A Clinical Trial of the Absorption, Metabolism, and Excretion of [14C]IMP4297 in Chinese Adult Male Healthy Volunteers - A Human Material Balance and Biotransformation Study of [14C]IMP4297
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Cmax (Maximum concentration)
研究概览
简要总结
A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects
详细描述
Study design A Phase I, single-center, open-label, single arm study is designed to evaluate Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 Following a Single Oral Dose to China Healthy Male Subjects.
6-8 subjects are planned to be enrolled (at least 6 subjects complete the study)
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Volunteers must meet all of the following inclusion criteria to be included in the study:
- •Volunteers must fully understand the objective, nature, methods and possible adverse reactions of the trial, volunteer to be volunteers, and sign an informed consent form before the start of any study procedures, and at the same time guarantee that the volunteers will personally participate in the study during any procedures.
- •Chinese healthy male volunteers aged between 18 and 55 (including cut-off values) at the time of screening.
- •Volunteers with a body mass index (BMI) of 18.0-28.0 kg/m2 (including cut-off values), and a body weight of ≥ 50.0 kg.
排除标准
- •Volunteers who meet any of the following criteria cannot be included in this study:
- •Diseases with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bones.
- •A history of allergic diseases (including drug allergies and food allergies, etc.).
- •A history of any gastrointestinal diseases that will affect drug absorption such as dysphagia, irritable bowel syndrome, and inflammatory bowel disease; active hemorrhoids or perianal diseases accompanied by regular/current blood in the stool; habitual constipation or diarrhea.
- •Those who have undergone surgery within 3 months before screening, or who plan to undergo surgery during the study period, and those who have undergone surgery that will affect drug absorption, metabolism, or excretion.
- •Those who cannot tolerate venipuncture, and those who have a history of needke sickness and blood phobia.
研究组 & 干预措施
14C-IMP4297
In this study, one 100 mg dose of 14C IMP4297 Oral Suspension, 100 mg (100 μCi).
干预措施: 14C-IMP4297 (Drug)
结局指标
主要结局
Cmax (Maximum concentration)
时间窗: 3 months
peak concentration
Tmax
时间窗: 3 months
Time to peak
AUC0-inf (Area under the curve from time 0 to infinity)
时间窗: 3 months
area under the curve from time zero to infinity
AUC0-last (Area under the curve from time 0 to the last time with quantifiable concentration)
时间窗: 3 months
AUC0-last area under the curve from time zero to the time with the last quantifiable concentration
t½ (Elimination half-life)
时间窗: 3 months
elimination half-life
CL/F (Apparent clearance)
时间窗: 3 months
apparent clearance
Vz/F (apparent volume of distribution )
时间窗: 3 months
apparent volume of distribution
urine and fecal samples for quantification analysis
时间窗: 3 months
Assessment of recovery percent in urine and feces by liquid chromatography-radiochemical-detection。 Get Percent (%) of each radiolabeled drug-related material will be determined in urine and feces
After oral administration of [14C] IMP4297 in healthy volunteers, radioactive metabolite spectrogram are obtained to identify the main metabolites and clarify the main biotransformation pathways.
时间窗: 3 months
Proportion of different metabolites，Assessment of metabolites (metabolites identification and main metabolites) in plasma/urine/faeces by liquid chromatography-radiochemical-detection
次要结局
未报告次要终点