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First-in-human study of [18F]MC225

First-in-human study for effectiveness and safety of [18F]MC225 to evaluate p-glycoprotein function

Status
Active, not recruiting
Phases
Phase 1
Study type
Unknown
Source
JPRN
Registry ID
JPRN-jRCTs031190136
Enrollment
11
Registered
2019-11-20
Start date
2019-11-20
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 [18F]MC225

Sponsors

Ishii Kenji
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: The following criteria must be met by ALL Subjects: 1. Male subjects aged between 20 and 60 years at the informed consent 2. Subjects who provide written informed consent.

Exclusion criteria

Exclusion criteria: Subjects who have any of the following present or past history of illness: 1. Past history of neuropsychiatric disorders such as epilepsy, major depression, or schizophrenia 2. Subjects who are currently taking prescription drugs, general pharmaceuticals, quasi-drugs, and health food products (suppliments) 3. Smorkers 4. Subjects who drink alcohol the day before or the day of the visit 5. Subjects who have contraindication of or being inadicuate for MRI 6. Subjects who have past history of severe drug hypersensitivity 7. Subjects who have past history of cardiovascular diseases 8. Subjects who are currently suffering from chronic anemia, chronic renal failure, or any other significant diseases 9. Subjects who are judged as ineligible for the study by the principal investigator

Design outcomes

Primary

MeasureTime frame
1. Human radiation dosimetry of [18F]MC225 2. Safty of intravenous administration of [18F]MC225 3. Pharmakokinetics of [18F]MC225 (metabolism, blood clearance, urine extraction rate)

Secondary

MeasureTime frame
1. Optimization of data acquisition methods and scanning protocol 2. Establishment of quantification 3. Building appropriate methods for image evaluation and analysis

Contacts

Public ContactMami Yoshioka

Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology

mami_yoshioka@tmghig.jp+81-3-3964-3241

Outcome results

None listed

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