Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07580703

A Phase I Study of [18F]Flortaucipir PET Imaging in Chinese Subjects: Safety, Pharmacokinetics, Biodistribution, Radiation Dosimetry, and Preliminary Diagnostic Efficacy

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

AD - Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia MCI Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Dr. Wang Ruimin, Doctor

CONTACT

[email protected]

86-13501151740

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[18F]Flortaucipir Injection

Drug

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).

Other names: ELI-101

Primary outcomes

  1. Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 6 days post-injection

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) - Total Radioactivity and Parent Compound

    Time frame: 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

  2. Time to Reach Cmax (Tmax) - Total Radioactivity and Parent Compound

    Time frame: 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.

  3. Terminal Half-Life (t½) of Unmetabolized Parent Compound

    Time frame: Up to 360 mins

  4. Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Unmetabolized Parent Compound

    Time frame: 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.

  5. Percentage of Unmetabolized Parent Compound in Plasma

    Time frame: Up to 360 mins

  6. Urinary Radioactive Excretion Rate

    Time frame: 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.

  7. Cumulative Urinary Excretion of Radioactivity

    Time frame: 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.

  8. Percentage of Unmetabolized Parent Compound and Metabolites in Urine

    Time frame: Up to 360 mins post-injection

    Relative proportion of total urinary radioactivity that corresponds to the intact [18F]Flortaucipir and its known radioactive metabolites.

  9. Organ/Tissue Radioactivity Uptake - Percent Injected Dose (%ID)

    Time frame: 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.

  10. Mean Standardized Uptake Value (SUVmean) in Target Organs/Tissues

    Time frame: Up to 240 mins post-injection

    SUVmean is defined as the mean tissue radioactivity concentration (decay-corrected) normalized by injected dose per body weight.

  11. Residence Time (Source Organ Time-Integrated Activity)

    Time frame: Up to 240 mins post-injection

    Residence time (also known as time-integrated activity coefficient) for each source organ, expressed as hours (or minutes).

  12. Absorbed Dose to Target Organs/Tissues

    Time frame: 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).

  13. Effective Dose (Whole-Body)

    Time frame: Up to 240 mins post-injection

  14. Visual Read Positivity Rate - Overall and by Subject Subgroup

    Time frame: At 80 mins post-injection

    Proportion of subjects with a positive PET scan based on visual assessment (blinded, independent readers) using a predefined read criterion

  15. Standardized Uptake Value Ratio (SUVR) - Composite Region

    Time frame: At 80 mins post-injection

    SUVR is calculated as the mean standardized uptake value (SUV) in a composite target region of interest

Sponsors and collaborators

Lead sponsor

Eli Radiopharma

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 12, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.