The Mass Balance Study of [14C]JT001

Phase 1

Recruiting

• Conditions: Healthy Subjects
• Interventions: Drug: [14C]JT001

• Registration Number: NCT05802810
• Lead Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-17
• Study Start: 2023-03-18
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07
• Primary Completion: 2023-06-15
• Study Completion: 2023-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]JT001	[14C]JT001	-

Primary Outcome Measures

Name	Time	Method
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
time to peak（Tmax）	1 month	After a single dose, the time of peak blood concentration
Total radioactive recovery	1 month	The percentage of radioactivity recovered from collected samples
Peak concentration（Cmax）	1 month	The highest plasma drug concentration that can be achieved after medication
elimination half life（t1/2）	1 month	the time it takes the blood to reduce the concentration of the drug to half
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)

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs)	2 month	Number of cases and incidence of adverse events(AEs)

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China