Healthy Subjects
Conditions
Brief summary
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.
Interventions
DRUG[14C]JT001
Subjects will receive approximately 300 mg/100 µCi of \[14C\]JT001 orally.
Sponsors
Sponsor GmbH
Shanghai Vinnerna Biosciences Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult males 2. Age: 18-45 years old 3. 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; 4. Voluntarily sign informed consent; 5. Subjects were able to complete the trail according to protocol.
Exclusion criteria
1. Physical examination, vital signs, routine laboratory examination, imaging examination abnormal and clinically significant 2. The electrocardiogram was abnormal and was considered clinically significant by the investigators, or has a history of organic heart disease 3. Has hepatitis B (HBV) or hepatitis C (HCV) or HIV antibody and syphilis antibody positive; 4. Any drug that inhibits or induces the drug transporters P-gp and BCRP has been used within 30 days prior to the screening period 5. Any conditions that may affect drug absorption. 6. Previous antineoplastic therapy meets washout requirements. 7. Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease 8. Habitual constipation or diarrhea. 9. Significant radioactive exposure within 1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak concentration（Cmax） | 1 month | The highest plasma drug concentration that can be achieved after medication |
| Total radioactive recovery | 1 month | The percentage of radioactivity recovered from collected samples |
| cumulative excretion rate of total radioactive material in fecal matter | 1 month | After oral administration of the drug, the subjects collected feces for 10 Days to obtain the excretion of accumulated radioactive substances in feces |
| Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS) | 1 month | The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS) |
| time to peak（Tmax） | 1 month | After a single dose, the time of peak blood concentration |
| elimination half life（t1/2） | 1 month | the time it takes the blood to reduce the concentration of the drug to half |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | 2 month | Number of cases and incidence of adverse events(AEs) |
Countries
China
Outcome results
None listed