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NOT YET RECRUITING
NCT07411742
PHASE1

Mass Balance Study of [14C] D-2570

Sponsor: InventisBio Co., Ltd

View on ClinicalTrials.gov

Summary

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.

Official title: Mass Balance Study of [14C] D-2570 in Chinese Healthy Adult Male Subjects

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2026-03-04

Completion Date

2026-04-30

Last Updated

2026-02-17

Healthy Volunteers

Yes

Interventions

DRUG

[14C] D-2570 group

\[14C\] labeled D-2570