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A Study Designed to See How [14C]-CORT125134 is Taken up, Broken Down and Removed From the Body

2019年8月7日 更新者:Corcept Therapeutics

An Open-label, Single-dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-CORT125134 in Healthy Subjects

The study was designed to evaluate how CORT125134 is taken up, broken down and removed from the body when given as an oral capsule to healthy subjects.

研究概览

地位

完全的

条件

详细说明

The study was conducted to determine the recovery of [14C]-CORT125134 after the administration of a single oral dose of [14C]-CORT125134, to determine the routes and rate of elimination of [14C]-CORT125134 and associated radioactivity from the body, and to measure concentrations of radioactivity in the blood. Additional objectives of the study were to determine the chemical structure of each significant metabolite in plasma, urine and feces. Safety and tolerability were assessed.

研究类型

介入性

注册 (实际的)

9

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

    • Nottinghamshire
      • Nottingham、Nottinghamshire、英国、NG11 6JS
        • Quotient Clinical

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

30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 healthy females of non-childbearing potential (surgically sterilized or postmenopausal [defined as a woman of with at least a 12 month history of amenorrhea with a follicle-stimulating hormone (FSH) >40 international units per liter (IU/L) in the absence of a reversible medical iatrogenic cause])
  • Age 30 to 65 years of age
  • A history of regular bowel movements (averaging ≥1 and ≤3 stools per day)
  • Must be willing and able to communicate and participate in the whole study
  • Must provide written informed consent
  • Male participants must agree to use an adequate method of contraception
  • Participants are willing to abide by the study restrictions

Exclusion Criteria:

  • Participation in a clinical research study within the previous 3 months
  • Participants who have previously been enrolled in this study or participants who have previously been treated with CORT125134
  • History of any drug or alcohol abuse in the past 2 years
  • Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 milliliter (mL) of 40% spirit or a 125 mL glass of wine)
  • Current smokers and those who have smoked within the last 12 months; this includes cigarettes, e-cigarettes and nicotine replacement products. A breath carbon monoxide reading of greater than 10 parts per million (ppm)
  • Females of childbearing potential (female participants must have a negative urine pregnancy test)
  • Male Participants with pregnant partners
  • Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. The measurement includes exposure from the present study, and diagnostic x rays and other medical exposures, but excludes background radiation. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999.
  • Positive drugs of abuse test result
  • Participants who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 grams per day paracetamol) or herbal remedies in the 14 days before study drug administration. Hormone replacement therapy is not permitted

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:不适用
  • 介入模型:单组作业
  • 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:[14C]-CORT125134
Two capsules each containing 125 milligrams (mg) [14C]-CORT125134 administered to each participant on 1 occasion

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Amount of radioactivity eliminated in urine
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in feces
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in urine and feces
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in urine
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in feces
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in urine and feces
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Pharmacokinetics (PK) of total radioactivity: lag time (tlag)
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: peak plasma concentration (Cmax)
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: time to reach maximum observed concentration (tmax)
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: area under the plasma concentration-time curve from time zero to infinity (AUCinf)
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCextrap)
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve (lambda-z)
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: elimination half-life (t1/2)
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Metabolic profiling and structural identification in plasma, urine and feces
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose

次要结果测量

结果测量
大体时间
Hematology
大体时间:Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Clinical chemistry
大体时间:Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Urinalysis
大体时间:Screening, Day 1 pre-dose, Day 8
Screening, Day 1 pre-dose, Day 8
Blood pressure
大体时间:Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Heart rate
大体时间:Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Electrocardiogram
大体时间:Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Screening, Day 1 pre-dose and 2 hours post-dose, Day 8
Percentage of subjects with adverse events
大体时间:Screening to Day 28
Screening to Day 28
Physical examination
大体时间:Screening and Day 8
Screening and Day 8
Tlag of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Cmax of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Tmax of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
AUClast of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
%AUCextrap of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
AUCinf of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Lambda-z of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
T1/2 of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Mean Residence Time (MRT) of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Apparent oral clearance (CL/F) of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Apparent volume of distribution (Vz/F) of CORT125134
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of circulating radioactivity in plasma
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of the dose in urine
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of the dose in feces
大体时间:Day 1 pre-dose to Day 8 post-dose
Day 1 pre-dose to Day 8 post-dose

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。

调查人员

  • 首席研究员:Pui Leung, MBChB、Quotient Clinical

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

2016年8月1日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2016年9月1日

研究注册日期

首次提交

2016年12月6日

首先提交符合 QC 标准的

2017年2月23日

首次发布 (实际的)

2017年3月1日

研究记录更新

最后更新发布 (实际的)

2019年8月9日

上次提交的符合 QC 标准的更新

2019年8月7日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • CORT125134-121
  • 2016-000668-41 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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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