Comparative Pharmacokinetics and Pharmacodynamics of LY2963016 and US-Approved Lantus® After Single-Dose Subcutaneous Administration to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.
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
- •Are overtly healthy males or females
- •Have body mass index between 18.5 and 29.9 kilograms per meter square (kg/m^2)
- •Are nonsmokers and have not smoked for at least 2 months prior to entering the study
- •Have normal blood pressure and pulse rates at screening
- •Have electrocardiograms (ECGs) at screening considered as within normal limits
- •Have clinical laboratory test results within normal reference ranges
排除标准
- •Are currently enrolled in or discontinued within the last 30 days from a clinical study involving an investigational drug or device or are concurrently enrolled in any other type of medical research
- •Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin
- •Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- •Show evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases
- •Show evidence of current use of known drugs of abuse or a history of use within the past year
- •Have a history of first-degree relatives known to have diabetes mellitus
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
- •Have positive hepatitis B surface antigen at screening
- •Intend to use over-the-counter or prescription medication within 7 or 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement medication, or birth control methods)
- •Have donated or had a blood loss of 450 milliliters (mL) within 3 months prior to study enrollment
- •Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption from 24 hours prior to each dosing until discharged from the clinical research unit (CRU)
研究组 & 干预措施
LY2963016
Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study
干预措施: LY2963016 (Drug)
US-approved Lantus
Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study
干预措施: US Approved Lantus (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus
时间窗: 30 minutes predose up to 24 hours postdose in all treatment periods
The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus
时间窗: 30 minutes predose up to 24 hours postdose in all treatment periods
次要结局
- Maximum Glucose Infusion Rate (Rmax)(30 minutes predose up to 24 hours postdose in all treatment periods)
- Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure(30 minutes predose up to 24 hours postdose in all treatment periods)