A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
11 de mayo de 2026 actualizado por: Eli Radiopharma
A Non Randomized, Open-Label Phase I Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Biodistribution and Radiation Dosimetry, and Preliminary Diagnostic Efficacy of [18F]Flortaucipir Injection PET Imaging in Chinese Subjects
This is a non randomized, open-label Phase I study in Chinese participants.
The goal of this clinical trial is to evaluate the safety and tolerability of a radioactive imaging agent called [18F]Flortaucipir Injection, which is used during a PET scan.
The study will also measure how the agent moves through the body (pharmacokinetics), where it goes (biodistribution), the amount of radiation exposure (radiation dosimetry), and how well it may help detect signs of disease (preliminary diagnostic efficacy).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
18
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100853
- Reclutamiento
- Chinese PLA General Hospital
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Contacto:
- Dr. Wang Ruimin, Doctor
- Número de teléfono: 86-13501151740
- Correo electrónico: wrm@yeah.net
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Signed informed consent form (ICF).
- Male or female aged 50-85 years.
- Education level sufficient to cooperate with neuropsychological testing and obtain reliable results.
Meet the following criteria related to cognitive impairment:
- CN: No history of cognitive impairment, Aβ-PET negative, MRI without clinically significant neurodegenerative changes.
- MCI: Meet core criteria for AD-related MCI, Aβ-PET positive, MRI showing neurodegenerative changes.
- AD: Meet core criteria for probable AD dementia, Aβ-PET positive, MRI showing neurodegenerative changes.
- Fertile individuals: No plan for reproduction, sperm/egg donation within 6 months after signing ICF and until 6 months after study drug administration; and agreement to use highly effective contraception (including partner).
Exclusion Criteria:
- Pregnant (positive pregnancy test at screening or before administration) or breastfeeding women.
- Major surgery within 1 month prior to screening, or planned surgery during the study period.
- Known allergy to radioactive radiation, alcohol, [18F]Flortaucipir injection, or its excipients, or other severe allergic reactions.
- Cognitive impairment due to causes other than AD.
- Clinically significant infarction or probable multi-infarct dementia.
- Current clinically significant psychiatric illness (e.g., major depression, schizophrenia).
- History of epilepsy or seizures (except febrile seizures in childhood).
- Inability to tolerate PET/MRI or presence of contraindications to PET/MRI.
- Other neurodegenerative diseases or dementias other than AD dementia.
- Any other condition that, in the investigator's opinion, makes the subject unsuitable for the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: CN (cognitively normal)
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A radioactive diagnostic agent intended for brain positron emission tomography (PET) imaging in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD), to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs).
Otros nombres:
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Experimental: MCI (mild cognitive impairment)
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A radioactive diagnostic agent intended for brain positron emission tomography (PET) imaging in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD), to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs).
Otros nombres:
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Experimental: AD (Alzheimer's disease)
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A radioactive diagnostic agent intended for brain positron emission tomography (PET) imaging in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD), to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Periodo de tiempo: 6 days post-injection
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6 days post-injection
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound
Periodo de tiempo: Up to 360 mins
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Cmax is defined as the highest observed plasma concentration of total radioactivity (measured by gamma counting) and of the unmetabolized parent [18F]Flortaucipir
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Up to 360 mins
|
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Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound
Periodo de tiempo: Up to 360 mins
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Tmax is the time (in minutes) at which the maximum plasma concentration (Cmax) occurs, recorded as the midpoint of the sampling interval during which the maximum is observed.
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Up to 360 mins
|
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Terminal Half-Life (t½) of Unmetabolized Parent Compound
Periodo de tiempo: Up to 360 mins
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Up to 360 mins
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|
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Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Unmetabolized Parent Compound
Periodo de tiempo: Up to 360 mins
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AUC0-t is calculated using the linear trapezoidal rule from time 0 to the last measurable concentration.
AUC0-∞ is extrapolated as AUC0-t + Ct/λz, where Ct is the last quantifiable concentration and λz is the terminal elimination rate constant.
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Up to 360 mins
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Percentage of Unmetabolized Parent Compound in Plasma
Periodo de tiempo: Up to 360 mins
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Up to 360 mins
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Urinary Radioactive Excretion Rate
Periodo de tiempo: 0-60, 60-120, 120-240, 240-360 mins post-injection
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Rate of radioactivity excreted in urine, expressed as percentage of injected dose per hour (%ID/h).
Measured by gamma counting of collected urine aliquots over specified intervals.
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0-60, 60-120, 120-240, 240-360 mins post-injection
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Cumulative Urinary Excretion of Radioactivity
Periodo de tiempo: Up to 360 mins post-injection
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Total cumulative percentage of the injected radioactive dose recovered in urine over time.
Calculated as the sum of radioactivity excreted at each collection interval.
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Up to 360 mins post-injection
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Percentage of Unmetabolized Parent Compound and Metabolites in Urine
Periodo de tiempo: Up to 360 mins post-injection
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Relative proportion of total urinary radioactivity that corresponds to the intact [18F]Flortaucipir and its known radioactive metabolites.
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Up to 360 mins post-injection
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Organ/Tissue Radioactivity Uptake - Percent Injected Dose (%ID)
Periodo de tiempo: Up to 240 mins post-injection
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Percentage of the injected radioactive dose (%ID) present in each target organ or tissue (e.g., brain, liver, kidneys, lungs, bone marrow, etc.) at specified imaging time points.
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Up to 240 mins post-injection
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Mean Standardized Uptake Value (SUVmean) in Target Organs/Tissues
Periodo de tiempo: Up to 240 mins post-injection
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SUVmean is defined as the mean tissue radioactivity concentration (decay-corrected) normalized by injected dose per body weight.
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Up to 240 mins post-injection
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Residence Time (Source Organ Time-Integrated Activity)
Periodo de tiempo: Up to 240 mins post-injection
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Residence time (also known as time-integrated activity coefficient) for each source organ, expressed as hours (or minutes).
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Up to 240 mins post-injection
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Absorbed Dose to Target Organs/Tissues
Periodo de tiempo: Up to 240 mins post-injection
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Absorbed dose (mGy) to each target organ/tissue (e.g., brain, liver, kidneys, urinary bladder wall, lungs, red marrow, heart wall, spleen, thyroid, etc.) per unit administered activity (mGy/MBq).
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Up to 240 mins post-injection
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Effective Dose (Whole-Body)
Periodo de tiempo: Up to 240 mins post-injection
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Up to 240 mins post-injection
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Visual Read Positivity Rate - Overall and by Subject Subgroup
Periodo de tiempo: At 80 mins post-injection
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Proportion of subjects with a positive PET scan based on visual assessment (blinded, independent readers) using a predefined read criterion
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At 80 mins post-injection
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Standardized Uptake Value Ratio (SUVR) - Composite Region
Periodo de tiempo: At 80 mins post-injection
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SUVR is calculated as the mean standardized uptake value (SUV) in a composite target region of interest
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At 80 mins post-injection
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de abril de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
26 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2026
Publicado por primera vez (Actual)
12 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ELI-101-001
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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