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A Relative Bioavailability and Food Effect Study of New Formulations

2017年3月10日 更新者:Eli Lilly and Company

Relative Bioavailability of the LY3009104 Free Base Test Formulation Compared to the Reference Phosphate Salt Formulation and the Effect of Food on the Bioavailability of the Test Formulation in Healthy Subjects

The purpose of this trial is to assess the effect of 3 formulations on the relative bioavailability of LY3009104. Participants will receive single dose of LY3009104 on 4 separate occasions with and without food. Safety evaluation and serial pharmacokinetic (PK) samples will be collected during each treatment period. Approximately 5 to 7 days of washout period between each treatment and a follow-up visit will occur approximately 5 to 7 days after the last dose of study drug.

研究概览

研究类型

介入性

注册 (实际的)

15

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:

  • Overtly healthy males or females as determined by medical history and physical examination
  • Have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2), inclusive, at screening
  • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
  • Have normal blood pressure and pulse rate as determined by the investigator
  • Have venous access sufficient to allow for blood sampling
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
  • Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

Male Participants:

  • Agree to use two forms of highly effective methods of birth control [oral, injectable, or implanted hormonal contraceptives; condom with spermicidal foam/gel/film/cream/suppository; occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; intrauterine device; intrauterine system, for example, progestin releasing coil; and vasectomised male (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate)] with female partners of childbearing potential during the study and for at least 3 months following the last dose of study drug

Female participants:

  • Are women of non-childbearing potential, defined as: women with Mayer Rokitansky Kuster Hauser Syndrome (also referred to as Clinical Absence of Uterus and Vagina), or women who have had surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation), or women greater than 60 years of age, or women greater than 40 and less than 60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential [FSH ≥40 milli-international units per milliliter (mIU/mL)]

Exclusion Criteria:

  • Are currently enrolled in, or 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
  • Have a history of adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose)
  • Are participants who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY3009104
  • 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
  • Current or recent history (<30 days prior to screening and/or <45 days prior to Check-in) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
  • Have an absolute neutrophil count (ANC) less than 2000 cells per microliter (cell/μL). For abnormal values, a single repeat will be allowed
  • Have a 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
  • Regularly use known drugs of abuse
  • Have had symptomatic herpes zoster or herpes simplex infection within 90 days prior to the first dose
  • Have been exposed to a live vaccine within 12 weeks prior to the first dose or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Intend to use over-the-counter or prescription medication and herbal supplements within 14 days prior to dosing and during the study
  • Intend to use vitamins and mineral supplements within 2 days prior to dosing and during the study
  • Have donated blood of more than 450 milliliters (mL) within the previous 3 months
  • Have consumed grapefruit, starfruit, pomelos, or products containing these fruits, 7 days prior to the first dose and during the study
  • 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 for 48 hours prior to admission in each period until the 48 hour PK sample has been collected [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
  • Have used any tobacco-containing or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to enrollment

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:治疗
  • 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:LY3009104 Reference Formulation
8 milligrams (mg) LY3009104 (two 4-mg phosphate salt capsules), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug.
口服给药
实验性的:LY3009104 Test Formulation 1
8 mg LY3009104 (one 8-mg smaller particle free base tablet), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug.
口服给药
实验性的:LY3009104 Test Formulation 2
8 mg LY3009104 (one 8-mg larger particle free base tablet), administered orally in the fasted state, once only. There will be a washout period of 5 to 7 days between doses of study drug.
口服给药
实验性的:LY3009104 Test Formulation 2 + Meal
8 mg LY3009104 (one 8-mg larger particle free base tablet), administered orally with high-fat/high calorie meal, once only. There will be a washout period of 5 to 7 days between doses of study drug.
口服给药

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: Plasma Concentration-Time Curve (AUC)
大体时间:Predose up to 48 hours postdose for each of the 4 treatment periods
The area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] is reported for participants who received either LY3009104 tablets or capsules in a fasted or fed state.
Predose up to 48 hours postdose for each of the 4 treatment periods

次要结果测量

结果测量
大体时间
Pharmacokinetics: Maximum Plasma Concentration (Cmax)
大体时间:Predose up to 48 hours postdose for each of the 4 treatment periods
Predose up to 48 hours postdose for each of the 4 treatment periods
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax)
大体时间:Predose up to 48 hours postdose for each of the 4 treatment periods
Predose up to 48 hours postdose for each of the 4 treatment periods

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7月1日

初级完成 (实际的)

2011年9月1日

研究完成 (实际的)

2011年9月1日

研究注册日期

首次提交

2011年7月19日

首先提交符合 QC 标准的

2011年7月19日

首次发布 (估计)

2011年7月20日

研究记录更新

最后更新发布 (实际的)

2017年4月21日

上次提交的符合 QC 标准的更新

2017年3月10日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 14016 (company internal)
  • I4V-MC-JADH (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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