A clinical study to investigate the intracerebral dynamics of [18F]K-40 in healthy volunteers.

JRCT ID: jRCTs031220226

Registered date:27/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 01/09/2022
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Administration of an unapproved drug

Outcome(s)

• Primary Outcome: "Volume of distribution" and "Receptor concentration" of [18F]K-40 elucidated based on kinetic analysis and blood metabolite analysis of [18F]K-40.

Secondary Outcome

1. Correlation of AMPA receptor densities (SUVRs) between [18F] K-40 and [11C] K-2.
2. Optimization of imaging time suitable for [18F]K-40.
3. Adverse events that are observed in study subjects for 1-week after [18F]K-40 PET examination .

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1. Males between 20 and 40 years old at the time of obtaining informed consent.
2. Males who have no history of neuropsychiatric disorders.
3. Males who have the ability to express a choice in the MacArthur Competence Assessment Tool (MacCAT), and written consents are provided by them
4. Males who have no current mental disorders without meeting any criteria in SCID-I /DSM-IV,DSM-5, ICD-10.

Exclude criteria

1. Males who are taking psychotropic drugs, antidepressant, hypnotic, anxiolytic, antipsychotic.
2. Males who are taking prescription drugs other than those listed in criteria1 and cannot stop taking them one week prior to the PET examinations.
3. Males who are known to be hypersensitive to ethanol.
4. Males who have neurological diseases (neurodegenerative disease, minor cerebral hemorrhage or cerebral infarction).
5. Males who have history of brain tumor.
6. Males who have history of epilepsy.
7. Males who are taking medical treatment for other diseases.
8. Males who have substance-related disorders within 6 months except for nicotine and caffeine.
9. Males who show positive to addiction drugs in urine drug screening.
10. Males who have a pacemaker or any metal devices in the body.
11. Males whose head, neck and body size are not suitable for MRI scanner.
12. Males who have big tattoos and art makeups on their skins.
13. Males who have severe claustrophobia.
14. Males who have congenital or traumatic brain abnormalities.
15. Males who have abnormal laboratory standard values in blood test, biochemical test, coagulation / fibrinolysis system test, urinalysis at the time of screening (However, the case whose data is considered safe by the investigator or the sub-investigator in terms of comprehensive medical findings can be permitted to participate).
16. Males who have abnormal 12-lead ECG and vital signs at the screening (e.g. Systolic blood pressure 140 mmHg or higher, pulse 80 bpm or higher, body temperature 37.5 degrees or higher). (However, the case whose data is considered safe by the investigator or the sub-investigator in terms of comprehensive medical findings can be permitted to participate)
17. Males who show positive to at least one of the infectious disease tests (HBV, HCV, HIV, syphilis).
18. Males who donate 400 mL whole blood within 3 months, 200 mL whole blood within 1 month, or component blood within 2 weeks prior to the PET examinations.
19. Males who undertake an unapproved nuclear medicine tests or clinical trials within 6 months prior to registration.
20. Males who participate other clinical trials within 12 weeks prior to registration.
21. Males who are considered inappropriate for registration by other reasons but listed above.

Related Information

• Primary Sponsor: Ichijo Sadamitsu
• Secondary Sponsor: Takahashi Takuya
• Source(s) of Monetary Support: Takeda Science Foundation,Japan Society for the Promotion of Science