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NOT YET RECRUITING
NCT07612306
PHASE1

Material Balance Study of [14C] Flonoltinib Maleate

Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

View on ClinicalTrials.gov

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

DRUG

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