Mass Balance Study of [14C] Flonoltinib Maleate (NCT07612306) | Clinical Trial Compass
CompletedPhase 1
Mass Balance Study of [14C] Flonoltinib Maleate
China6 participantsStarted 2026-07-06
Plain-language 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 flonotinib 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.
Who can participate
Age range
18 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative excretion rate of total radioactivity in urine and feces
Timeframe: Through 360 hours postdose
2
Identify the main metabolites
Timeframe: Through 216 hours postdose
3
Total radioactivity ratio in whole blood and plasma
. 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