The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
NCT Number: NCT07612306
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.
Trial opening soon.
Get Notified18 year–45 year
Male
Interventional
Phase 1
Suzhou, Jiangsu, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Allocate 75mg /100 μCi[14C]flonoltinib once daily on an empty stomach
Time frame: Through 360 hours postdose
Time frame: Through 216 hours postdose
Time frame: Through 216 hours postdose
Time frame: Through 216 hours postdose
Time frame: From dosing (Day 0) through study completion (Day 16)
Adverse events (AE)
Time frame: Through 216 hours postdose
Time frame: Through 216 hours postdose
Time frame: Through 216 hours postdose
Contact information is provided by the study sponsor or research team.
Chengdu Zenitar Biomedical Technology Co., Ltd
Industry
A Single-Center, Non-Randomized, Open-Label, Single-Dose Material Balance Study of [14C]Flonoltinib Maleate in Healthy Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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