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A Study of LY2409021 Formulations and the Effect of Food

2018年11月19日 更新者：Eli Lilly and Company

LY2409021 Formulation Bridging and Food Effect Study

The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food.

The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods.

There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

35

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

  • 新加坡
      • Singapore、新加坡
        • 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 person 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:

  • Must be healthy male or a healthy female who cannot become pregnant
  • Must have body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²), inclusive
  • Blood pressure as well as blood and urine laboratory test results must be acceptable for the study
  • The veins must be suitable for easy blood collection
  • Must be willing to be available for the whole study and be willing to follow study procedures

Exclusion Criteria:

  • Were in another new drug or medical research study in the last 30 days
  • Have previously taken part in this study or any other study with LY2409021
  • Have taken LY2409021, or drugs similar to LY2409021 before and was found to be allergic to the drug
  • Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
  • Electrocardiogram (ECG) readings are not suitable for the study
  • Are infected with hepatitis B
  • Are infected with human immunodeficiency disease virus (HIV)
  • Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study
  • Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
  • Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
  • Have a history of drug or alcohol abuse
  • Have donated 450 milliliters (mL) or more of blood in the last 3 months
  • Are unwilling or unable to comply with dietary requirements/restrictions during the study
  • The study doctor thinks the participant should not participate for any other reasons

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort 1 - LY2409021 reference form
A 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state
药品：LY2409021 Reference Form
Administered orally
实验性的：Cohort 1 - LY2409021 medium test form fed
Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal
药品：LY2409021 Test-Med Formulation (medium particle size)
Administered orally
实验性的：Cohort 1 - LY2409021 medium test form fasted
Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state
药品：LY2409021 Test-Med Formulation (medium particle size)
Administered orally
实验性的：Cohort 2 - LY2409021 low test form fasted
Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state
药品：LY2409021 Test-Low Formulation (low particle size)
Administered orally
实验性的：Cohort 2 - LY2409021 medium test form fasted
Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state
药品：LY2409021 Test-Med Formulation (medium particle size)
Administered orally
实验性的：Cohort 2 - LY2409021 high test form fasted
Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state
药品：LY2409021 Test-High Formulation (high particle size)
Administered orally

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 Concentration-Time Curve (AUC): Medium Test Form to Reference Form
大体时间：Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
AUC from time 0 to infinity (AUC0-∞).
Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form
大体时间：Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)

次要结果测量

结果测量
措施说明
大体时间
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting
大体时间：Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
AUC from time 0 to infinity (AUC0-∞).
Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting
大体时间：Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Time to Maximum Concentration (Tmax)
大体时间：Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size
大体时间：Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
AUC from time 0 to infinity (AUC0-∞).
Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size
大体时间：Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)

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。

赞助

Eli Lilly and Company

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)

2011年10月1日

研究完成 (实际的)

2011年10月1日

研究注册日期

首次提交

2011年5月13日

首先提交符合 QC 标准的

2011年5月13日

首次发布 (估计)

2011年5月17日

研究记录更新

最后更新发布 (实际的)

2019年3月11日

上次提交的符合 QC 标准的更新

2018年11月19日

最后验证

2018年11月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 14194
  • I1R-FW-GLBQ (其他标识符：Eli Lilly and Company)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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