- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07612306
Mass Balance Study of [14C] Flonoltinib Maleate
A Single-Center, Non-Randomized, Open-Label, Single-Dose Mass 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 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.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Jiangsu
-
Suzhou, Jiangsu, Kina
- The First Affiliated Hospital of Soochow University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Flonoltinib
75mg/100 μCi[14C] Flonoltinib
|
Allocate 75mg /100 μCi[14C]flonoltinib once on an empty stomach
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Cumulative excretion rate of total radioactivity in urine and feces
Tidsram: Through 360 hours postdose
|
Through 360 hours postdose
|
|
Identify the main metabolites
Tidsram: Through 216 hours postdose
|
Through 216 hours postdose
|
|
Total radioactivity ratio in whole blood and plasma
Tidsram: Through 216 hours postdose
|
Through 216 hours postdose
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cmax
Tidsram: Through 216 hours postdose
|
Through 216 hours postdose
|
|
|
Safety endpoint
Tidsram: From dosing (Day 0) through study completion (Day 16)
|
Adverse events (AE)
|
From dosing (Day 0) through study completion (Day 16)
|
|
Tmax
Tidsram: Through 216 hours postdose
|
Through 216 hours postdose
|
|
|
AUC0-t
Tidsram: Through 216 hours postdose
|
Through 216 hours postdose
|
|
|
t1/2
Tidsram: Through 216 hours postdose
|
Through 216 hours postdose
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- FM-MB-01
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .