A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 and Humalog Across Different Subcutaneous Doses in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)
研究概览
简要总结
This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs are given by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 7 to 12 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
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
- •Healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
- •Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results
- •Are nonsmokers, have not smoked for at least 6 months prior to entering the study
排除标准
- •Are currently participating in or completed a clinical trial within the last 30 days
- •Have previously participated or withdrawn from this study
- •Have donated blood or have blood loss of more than 500 mL within the past 3 months
研究组 & 干预措施
LY900014
Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.
干预措施: LY900014 (Drug)
Insulin Lispro (Humalog)
Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)
时间窗: Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose \[AUC(0-10h)\]
次要结局
- Glucodynamics: Total Amount of Glucose Infused (Gtot)(Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose)