A Single-Center, Non-Randomized, Open-Label, Single-Dose Mass Balance Study of [14C]Flonoltinib Maleate in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Flonoltinib
75mg/100 μCi[14C] Flonoltinib
干预措施: Flonoltinib 75mg (Drug)