Material Balance Study of [14C] Flonoltinib Maleate

Summary

The primary objectives are: 1. To investigate the total radioactivity in urine and feces after a single oral administration of \[14C\]Flonoltinib in healthy adult male participants, thereby obtaining human radioactive recovery rates and the main excretion pathways;2.Examine the spectrum of radioactive metabolites in plasma, urine, and feces, identify the main metabolites, and elucidate the main biotransformation pathways of fluorotinib maleate in healthy adult male participants;3.Examine the total radioactivity in whole blood and plasma, evaluate the pharmacokinetic (PK) characteristics of total radioactivity in whole blood (if applicable) and plasma, and assess the distribution of total radioactivity in whole blood and plasma. Secondary objective: 1. To quantitatively analyze the concentration of Flonoltinib Maleate in plasma using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) and evaluate the PK characteristics of Flonoltinib Maleate in plasma;2.Evaluate the safety and tolerability of \[14C\]Flonoltinib Maleate after a single oral administration in healthy adult male participants.

Timeline

Start

2026-06-30

Primary completion

2026-10-30

Completion

2026-12-30

Drugs

Indications

No indication recorded.