NCT06832540

Mass Balance Study of [14C] TJ0113 in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hangzhou PhecdaMed Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Mass Balance Study of \[14C\] TJ0113 in Healthy Chinese Subjects

Detailed description

This is a single-center, single-dose and open-label trial designed to enroll 6-8 healthy adult male subjects to evaluate the mass balance of \[14C\]TJ0113 in these subjects. Each subject will receive a single oral dose of approximately 200 mg /100 μCi \[14C\]TJ0113 oral formulation; after administration, blood, urine, and stool samples will be collected at specified time points/intervals during the study. The total radioactivity in whole blood and plasma, as well as the plasma concentrations of TJ0113 and its metabolites will be determined to calculate the pharmacokinetic (PK) parameters of \[14C\]TJ0113 and its metabolites in plasma and whole blood as well as the PK parameters of TJ0113 and its metabolites in plasma, and to understand the distribution of total radioactivity in whole blood and plasma; the radioactivity in urine and feces will be determined to obtain the data on total recovery, excretion and main routes of excretion; the metabolic pathways of TJ0113 in humans will be determined through radiolabeled metabolite profiling and structural identification of major metabolites in plasma, urine, and feces.

Conditions

• Healthy Chinese Subjects

Interventions

Type	Name	Description
DRUG	[14C]TJ0113	Subjects will receive a single oral dose of approximately 200 mg/100 μCi of the oral formulation of \[14C\] TJ0113 under fasted conditions.

Timeline

• Start date: 2025-02-19
• Primary completion: 2025-03-05
• Completion: 2025-03-05
• First posted: 2025-02-18
• Last updated: 2025-11-17

Locations

1 site across 1 country: China