Mass Balance Study of [14C] D-2570

Radiolabeled drug substance balance clinical studies are commonly used methods to elucidate the metabolic and excretion characteristics of drugs in the human body. They are widely applied in the research and development of innovative drugs both domestically and internationally, and their safety has been validated through extensive human trials. The primary objectives of this study are as follows: To quantitatively analyze the total radioactive activity (TRA) in urine and feces, thereby determining the radioactive recovery rate in humans and identifying the primary excretion pathways. To obtain radioactive metabolite profiles in human plasma, urine, and feces, identify the major metabolites, and determine the principal metabolic and elimination pathways. To quantitatively analyze the total radioactive activity in whole blood and plasma, derive the pharmacokinetic parameters for total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of total radioactivity between whole blood and plasma.

NCT Number	NCT07411742
Lead Sponsor	InventisBio Co., Ltd
Conditions	Mass Balance Study
Enrollment	8 participants
Start Date	2026-03-10
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-29