A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Following Single Dose Administration in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])
研究概览
简要总结
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and the effect of LY900014 on blood sugar levels. For each participant, the study will consist of 3 periods and will last about 51 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
- Single (Participant)
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 native Chinese males or females
- •Female participants:
- •Women of child-bearing potential who are abstinent or use effective methods of contraception for the entirety of the study.
- •Women not of child-bearing potential who are infertile or post-menopausal
- •Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²)
- •Are nonsmokers
- •Have a fasting plasma glucose value >71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L)
排除标准
- •Are currently enrolled in a clinical study, or have participated, within the last 30 days, in a clinical study involving an investigational product
- •Have previously completed or withdrawn from this study or any other study investigating LY900014
- •Have known allergies to LY900014 or any components of the formulation
- •Have a significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- •Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, prior to dosing or during the study.
- •Have donated blood of more than 400 milliliters (mL) within the previous 6 months of study screening or donated more than 100 mL within the last 30 days.
- •Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
研究组 & 干预措施
Insulin Lispro (Humalog)
15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods.
干预措施: Insulin Lispro (Drug)
LY900014
7 U, and 15 U LY900014 administered once, SC, in two of three study periods.
干预措施: LY900014 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])
时间窗: Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose
PK: Insulin Lispro AUC(0-10h)
次要结局
- Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)(Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose)