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First-in-human study of [11C]MMP

First-in-human study of the safety, pharmacokinetics and dosimetry of [11C]MMP, a diagnostic agent for regional cerebral blood flow

Status
Recruiting
Phases
Phase 1
Study type
Unknown
Source
JPRN
Registry ID
JPRN-jRCTs031250464
Enrollment
9
Registered
2025-10-29
Start date
2025-10-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal subjects

Interventions

Positron emission tomography study using un-approved ligand [11C]MMP
positron emission tomography, cerebral blood flow

Sponsors

Ishii Kenji
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Subjects who meet all of the following criteria will be included in this study: 1. Male subjects aged 20 to 60 years at the time of consent 2. Subjects who have given written consent to participate in this study

Exclusion criteria

Exclusion criteria: Subjects with any of the following diseases or medical histories will be deemed ineligible at the time of enrollment and excluded. 1. Those with a history of psychiatric and neurological disorders, such as epilepsy, major depression, or schizophrenia. 2. Those who smoke. 3. Those deemed unsuitable for head MRI examination. 4. Those with a history of severe drug hypersensitivity. 5. Those with a history of cardiovascular disease. 6. Those currently suffering from internal medical diseases, such as chronic anemia or chronic renal failure. 7. Other subjects deemed unsuitable by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Evaluation of safety associated with administration of [11C]MMP Pharmacokinetics of [11C]MMP (metabolism, blood clearance, urinary excretion rate) Evaluation of internal radiation dose associated with administration of [11C]MMP

Secondary

MeasureTime frame
1. Optimizing the method and timing of image acquisition 2. Establishing a quantitative method (calculating the brain [11C]MMP transfer rate constant and distribution volume) 3. Establishing an image evaluation and analysis method (comparison of brain [11C]MMP distribution, pharmacokinetic parameters, [15O]H2O distribution, and regional cerebral blood flow)

Contacts

Public ContactMami Yoshioka

Tokyo Metropolitan Institute for Geriatrics and Gerontology

rinsyoushiken@tmghig.jp+81-3-3964-1141

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026