •Have an abnormality in the 12-lead electrocardiogram
- •Intend to use prescription medication, including herbal medications and traditional medications
- •Show evidence of human immunodeficiency virus infection or positive human immunodeficiency virus antibodies, hepatitis C or positive hepatitis C antibody, or hepatitis B or positive hepatitis B surface antigen
- •Are lactating or pregnant
研究组 & 干预措施
LY3209590 (Part A - Upper Arm)
LY3209590 administered subcutaneously (SC) into the upper arm
干预措施: LY3209590 (SC) (Drug)
LY3209590 (Part A - Thigh)
LY3209590 administered SC into the thigh
干预措施: LY3209590 (SC) (Drug)
LY3209590 (Part A - Abdominal Wall)
LY3209590 administered SC into the abdominal wall
干预措施: LY3209590 (SC) (Drug)
LY3209590 (Part B - IV Dose)
LY3209590 administered intravenously (IV)
干预措施: LY3209590 (IV) (Drug)
LY3209590 (Part B - SC Dose)
LY3209590 administered SC into the abdominal wall
干预措施: LY3209590 (SC) (Drug)
结局指标
主要结局
Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590
时间窗: Predose on Day 1 through Day 65
Part A: PK: AUC0-∞ of LY3209590
次要结局
- Part B: PK: AUC0-∞ of LY3209590(Predose on Day 1 through Day 65)