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Material Balance Study of [14C] Flonoltinib Maleate
Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd
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.
Official title: A Single-Center, Non-Randomized, Open-Label, Single-Dose Material Balance Study of [14C]Flonoltinib Maleate in Healthy Subjects
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2026-06-30
Completion Date
2026-12-30
Last Updated
2026-05-28
Healthy Volunteers
Yes
Conditions
Interventions
Flonoltinib 75mg
Allocate 75mg /100 μCi\[14C\]flonoltinib once daily on an empty stomach
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China