Material Balance Study of [14C] Flonoltinib Maleate

NCT07612306 | Not Yet Recruiting Phase 1

• 1 other identifier: FM-MB-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Cmax

  Through 216 hours postdose

• Safety endpoint

  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

Study Arms (1)

Flonoltinib

EXPERIMENTAL

75mg/100 μCi\[14C\] Flonoltinib

Drug: Flonoltinib 75mg

Interventions

Flonoltinib 75mg DRUG

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

Flonoltinib

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese healthy adult male, aged 18-45 years old
• Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m\^2
• 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.

You may not qualify if:

• Screening period electrocardiogram examination: Fridericia formula (QTcF=QT/(RR \^ 0.33)) corrected QT interval (QTcF)\>450 milliseconds
• HBsAg,HBeAg, hepatitis C antibody, treponema pallidum antibody or HIV Ag/Ab combined test
• Individuals with a history of drug abuse or drug use, or positive urine drug abuse screening results
• 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
• 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
• Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection

Sponsors & Collaborators

• Chengdu Zenitar Biomedical Technology Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Central Study Contacts

Wang Fangmei

CONTACT

13808086495; fangmei.wang@zenitar.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 28, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CN (1)