The Mass Balance Study of [14C]JT001

Shanghai Vinnerna Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: [14C]JT001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05802810

JT016-001-I

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

7 participants in 1 patient group

[14C]JT001

Experimental group

Treatment:

Drug: [14C]JT001