A Phase 1 Study to Evaluate the Pharmacokinetics of LY2605541 Injection and Insulin Lispro Injection Administered as Mixture or as Individual Components in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro
研究概览
简要总结
The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, not including screening. Screening is required within 28 days prior to the start of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Are not of child-bearing potential
- •Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m^2), inclusive
- •Are nonsmokers or have not smoked for at least 2 months prior to entering the study
排除标准
- •Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin
- •Have a history of first-degree relatives known to have diabetes mellitus
- •Have used systemic glucocorticoids within 3 months prior to entry into the study
- •Have donated blood or had a blood loss of 450 milliliter (mL) within 1 month prior to study enrollment
研究组 & 干预措施
LY2605541-Part A
1.42 units per kilogram (U/kg) of LY2605541 given once daily (QD) for 1 day, subcutaneously (SQ) in 1 of 4 treatment periods.
干预措施: LY2605541 (Drug)
Insulin Lispro-Part A
Single dose 0.36 U/kg of insulin lispro given QD for 1 day, SQ in 1 of 4 treatment periods.
干预措施: Insulin Lispro (Drug)
LY2605541/Lispro Mix 1-Part A
Single dose 0.54 U/kg of LY2605541 and 0.36 U/kg insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.
干预措施: LY2605541 (Drug)
LY2605541/Lispro Mix 1-Part A
Single dose 0.54 U/kg of LY2605541 and 0.36 U/kg insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.
干预措施: Insulin Lispro (Drug)
LY2605541/Lispro Mix 2-Part A
Single dose 1.42 U/kg of LY2605541 and 0.36 insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.
干预措施: LY2605541 (Drug)
LY2605541/Lispro Mix 2-Part A
Single dose 1.42 U/kg of LY2605541 and 0.36 insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.
干预措施: Insulin Lispro (Drug)
Insulin Lispro-Part B
0.18 U/kg insulin lispro given twice daily (BID) for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
干预措施: Insulin Lispro (Drug)
LY2605541/Lispro Mix-Part B
0.71 U/kg LY2605541 and 0.18 U/kg insulin lispro mixture given BID for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
干预措施: LY2605541 (Drug)
LY2605541/Lispro Mix-Part B
0.71 U/kg LY2605541 and 0.18 U/kg insulin lispro mixture given BID for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
干预措施: Insulin Lispro (Drug)
LY2605541 QD-Part B
0.54 U/kg of LY2605541 given QD for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
干预措施: LY2605541 (Drug)
LY2605541 BID-Part B
0.71 U/kg of LY2605541 given BID for 1 day SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
干预措施: LY2605541 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro
时间窗: Pre-dose up to 216 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-∞) of LY2605541 and Insulin Lispro
时间窗: Pre-dose up to 216 hours post-dose
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Lispro
时间窗: Pre-dose up to 216 hours post-dose
次要结局
- Maximum Glucose Infusion Rate (Rmax)(Predose up to 32 hours post clamp procedure in all treatment periods)
- Total Glucose Infused Over Clamp Duration (Gtot)(Predose up to 32 hours post clamp procedure in all treatment periods)