- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Jiangsu
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Suzhou, Jiangsu, Porcelana
- The First Affiliated Hospital of Soochow University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Flonoltinib
75mg/100 μCi[14C] Flonoltinib
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Allocate 75mg /100 μCi[14C]flonoltinib once on an empty stomach
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Cumulative excretion rate of total radioactivity in urine and feces
Periodo de tiempo: Through 360 hours postdose
|
Through 360 hours postdose
|
|
Identify the main metabolites
Periodo de tiempo: Through 216 hours postdose
|
Through 216 hours postdose
|
|
Total radioactivity ratio in whole blood and plasma
Periodo de tiempo: Through 216 hours postdose
|
Through 216 hours postdose
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cmax
Periodo de tiempo: Through 216 hours postdose
|
Through 216 hours postdose
|
|
|
Safety endpoint
Periodo de tiempo: From dosing (Day 0) through study completion (Day 16)
|
Adverse events (AE)
|
From dosing (Day 0) through study completion (Day 16)
|
|
Tmax
Periodo de tiempo: Through 216 hours postdose
|
Through 216 hours postdose
|
|
|
AUC0-t
Periodo de tiempo: Through 216 hours postdose
|
Through 216 hours postdose
|
|
|
t1/2
Periodo de tiempo: Through 216 hours postdose
|
Through 216 hours postdose
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- FM-MB-01
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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