Mass Balance Study of [14C] Flonoltinib Maleate
A Single-Center, Non-Randomized, Open-Label, Single-Dose Mass Balance Study of [14C]Flonoltinib Maleate in Healthy Subjects
The primary objectives are: 1. To investigate the total radioactivity in urine and feces after a single oral administration of [14C]Flonoltinib in healthy adult male participants, thereby obtaining human radioactive recovery rates and the main excretion pathways;2.Examine the spectrum of radioactive metabolites in plasma, urine, and feces, identify the main metabolites, and elucidate the main biotransformation pathways of flonotinib maleate in healthy adult male participants;3.Examine the total radioactivity in whole blood and plasma, evaluate the pharmacokinetic (PK) characteristics of total radioactivity in whole blood (if applicable) and plasma, and assess the distribution of total radioactivity in whole blood and plasma.
Secondary objective: 1. To quantitatively analyze the concentration of Flonoltinib Maleate in plasma using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and evaluate the PK characteristics of Flonoltinib Maleate in plasma;2.Evaluate the safety and tolerability of [14C]Flonoltinib Maleate after a single oral administration in healthy adult male participants.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Jiangsu
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Suzhou、Jiangsu、中国
- The First Affiliated Hospital of Soochow University
-
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Chinese healthy adult male, aged 18-45 years old
- Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
Exclusion Criteria:
- Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR ^ 0.33)) corrected QT interval (QTcF)>450 milliseconds
- HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test
- Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results
- Individuals who have consumed any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in, and have engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. Or those who are unable to stop eating any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) during the trial period, and cannot avoid vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc
- Engaged in workers who require long-term exposure to radioactive conditions, or have significant radiation exposure (>=2 chest/abdominal CT scans, or >= 3 other types of X-ray examinations) within 1 year before administration, or have participated in radiopharmaceutical labeling tests within 1 year
- Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection
学习计划
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:Flonoltinib
75mg/100 μCi[14C] Flonoltinib
|
Allocate 75mg /100 μCi[14C]flonoltinib once on an empty stomach
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Cumulative excretion rate of total radioactivity in urine and feces
大体时间:Through 360 hours postdose
|
Through 360 hours postdose
|
|
Identify the main metabolites
大体时间:Through 216 hours postdose
|
Through 216 hours postdose
|
|
Total radioactivity ratio in whole blood and plasma
大体时间:Through 216 hours postdose
|
Through 216 hours postdose
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cmax
大体时间:Through 216 hours postdose
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Through 216 hours postdose
|
|
|
Safety endpoint
大体时间:From dosing (Day 0) through study completion (Day 16)
|
Adverse events (AE)
|
From dosing (Day 0) through study completion (Day 16)
|
|
Tmax
大体时间:Through 216 hours postdose
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Through 216 hours postdose
|
|
|
AUC0-t
大体时间:Through 216 hours postdose
|
Through 216 hours postdose
|
|
|
t1/2
大体时间:Through 216 hours postdose
|
Through 216 hours postdose
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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