Material Balance Study of [14C] Flonoltinib Maleate

A Single-Center, Non-Randomized, Open-Label, Single-Dose Material Balance Study of [14C]Flonoltinib Maleate in Healthy Subjects

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.

Study Overview

• Status: Not yet recruiting
• Conditions: MF
• Intervention / Treatment: Drug: Flonoltinib 75mg

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wang Fangmei; Phone Number: 13808086495; Email: fangmei.wang@zenitar.cn

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • the First Affiliated Hospital of Soochow University
      • Contact: Lu Zhoulin; Phone Number: +86 512-67972861; Email: sdfyec@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Chinese healthy adult male, aged 18-45 years old
2. Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2
3. Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.

Exclusion Criteria:

1. Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR ^ 0.33)) corrected QT interval (QTcF)>450 milliseconds
2. HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test
3. Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results
4. Individuals who have consumed any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) within 48 hours prior to check-in, and have engaged in vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. Or those who are unable to stop eating any food or beverage containing alcohol, grapefruit juice/grapefruit juice, or methylxanthine (such as coffee, tea, cola, chocolate, functional drinks) during the trial period, and cannot avoid vigorous exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc
5. Engaged in workers who require long-term exposure to radioactive conditions, or have significant radiation exposure (>=2 chest/abdominal CT scans, or >= 3 other types of X-ray examinations) within 1 year before administration, or have participated in radiopharmaceutical labeling tests within 1 year
6. Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flonoltinib; 75mg/100 μCi[14C] Flonoltinib	Drug: Flonoltinib 75mg; Allocate 75mg /100 μCi[14C]flonoltinib once daily on an empty stomach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative excretion rate of total radioactivity in urine and feces	Through 360 hours postdose
Identify the main metabolites	Through 216 hours postdose
Total radioactivity ratio in whole blood and plasma	Through 216 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax		Through 216 hours postdose
Safety endpoint	Adverse events (AE)	From dosing (Day 0) through study completion (Day 16)
Tmax		Through 216 hours postdose
AUC0-t		Through 216 hours postdose
t1/2		Through 216 hours postdose

Collaborators and Investigators

• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FM-MB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No