Material Balance Study of [14C] Flonoltinib Maleate
ConditionMF
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorChengdu Zenitar Biomedical Technology Co., Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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/m²
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Flonoltinib 75mg
DrugAllocate 75mg /100 μCi\[14C\]flonoltinib once daily on an empty stomach
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: FlonoltinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative excretion rate of total radioactivity in urine and feces
Time frame
Through 360 hours postdose2
Identify the main metabolites
Time frame
Through 216 hours postdose3
Total radioactivity ratio in whole blood and plasma
Time frame
Through 216 hours postdoseSecondary outcomes
1
Cmax
Time frame
Through 216 hours postdose2
Safety endpoint
Adverse events (AE)
Time frame
From dosing (Day 0) through study completion (Day 16)3
Tmax
Time frame
Through 216 hours postdose4
AUC0-t
Time frame
Through 216 hours postdoseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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