The Mass Balance Study of [14C]JT001

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802810
• Other study ID #: JT016-001-I
• Status: Recruiting
• Phase: Phase 1
• Start date: March 18, 2023
• Est. completion date: October 15, 2023

Study information

• Verified date: February 2023
• Source: Shanghai Vinnerna Biosciences Co., Ltd.
• Contact: Kai Xu, Project manager
• Phone: +86 13761020175
• Email: kai_xu[@]junshipharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: October 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• [14C]JT001
Subjects will receive approximately 300 mg/100 µCi of [14C]JT001 orally.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Vinnerna Biosciences Co., Ltd.	Sponsor GmbH

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radioactive recovery	The percentage of radioactivity recovered from collected samples	1 month
Primary	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
Primary	Peak concentration(Cmax)	The highest plasma drug concentration that can be achieved after medication	1 month
Primary	time to peak(Tmax)	After a single dose, the time of peak blood concentration	1 month
Primary	elimination half life(t1/2)	the time it takes the blood to reduce the concentration of the drug to half	1 month
Primary	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	Adverse events (AEs)	Number of cases and incidence of adverse events(AEs)	2 month