MedTrace Logo

Material Balance Study of [14C] Flonoltinib Maleate

NCT07612306 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-05-28

No results posted yet for this study

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.

Conditions

  • MF

Interventions

DRUG

Flonoltinib 75mg

Allocate 75mg /100 μCi\[14C\]flonoltinib once daily on an empty stomach

Sponsors & Collaborators

  • Chengdu Zenitar Biomedical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-10-30
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07612306 on ClinicalTrials.gov