The Mass Balance Study of [14C]JT001

Study Overview
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Brief Summary
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This study is a single center, single dose, non-randomized, open design clinical study.By quantitative analysis of the biological samples of subjects after oral administration of [14C]JT001, the data of human radioactive excretion rate and the main excretion pathway will be obtained. The main metabolites ,metabolic pathways and elimination pathways of JT001 will be identified.

Official Title
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The Mass Balance Study of [14C]JT001 in Chinese Healthy Adult Male Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: [14C]JT001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult males Age: 18-45 years old Body weight: Body mass index (BMI) is between 19.0 and 26.0 kg/m2 (including boundary values), and the body weight of the subject is not less than 50.0 kg; Voluntarily sign informed consent; Subjects were able to complete the trail according to protocol. Exclusion Criteria: Physical examination, vital signs, routine laboratory examination, imaging examination abnormal and clinically significant The electrocardiogram was abnormal and was considered clinically significant by the investigators, or has a history of organic heart disease Has hepatitis B (HBV) or hepatitis C (HCV) or HIV antibody and syphilis antibody positive; Any drug that inhibits or induces the drug transporters P-gp and BCRP has been used within 30 days prior to the screening period Any conditions that may affect drug absorption. Previous antineoplastic therapy meets washout requirements. Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease Habitual constipation or diarrhea. Significant radioactive exposure within 1 year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]JT001<br> | Drug: [14C]JT001<br>* Subjects will receive approximately 300 mg/100 µCi of [14C]JT001 orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radioactive recovery | The percentage of radioactivity recovered from collected samples | 1 month | 
| cumulative excretion rate of total radioactive material in fecal matter | After oral administration of the drug, the subjects collected feces for 10 Days to obtain the excretion of accumulated radioactive substances in feces | 1 month | 
| Peak concentration（Cmax） | The highest plasma drug concentration that can be achieved after medication | 1 month | 
| time to peak（Tmax） | After a single dose, the time of peak blood concentration | 1 month | 
| elimination half life（t1/2） | the time it takes the blood to reduce the concentration of the drug to half | 1 month | 
| Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS) | The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Number of cases and incidence of adverse events(AEs) | 2 month |