Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000026357
- Lead Sponsor
- Yokohama City University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 12
Not provided
(Exclusion criteria at the stage of screening) 1. The man who has past or current history of psychiatric disorder and another severe illness 2. Current smoker or past smoker who quit smoking within 6 months 3. The man who is disclosed brain disease by MRI study 4. The man who shows deviation from the standard in laboratory tests 5. The man whose eGFR is under 60 6. The man who has abnormal finding in ECG, brain MRI and vital signs 7. The man who is positive in infectious disease test 8. The man who can not undergo MRI and PET examination by reasons of metal inside the body, tattoos and claustphobia 9. The man who participates in clinical trial where he underwent nuclear medicine scan or CT scan within 6 months 10. The man who donates his blood 400ml within 12 weeks or 200ml within 4 weeks or more little within 2 weeks 11. The man who participates in other clinical trial within 3 months 12. The man who continues and cannot quit using drugs 13. The man who is suspected of alcohol hypersensitivity 14. The man who can not avoid impregnating during this trial 15. The man who is judged inadequate by the research medical doctor (Exclusion criteria at the stage of pre-PET test) 1. The man who shows deviation from the standard in laboratory tests 2. The man who has abnormal finding in vital signs 3. The man who is judged inadequate by the research medical doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effective dose of [11C]K-2 in human
- Secondary Outcome Measures
Name Time Method The safety of [11C]K-2 The time-elapsed change of serum and urine radio activity The time-elapsed change of unaltered compound and metabolites