A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy
11 mai 2026 mis à jour par: 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).
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
18
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100853
- Recrutement
- Chinese PLA General Hospital
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Contact:
- Dr. Wang Ruimin, Doctor
- Numéro de téléphone: 86-13501151740
- E-mail: wrm@yeah.net
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: CN (cognitively normal)
|
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).
Autres noms:
|
|
Expérimental: MCI (mild cognitive impairment)
|
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).
Autres noms:
|
|
Expérimental: AD (Alzheimer's disease)
|
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).
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Délai: 6 days post-injection
|
6 days post-injection
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound
Délai: Up to 360 mins
|
Cmax is defined as the highest observed plasma concentration of total radioactivity (measured by gamma counting) and of the unmetabolized parent [18F]Flortaucipir
|
Up to 360 mins
|
|
Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound
Délai: Up to 360 mins
|
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.
|
Up to 360 mins
|
|
Terminal Half-Life (t½) of Unmetabolized Parent Compound
Délai: Up to 360 mins
|
Up to 360 mins
|
|
|
Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Unmetabolized Parent Compound
Délai: Up to 360 mins
|
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.
|
Up to 360 mins
|
|
Percentage of Unmetabolized Parent Compound in Plasma
Délai: Up to 360 mins
|
Up to 360 mins
|
|
|
Urinary Radioactive Excretion Rate
Délai: 0-60, 60-120, 120-240, 240-360 mins post-injection
|
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.
|
0-60, 60-120, 120-240, 240-360 mins post-injection
|
|
Cumulative Urinary Excretion of Radioactivity
Délai: Up to 360 mins post-injection
|
Total cumulative percentage of the injected radioactive dose recovered in urine over time.
Calculated as the sum of radioactivity excreted at each collection interval.
|
Up to 360 mins post-injection
|
|
Percentage of Unmetabolized Parent Compound and Metabolites in Urine
Délai: Up to 360 mins post-injection
|
Relative proportion of total urinary radioactivity that corresponds to the intact [18F]Flortaucipir and its known radioactive metabolites.
|
Up to 360 mins post-injection
|
|
Organ/Tissue Radioactivity Uptake - Percent Injected Dose (%ID)
Délai: Up to 240 mins post-injection
|
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.
|
Up to 240 mins post-injection
|
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Mean Standardized Uptake Value (SUVmean) in Target Organs/Tissues
Délai: Up to 240 mins post-injection
|
SUVmean is defined as the mean tissue radioactivity concentration (decay-corrected) normalized by injected dose per body weight.
|
Up to 240 mins post-injection
|
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Residence Time (Source Organ Time-Integrated Activity)
Délai: Up to 240 mins post-injection
|
Residence time (also known as time-integrated activity coefficient) for each source organ, expressed as hours (or minutes).
|
Up to 240 mins post-injection
|
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Absorbed Dose to Target Organs/Tissues
Délai: Up to 240 mins post-injection
|
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).
|
Up to 240 mins post-injection
|
|
Effective Dose (Whole-Body)
Délai: Up to 240 mins post-injection
|
Up to 240 mins post-injection
|
|
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Visual Read Positivity Rate - Overall and by Subject Subgroup
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
23 avril 2026
Achèvement primaire (Estimé)
31 décembre 2026
Achèvement de l'étude (Estimé)
31 mars 2027
Dates d'inscription aux études
Première soumission
26 avril 2026
Première soumission répondant aux critères de contrôle qualité
5 mai 2026
Première publication (Réel)
12 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ELI-101-001
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .