A Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 to China Healthy Male Subjects

Study Overview
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Brief Summary
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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

Detailed Description
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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)

Official Title
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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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: 14C-IMP4297


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 14C-IMP4297<br>In this study, one 100 mg dose of 14C IMP4297 Oral Suspension, 100 mg (100 μCi). | Drug: 14C-IMP4297<br>* 14C marked IMP4297<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum concentration) | peak concentration | 3 months | 
| Tmax | Time to peak | 3 months | 
| AUC0-inf (Area under the curve from time 0 to infinity) | area under the curve from time zero to infinity | 3 months | 
| AUC0-last (Area under the curve from time 0 to the last time with quantifiable concentration) | AUC0-last area under the curve from time zero to the time with the last quantifiable concentration | 3 months | 
| t½ (Elimination half-life) | elimination half-life | 3 months | 
| CL/F (Apparent clearance) | apparent clearance | 3 months | 
| Vz/F (apparent volume of distribution ) | apparent volume of distribution | 3 months | 
| urine and fecal samples for quantification analysis | 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 | 3 months | 
| 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. | Proportion of different metabolites，Assessment of metabolites (metabolites identification and main metabolites) in plasma/urine/faeces by liquid chromatography-radiochemical-detection | 3 months |