此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers

2026年9月10日 更新者：Agomab Spain S.L.U.

An Open-label, Two-part Trial to Assess the Mass-balance Recovery, Metabolite Profile, Metabolite Identification and Absolute Bioavailability of [14C] Ontunisertib in Healthy Male Participants

This is an open, two-part study in healthy male volunteers, aged 30-65 years.

This trial aims to understand how the human body absorbs, distributes, metabolizes and eliminates ontunisertib after a single oral dose of radiolabelled test medicine ([14C]ontunisertib) and determine the routes and rates of elimination of the test medicine.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is an open, two-part study in healthy male volunteers, aged 30-65 years with the trial duration of approximately 7 weeks.

In Part 1 of this study, healthy volunteers will be given a dose of test medicine orally followed by an intravenous injection of a very small dose of radiolabelled test medicine that contains a tiny amount of radioactivity (called carbon-14) so that the test medicine can be traced in the blood.

In Part 2, single doses of test medicine will be administered orally to find out how the body breaks down and gets rid of the test medicine. The test medicine will be 'radiolabelled' - it will contain a small amount of radioactivity (Carbon-14) - so that it can be traced in the body.

Participants will take part in both study parts and will remain resident in the clinic for up to 10 days after their final dose of Investigation Medicinal Product (IMP). After the participants have left the clinic, they may have to collect their urine and faeces at home until mass balance criteria has been met.

Over a period of at least 8 days in Part 1 and 10 days in Part 2, many blood samples will be taken, and volunteers will collect all their urine and faeces so that the amount of test medicine and its breakdown products can be measured/analysed.

A blood sample will be taken from volunteers between admission and first dose for pharmacogenetic testing.

研究类型

介入性

注册 (估计的)

8

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。

学习联系方式

学习地点

  • 英国
      • Nottingham、英国、NG11 6JS
        • 招聘中
        • Quotient Sciences Limited

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

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Males aged 30 to 65 years inclusive at the time of signing informed consent
  • Must agree to the use of an adequate method of contraception for up to 93 days post-final dose
  • Healthy male participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and laboratory safety tests without any clinically significant abnormalities.
  • Body mass index of 18.0 to 29.9 kg/m2

Exclusion Criteria:

  • Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
  • History of clinically significant renal, hepatic, respiratory, particularly GI disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome, and neurological or psychiatric disorder
  • History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)
  • Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator at screening.
  • Radiation exposure, including that from the present trial, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the trial
  • Participants who have been administered IMP in an ADME trial or any trial involving administration of 14C radioactivity in the last 12 months
  • Male participants with pregnant or lactating partners

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：非随机化
  • 介入模型：顺序分配
  • 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：Ontunisertib
Participants will receive single oral dose of ontunisertib
药品：Ontunisertib
Oral capsule
其他名称：
  • AGMB-129
实验性的：[14C]ontunisertib solution for infusion
Participants will receive single IV dose of [14C]ontunisertib
药品：[14C]ontunisertib
IV infusion
药品：[14C]ontunisertib
Oral capsule
实验性的：[14C]ontunisertib
Participants will receive single oral dose of [14C]ontunisertib
药品：[14C]ontunisertib
IV infusion
药品：[14C]ontunisertib
Oral capsule

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
Absolute bioavailability of ontunisertib following oral and IV administration
大体时间：Through study completion, an average of 8 days
Part 1: To determine the absolute oral bioavailability of ontunisertib
Through study completion, an average of 8 days
Cumulative amount of total radioactivity excreted in urine and feces
大体时间：Through study completion, an average of 10 days
Part 2: To determine the mass balance recovery after a single oral dose of [14C]ontunisertib
Through study completion, an average of 10 days
Chemical structure of each metabolite accounting for ≥10% of circulating total radioactivity and Metabolite profiling accounting for >80% of total radioactivity recovered in urine and/or feces
大体时间：Through study completion, an average of 10 days
Part 2: To characterize the metabolite profile in plasma and excreta (urine and/or feces) after a single oral dose of [14C]ontunisertib
Through study completion, an average of 10 days

次要结果测量

结果测量
措施说明
大体时间
PK parameter (AUClast)
大体时间：Through study completion, an average of 8 days
Part 1: To characterize the IV PK (AUClast) of [14C]ontunisertib and total radioactivity in plasma
Through study completion, an average of 8 days
Cumulative amount of total radioactivity excreted in urine and feces following IV administration
大体时间：Through study completion, an average of 8 days
Part 1: To determine the mass balance recovery after a single IV dose of [14C]ontunisertib
Through study completion, an average of 8 days
PK parameter (AUClast)
大体时间：Through study completion, an average of 18 days
Part 1 and Part 2: To characterize the plasma PK (AUClast) of ontunisertib and metabolites and total radioactivity (Part 2 only) following a single oral dose
Through study completion, an average of 18 days
Whole blood-to-plasma concentration ratios for total radioactivity
大体时间：Through study completion, an average of 10 days
Part 2: To evaluate the extent of distribution of total radioactivity into blood cells
Through study completion, an average of 10 days
Number of participants with adverse events (AEs)
大体时间：Through study completion, an average of 18 days
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Through study completion, an average of 18 days
Number of participants with abnormal physical examinations
大体时间：Through study completion, an average of 18 days
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Through study completion, an average of 18 days
Number of participants with abnormal vital signs
大体时间：Through study completion, an average of 18 days
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Through study completion, an average of 18 days
Number of participants with abnormal ECGs parameters
大体时间：Through study completion, an average of 18 days
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Through study completion, an average of 18 days
Number of participants with abnormal clinical laboratory safety tests
大体时间：Through study completion, an average of 18 days
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
Through study completion, an average of 18 days
Chemical structure analysis of metabolites accounting for ≥10%
大体时间：Through study completion, an average of 8 days
Part 1: To characterize the metabolites profile in plasma following an IV dose of [14C]ontunisertib
Through study completion, an average of 8 days

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

Agomab Spain S.L.U.

调查人员

  • 研究主任：Silke Hüttner, MD、Agomab Therapeutics

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)

2026年9月9日

初级完成 (估计的)

2026年9月26日

研究完成 (估计的)

2026年9月26日

研究注册日期

首次提交

2026年6月12日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月29日

研究记录更新

最后更新发布 (实际的)

2026年9月11日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • AGMB129-01-CL-105

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

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.

订阅