A Study to Compare LY2963016 and US-approved Lantus® After Single Dose Administration to Healthy Participants
2014年10月3日 更新者:Eli Lilly and Company
Comparative Pharmacokinetics and Pharmacodynamics of LY2963016 and US-Approved Lantus® After Single-Dose Subcutaneous Administration to Healthy Subjects
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.
研究概览
研究类型
介入性
注册 (实际的)
91
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
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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.
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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:
- 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
Exclusion Criteria:
- 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)
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 |
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实验性的:LY2963016
Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study
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皮下给药
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实验性的:US-approved Lantus
Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study
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Administered subcutaneously
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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 |
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Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus
大体时间:30 minutes predose up to 24 hours postdose in all treatment periods
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The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.
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30 minutes predose up to 24 hours postdose in all treatment periods
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Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus
大体时间:30 minutes predose up to 24 hours postdose in all treatment periods
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30 minutes predose up to 24 hours postdose in all treatment periods
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Maximum Glucose Infusion Rate (Rmax)
大体时间:30 minutes predose up to 24 hours postdose in all treatment periods
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Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and 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 US-approved Lantus by adjusting the exogenous glucose infusion rate.
Data presented were adjusted by the body weight.
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30 minutes predose up to 24 hours postdose in all treatment periods
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Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure
大体时间:30 minutes predose up to 24 hours postdose in all treatment periods
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Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure.
During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate.
Data presented were adjusted by the body weight.
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30 minutes predose up to 24 hours postdose in all treatment periods
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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9月1日
初级完成 (实际的)
2013年2月1日
研究完成 (实际的)
2013年2月1日
研究注册日期
首次提交
2012年9月17日
首先提交符合 QC 标准的
2012年9月19日
首次发布 (估计)
2012年9月20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
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
LY2963016的临床试验
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Eli Lilly and Company撤销
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Eli Lilly and Company完全的
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Eli Lilly and CompanyBoehringer Ingelheim完全的
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Eli Lilly and CompanyBoehringer Ingelheim完全的
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Eli Lilly and CompanyBoehringer Ingelheim完全的