Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel LY900014 Formulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )
研究概览
简要总结
This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered 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. Side effects and tolerability will be documented. The study will last for about 8 to 9 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
- 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)
- •Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), inclusive, at screening
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- •Are nonsmokers, 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
排除标准
- •Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- •Have previously participated or withdrawn from this study
- •Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
研究组 & 干预措施
LY900014 7.5 Units (U)
Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods.
干预措施: LY900014 (Drug)
Insulin Lispro
Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods.
干预措施: Insulin Lispro (Humalog) (Drug)
LY900014 15 U
Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods.
干预措施: LY900014 (Drug)
LY900014 30 U
Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods.
干预措施: LY900014 (Drug)
结局指标
主要结局
Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )
时间窗: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.
次要结局
- Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp(Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes)