A Single Dose Study to Evaluate the Pharmacokinetics and Glucodynamics of Insulin Peglispro (LY2605541) in Healthy Male Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro
研究概览
简要总结
The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants are overtly healthy male Japanese.
- •Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square meter (kg/m^2), inclusive.
排除标准
- •Participants have known allergies to insulin peglispro or related compounds.
- •Participants have a fasting venous blood glucose >108 milligrams per deciliter (mg/dL) (>6 millimoles per liter [mmol/L]).
研究组 & 干预措施
Insulin Peglispro
Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.
干预措施: Insulin Peglispro (Drug)
结局指标
主要结局
Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro
时间窗: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro
时间窗: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
AUC from time zero to infinity (AUC\[0-∞\]) of insulin peglispro was evaluated.
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro
时间窗: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
Glucodynamics: Maximum Glucose Infusion Rate (Rmax)
时间窗: Predose up to 36 hours post clamp procedure
Glucodynamics: Total Amount of Glucose Infused (Gtot)
时间窗: Predose up to 36 hours post clamp procedure.
次要结局
未报告次要终点