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A Study of LY2963016 in Healthy Participants

2014年10月3日 更新者:Eli Lilly and Company

Pharmacokinetics and Pharmacodynamics of LY2963016 Compared to Lantus® in Healthy Subjects Following Two Single Subcutaneous Doses

This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There will be at least 6 days between each injection.

The study will compare LY2963016 to Lantus at two different doses.

This study is approximately 10 weeks long, not including screening. Screening is required within 4 weeks of the start of the study.

研究概览

地位

完全的

研究类型

介入性

注册 (实际的)

24

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Singapore、新加坡、117597
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy males or females
  • Women must be either surgically sterile, post-menopausal, or agree to use a reliable method of birth control during the study
  • Have a body mass index between 18.5 and 29.9 kilograms per meter squared (kg/m²)
  • Are nonsmokers and have not smoked for at least 6 months prior to entering the study
  • Have normal blood pressures and pulse rates at screening, as determined by the investigator
  • Have an electrocardiogram (ECG) at screening considered as within normal limits by the investigator
  • Have clinical laboratory test results within normal reference range for the population
  • Have fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6.0 micromoles per liter [mmol/L]) at screening
  • Have venous access sufficient to allow for blood sampling, intravenous drug administration, and clamp procedures as per the protocol
  • Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

Exclusion Criteria:

  • Are persons who have previously completed or withdrawn from this study
  • Are currently enrolled in or have discontinued within the last 30 days from a clinical trial involving an investigational drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • 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 capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Show evidence of significant active neuropsychiatric disease
  • Show evidence of current use of known drugs of abuse or have a history of use within the past year
  • Have a history of first-degree relatives known to have diabetes mellitus
  • Show evidence of an acute infection with fever or infectious disease at the time of study entry
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
  • Have positive hepatitis B surface antigens at screening
  • Intend to use over-the-counter medication within 7 days or prescription medication within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement, or birth control methods)
  • Have donated blood or had a blood loss of 450 milliliters (mL) 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 48 hours prior to each dosing until discharged from the clinical research unit (CRU)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:0.3 U/kg LY2963016
Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016
皮下给药
实验性的:0.3 U/kg Lantus
Single 0.3 U/kg subcutaneous dose of Lantus
皮下给药
实验性的:0.6 U/kg LY2963016
Single 0.6 U/kg subcutaneous dose of LY2963016
皮下给药
实验性的:0.6 U/kg Lantus
Single 0.6 U/kg subcutaneous dose of Lantus
皮下给药

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]
大体时间:Predose up to 24 hours after administration of study drug
Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.
Predose up to 24 hours after administration of study drug
Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)
大体时间:Predose up to 24 hours after administration of study drug
Predose up to 24 hours after administration of study drug

次要结果测量

结果测量
措施说明
大体时间
Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus
大体时间:Predose up to 24 hours after administration of study drug
Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.
Predose up to 24 hours after administration of study drug
Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus
大体时间:Predose up to 24 hours after administration of study drug
Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.
Predose up to 24 hours after administration of study drug
Maximum Glucose Infusion Rate (Rmax)
大体时间:Postdose up to 24 hours after administration of study drug
Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
Postdose up to 24 hours after administration of study drug
Total Amount of Glucose Infused (Gtot)
大体时间:Postdose up to 24 hours after administration of study drug
Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
Postdose up to 24 hours after administration of study drug

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年7月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2012年7月2日

首先提交符合 QC 标准的

2012年7月2日

首次发布 (估计)

2012年7月6日

研究记录更新

最后更新发布 (估计)

2014年10月7日

上次提交的符合 QC 标准的更新

2014年10月3日

最后验证

2014年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 14676
  • I4L-MC-ABEM (其他标识符:Eli Lilly and Company)

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