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A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants

2019年5月31日 更新者:Millennium Pharmaceuticals, Inc.

A Phase 1, Open-label, Single Intravenous Infusion Dose Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Adult Male Subjects

The purpose of this study is to determine the mass balance, routes of elimination and characterize the metabolic profiles of a single intravenous dose of [14C]-TAK-954, identify major circulating and excreted metabolites. This study will also determine the single-dose PK of total radioactivity, TAK-954 and its metabolites where possible.

研究概览

地位

完全的

详细说明

The drug being tested in this study is called TAK-954. This study will assess the mass balance, metabolic profiles and routes of elimination of single intravenous dose of [14C]-TAK-954, and will determine the major circulating and excreted metabolites and single-dose PK of total radioactivity, TAK-954, THRX513466, and THRX 913682 in healthy male participants.

The study will enroll approximately 6 participants. All participants will receive a single dose of [14C]-TAK-954 0.5 mg on Day 1.

This single-center trial will be conducted in Netherlands. The overall time to participate in this study is approximately 6 to 7 weeks. Participants will make a final visit to the clinic 15 days after last dose of study drug for a follow-up assessment.

研究类型

介入性

注册 (实际的)

6

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

      • Groningen、荷兰、9728 NZ
        • PRAHS

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:

  1. Be a man aged 18 to 55 years, inclusive, at the screening visit.
  2. Have a body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 30 kilogram per square meter (kg/m^2) and a body weight greater than (>) 50 kilogram (kg) at the screening visit.
  3. Be a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug.
  4. Meet the following birth control requirements:

    • Is a male participant who is sterile or agrees to use an appropriate method of contraception, including a condom, from the first dose of study drug until 30 days after the last dose of study drug. No restrictions are required for a vasectomized male participant provided that the participant is at least 1 year postbilateral vasectomy procedure before the first dose of study drug. A male participant whose vasectomy procedure was performed less than 1 year before the first dose of study drug must follow the same restrictions as a nonvasectomized man. Appropriate documentation of surgical procedures should be provided.
    • Is a male participant who agrees to not donate sperm from trial drug administration on the first day of the first dose until 30 days after the last dose of study drug.

Exclusion Criteria:

  1. Has total 14C radioactivity measured by accelerator mass spectrometry in plasma (during screening) exceeding 14C/12C ratio 1.1E-12.
  2. Participated in any study with a radiation dose above 0.1 millibecquerel (MBq) or radiation burden above 0.1 millisievert (mSv) within 1 year before screening.
  3. Was exposed to significant radiation (example, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months before check-in.
  4. Irregular defecation pattern (less than once per 2 days).
  5. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to beer 354 milliliter [mL]/12 ounce [oz], wine 118 mL/4 oz, or distilled spirits 29.5 mL/1 oz).
  6. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
  7. Has a substance abuse disorder.

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: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]-TAK-954 0.5 mg
[14C]-TAK-954 0.5 milligram (mg), (containing approximately 1.5 microcurie [µCi] of radioactive tracer), administered as 60-minute infusion, intravenously, once on Day 1.
[14C]-TAK-954 intravenous infusion.

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
Cumulative Percentage of Administered Radioactivity Recovered in Urine
大体时间:Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Administered Radioactivity Recovered in Feces
大体时间:Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Radioactivity in Urine and Feces Combined
大体时间:Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
大体时间:Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
大体时间:Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
大体时间:Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Mean Percent of Total Radioactivity in Plasma for TAK-954 and TAK-954 Metabolites
大体时间:Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Cumulative Percentage of Dose Excreted in Urine for TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Dose Excreted in Feces for TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cmax: Maximum Observed Plasma and Whole Blood Concentrations of Radioactivity for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-954 and TAK-954 Metabolites
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 and TAK-954 Metabolites
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to Infinity for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 and TAK-954 Metabolites
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-954 and TAK-954 Metabolites
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life of Radioactivity in Plasma and Whole Blood for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life in Plasma for TAK-954 and TAK-954 Metabolites
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance After Intravenous Administration for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance of TAK-954 After Intravenous Administration of [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Urine: Amount of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Urine: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Feces: Amount of Total Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Urine: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Urine: Fraction of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Feces: Fraction of Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose

次要结果测量

结果测量
大体时间
Ratio of Total Radioactivity in Whole Blood to Plasma
大体时间:Day 1 pre-dose and at multiple time points (up to 264 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 264 hours) post-dose
Ratio of AUC∞: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 to Total Radioactivity in Plasma TAK-954
大体时间:Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
大体时间:Baseline up to Day 31
Baseline up to Day 31
Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation of [14C]-TAK-954
大体时间:Baseline up to Day 15
Baseline up to Day 15

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 (实际的)

2018年4月30日

初级完成 (实际的)

2018年6月1日

研究完成 (实际的)

2018年6月1日

研究注册日期

首次提交

2018年4月9日

首先提交符合 QC 标准的

2018年4月9日

首次发布 (实际的)

2018年4月18日

研究记录更新

最后更新发布 (实际的)

2019年7月29日

上次提交的符合 QC 标准的更新

2019年5月31日

最后验证

2019年5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

  • TAK-954-1005
  • U1111-1202-5762 (其他标识符:WHO)
  • NL65503.056.18 (注册表标识符:NL)
  • 2018-001181-42 (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)?

是的

IPD 计划说明

Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

[14C]-TAK-954的临床试验

3
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