Unique ID issued by UMIN | UMIN000026357 |
---|---|
Receipt number | R000030285 |
Scientific Title | Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers |
Date of disclosure of the study information | 2017/03/06 |
Last modified on | 2018/08/29 17:15:05 |
Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Clinical trial to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Japan |
Healthy volunteers
Neurology | Neurosurgery |
Others
NO
The purpose of this trial is to examine the effective dose and the safety of [11C]K-2 synthesized by dedicated machine in healthy male volunteers
Safety
Exploratory
Explanatory
Phase I
Effective dose of [11C]K-2 in human
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
No need to know
2
Diagnosis
Device,equipment |
[11C]K-2 370MBq
[11C]K-2 555MBq
20 | years-old | <= |
40 | years-old | > |
Male
1. Japanese healthy male volunteer
2. Age is between 20-40
3. BMI is between 18.5-25.0
(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
12
1st name | |
Middle name | |
Last name | Tomoyuki Miyazaki |
Yokohama City University hospital
Department of Physiology /Anesthesiology
3-9 Fukuura, Kanazawa-ward, Yokohama 236-0004
045-787-2579
johney@yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | sayoko nakashima |
Yokohama City University
Y-NEXT
1-1-1 Fukuura, Kanazawa-ward, Yokohama 236-0004
045-370-7994
sayoko_n@yokohama-cu.ac.jp
Yokohama City University
Japan Agency for Medical Research and Development
Other
NO
2017 | Year | 03 | Month | 06 | Day |
Unpublished
Completed
2017 | Year | 02 | Month | 17 | Day |
2017 | Year | 03 | Month | 06 | Day |
2017 | Year | 10 | Month | 30 | Day |
2018 | Year | 02 | Month | 16 | Day |
2017 | Year | 03 | Month | 01 | Day |
2018 | Year | 08 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030285
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |