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A Study of LY2951742 in Healthy Volunteers

2018年10月8日 更新者:Eli Lilly and Company

A Safety, Tolerability, and Pharmacokinetic Study of Single, Escalating Subcutaneous Doses of LY2951742 in Healthy Volunteers

To evaluate the safety and tolerability of LY2951742 given as single or multiple subcutaneous injection in healthy male subjects

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

63

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

      • Leuven、比利时
        • 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

18年 至 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Are healthy Caucasian males, as determined by medical history and physical examination
  • Agree to use a reliable method of birth control (e.g. condom AND additional contraception method to be used by respective partner) during the study and for 3 months following the last dose of the investigational product
  • Have a body mass index (BMI) greater than 19 kilogram/square meter (kg/m^2)
  • Have clinical laboratory test results within normal reference range for the population or investigator site
  • Have venous access sufficient to allow for blood sampling
  • Are willing to follow study procedures including no drugs (exception of study drug) 72 hours prior to initiation of the laser doppler imaging (LDI) procedure, no chocolate, alcohol or caffeine containing products 12 hours prior to initiation of the laser doppler imaging (LDI) procedure, and complete a 4 hour fast prior to initiation of the laser doppler imaging (LDI) procedure
  • Have suitable skin characteristics for the dermal capsaicin challenge and have demonstrated a 100 percent increase in dermal flow following capsaicin challenge as part of the screening procedures and measured by laser doppler imaging (LDI)

Exclusion Criteria:

  • Are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study investigating LY2951742
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study including QTc greater than 450 milliseconds (msec) (male), history of congenital long QT syndrome or other conduction abnormality
  • Have abnormal vital signs as determined by the investigator
  • Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders (including migraine) that would constitute a risk when taking the study medication; or of interfering with the interpretation of data study
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Show evidence of:

    1. Human immunodeficiency virus infection and/or positive human immunodeficiency virus (HIV) antibodies
    2. Hepatitis C and/or positive hepatitis C antibody
    3. Hepatitis B and/or positive hepatitis B surface antigen
  • Intend to use over-the-counter or prescription medication that may interfere with study safety assessments or other measurements within 7 days prior to dosing and during the study (example: systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal reactions, and drugs with known liver toxicity).
  • Have donated blood of more than 500 milliliter (mL) or has undergone major surgery
  • The use of caffeine containing products and alcohol is not allowed from 12 hours prior to all study visits and during in clinic stays. All other times, alcohol consumption and caffeine intake are limited to no more than 2 alcoholic beverages or equivalent (beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits (25 milliliter [mL/1 ounce]) per day and caffeinated beverages will be limited to no more than 2 units per day amounts (1 unit=120 milligrams [mg] of caffeine). Strenuous activity is not allowed from 1 week prior to admission until the follow-up visit.
  • Are smokers within the previous 6 months
  • Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer)prior to dosing or have received a vaccination within 1 month
  • Have a history of multiple or severe allergies or has had an anaphylactic reaction or intolerability to prescription or non-prescription drugs or food
  • Are immunocompromised
  • Have had cancer or within the past 5 years
  • Have a history of significant allergies, in particular to ethanol or sensitivity to the fruits of capsicum plants (example: chili peppers)
  • Have eczema, scleroderma, psoriasis, dermatitis, keloids, tumors, ulcers, burns, flaps, or grafts on their forearm or other abnormality of the skin which may interfere with the study assessments
  • Cannot avoid excess tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover forearms for 24 hours prior to treatment period
  • Have excessive hair growth on the volar surface of the forearm or subjects currently using lotions, oils, depilatory preparations, or other topical treatments on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study

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:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Single dose 1 milligram (mg) LY2951742
Administered single subcutaneous injection
Administered subcutaneously
实验性的:Single dose 5 mg LY2951742
Administered single subcutaneous injection
Administered subcutaneously
实验性的:Single dose 25 mg LY2951742
Administered single subcutaneous injection
Administered subcutaneously
实验性的:Single dose 75 mg LY2951742
Administered single subcutaneous injection
Administered subcutaneously
实验性的:Single dose 200 mg LY2951742
Administered single subcutaneous injection
Administered subcutaneously
实验性的:Single dose 600 mg LY2951742
Administered single subcutaneous injection
Administered subcutaneously
安慰剂比较:Single dose placebo
Administered single subcutaneous injection
皮下给药
安慰剂比较:Multiple dose placebo
Administered subcutaneously every 2 weeks for 6 weeks (4 doses)
皮下给药
实验性的:150 mg LY2951742
Administered subcutaneously every 2 weeks for 6 weeks (4 doses)
Administered subcutaneously

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
Number of Participants With Clinically Significant Effects
大体时间:Baseline up to 6 months (study completion)
Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.
Baseline up to 6 months (study completion)

次要结果测量

结果测量
大体时间
Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
大体时间:Day 1 up to Day 84 or early discontinuation
Day 1 up to Day 84 or early discontinuation
Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
大体时间:Day 1 up to Day 84 or early discontinuation
Day 1 up to Day 84 or early discontinuation
Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)
大体时间:Day 43 up to Day 57
Day 43 up to Day 57
Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)
大体时间:Day 43 up to Day 57
Day 43 up to Day 57

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

2011年4月1日

初级完成 (实际的)

2012年4月1日

研究完成 (实际的)

2012年4月1日

研究注册日期

首次提交

2011年4月15日

首先提交符合 QC 标准的

2011年4月15日

首次发布 (估计)

2011年4月19日

研究记录更新

最后更新发布 (实际的)

2019年2月20日

上次提交的符合 QC 标准的更新

2018年10月8日

最后验证

2012年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 14248
  • I5Q-MC-CGAA (其他标识符:Eli Lilly and Company)

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.

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