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

Abe Hiroki0 个研究点目标入组 5 人开始时间: 2023年7月15日最近更新: 2023年10月17日

试验速览

阶段: Unknown
状态: 招募中
发起方
入组人数: 5

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 < 40age old（—）
性别: Male

入选标准

•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.

排除标准

•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

研究者

发起方

Abe Hiroki

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