Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Multiple LY900014 Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro
研究概览
简要总结
This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.
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
- Single (Participant)
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
- •Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
- •Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- •Are non-smokers or have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study
- •Have veins suitable for easy blood collection and glucose solution infusion
排除标准
- •Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug
- •Show signs of having an infection or infectious disease at the time of study entry
研究组 & 干预措施
Insulin Lispro
Reference formulation: Single dose of lispro administered SC in one of five periods
干预措施: Insulin lispro (Humalog) (Drug)
LY900014 Test B
Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
干预措施: LY900014 (Drug)
LY900014 Test A
Test formulation B: Single dose of LY900014 formulation administered SC in one of five periods
干预措施: LY900014 (Drug)
LY900014 Test C
Test formulation C: Single dose of LY900014 formulation administered SC in one of five periods
干预措施: LY900014 (Drug)
LY900014 Test D
Formulation D: Single dose of LY900014 formulation administered SC in one of five periods
干预措施: LY900014 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro
时间窗: Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose
次要结局
- Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp(Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes.)