Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞])
研究概览
简要总结
The purposes of this study are to determine:
-
Part A
-
How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation.
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The safety of insulin lispro in different formulations and any side effects that might be associated with it.
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Part B:
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How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A).
-
The safety of insulin lispro in different formulations and any side effects that might be associated with it.
Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.
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
- 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 males or females (non-childbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination
排除标准
- •- Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening
研究组 & 干预措施
Part A: Lispro (A)
Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods.
干预措施: Lispro (Drug)
Part A: Lispro (B)
Formulation B: Single dose of lispro administered SC in one of five periods.
干预措施: Lispro (Drug)
Part A: Lispro (C)
Formulation C: Single dose of lispro administered SC in one of five periods.
干预措施: Lispro (Drug)
Part A: Lispro (D)
Formulation D: Single dose of lispro administered SC in one of five periods.
干预措施: Lispro (Drug)
Part A: Lispro (Reference)
Reference formulation: Single dose of lispro administered SC in one of five periods.
干预措施: Lispro (Drug)
Part B: Lispro
Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.
干预措施: Lispro (Drug)
结局指标
主要结局
Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞])
时间窗: -30, 0 (Predose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, and 300 Minutes
Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration.
次要结局
未报告次要终点