A clinical study to investigate the pharmacokinetics of [11C]K-2 in healthy volunteers.

JRCT ID: jRCT1031230235

Registered date:15/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: none
• Date of first enrollment: 15/07/2023
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Administration of the unapproved drug

Outcome(s)

• Primary Outcome: Rate constants of [11C]K-2 (K1, k2, k3 and k4)

Secondary Outcome

a. BPND calculated using the rate constants
b. BPND calculated not using the rate constants

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 known to be hypersensitive to ethanol
3. Males who have neurological diseases (neurodegenerative disease, cerebral hemorrhage or cerebral infarction)
4. Males who have histories of suicide attempts or self-harm
5. Males who have mental disorders due to past trauma
6. Males who have history of brain tumor
7. Males who have history of epilepsy
8. Males who are taking medical treatment for other diseases
9. Males who have substance-related disorders within 6 months except for nicotine and caffeine
10. Males who cannot take 3-Tesla MRI examination (3-Tesla MRI-incompatible metal implants, tattoos larger than one point (including permanent makeup), severe claustrophobia, unsuitable body shape for MRI scanners, significant abnormalities in brain structure There are (including congenital and traumatic))
11. Males who have abnormal 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)
12. 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
13. Males who undertake an unapproved nuclear medicine tests or clinical trials within 6 months prior to registration
14. Males who participate other clinical trials within 12 weeks prior to registration
15. Males who are taking prescription drugs other than psychotropic drugs or over-the-counter drugs (including herbal medicines) and cannot stop taking them one week prior to the PET examinations
16. Males who show positive to addiction drugs in urine drug screening
17. At the time of registration, any of the following abnormal laboratory test values
Serum creatinine 1.5 mg/dl or more
Serum AST 150IU/L or more
Serum ALT 150IU/L or more
18. Males who are considered inappropriate for registration by other reasons but listed above

Related Information

• Primary Sponsor: Abe Hiroki
• Source(s) of Monetary Support: Takeda Science Foundation, Japan Society For The Promotion of Science