How [14C]-JNT-517 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Male Participants
2026年4月30日 更新者：Otsuka Pharmaceutical Development & Commercialization, Inc.
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]JNT-517 Following a Single Oral Dose in Healthy Male Participants
The purpose of this study is to determine the absorption, metabolism and excretion of [14C]-JNT-517 and to characterize and determine the metabolites present in plasma, urine, and feces in healthy male participants following a single oral administration.
研究概览
研究类型
介入性
注册 (实际的)
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。
学习地点
-
-
Wisconsin
-
Madison、Wisconsin、美国、53704
- Fortrea Clinical Research Unit Inc.
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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
接受健康志愿者
是的
描述
Inclusion Criteria
- Body mass index (BMI) between 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive.
- In good health at screening as determined by: a) Medical history, b) Physical examination, c) ECG, d) Clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [e.g. suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable).
- History of a minimum of 1 bowel movement per day.
- Able to comprehend and are willing to sign the Informed consent form (ICF) and abide by the study restrictions.
Exclusion Criteria
- Use or intend to use any medications/products known to alter drug absorption, metabolism and excretion processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Alcohol consumption of >14 units per week.
- A Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in.
- Participants having taken an investigational drug within 30 days prior to screening.
- Participants who have previously been dosed in >2 radiolabeled drug studies in the last 12 months.
- Participants with exposure to significant diagnostic or therapeutic radiation (e.g. serial X-ray, computed tomography scan, barium meal).
- Previous exposure to JNT-517.
Note: Other protocol-specified inclusion/exclusion criteria may apply.
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：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]-JNT-517
Participants receive a single dose of [14C]-JNT-517, orally, on Day 1
|
Suspension
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Total Radioactivity Recovery (fet1-t2) in Urine and Feces
大体时间：Up to Day 9
|
Up to Day 9
|
|
Relative Amounts Of Radioactivity Excreted in Urine and Feces
大体时间：Up to Day 9
|
Up to Day 9
|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of [14C]-JNT-517 And Its Metabolites in Plasma
大体时间：Up to Day 9
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Up to Day 9
|
|
Area Under The Concentration-Time Curve From Time Zero to The Time Of The Last Quantifiable Concentration (AUC0-tlast) of [14C]-JNT-517 And Its Metabolites in Plasma
大体时间：Up to Day 9
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Up to Day 9
|
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Maximum Plasma Concentration (Cmax) of [14C]-JNT-517 And Its Metabolites in Plasma
大体时间：Up to Day 9
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Up to Day 9
|
|
Time to Reach Maximum (Peak) Observed Plasma Concentration (Tmax) of [14C]-JNT-517 And Its Metabolites in Plasma
大体时间：Up to Day 9
|
Up to Day 9
|
|
Apparent Terminal Elimination Half-Life (t½) of [14C]-JNT-517 And Its Metabolites in Plasma
大体时间：Up to Day 9
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Up to Day 9
|
|
AUC₀-∞ of Total Radioactivity in Plasma And Whole Blood
大体时间：Up to Day 9
|
Up to Day 9
|
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AUC₀-tlast of Total Radioactivity in Plasma And Whole Blood
大体时间：Up to Day 9
|
Up to Day 9
|
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Cmax of Total Radioactivity in Plasma and Whole Blood
大体时间：Up to Day 9
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Up to Day 9
|
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Tmax of Total Radioactivity in Plasma and Whole Blood
大体时间：Up to Day 9
|
Up to Day 9
|
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t½ of Total Radioactivity in Plasma and Whole Blood
大体时间：Up to Day 9
|
Up to Day 9
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
大体时间：Up to Day 9
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Up to Day 9
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Parameters
大体时间：Up to Day 9
|
Up to Day 9
|
|
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters
大体时间：Up to Day 9
|
Up to Day 9
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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)
2024年1月22日
初级完成 (实际的)
2025年1月22日
研究完成 (实际的)
2025年2月27日
研究注册日期
首次提交
2026年4月30日
首先提交符合 QC 标准的
2026年4月30日
首次发布 (实际的)
2026年5月7日
研究记录更新
最后更新发布 (实际的)
2026年5月7日
上次提交的符合 QC 标准的更新
2026年4月30日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 359-201-00003
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Small studies with less than 25 participants are excluded from data sharing.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
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.
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