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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026357

Enrollment

Registered

2017-03-06

Start date

2017-03-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

[11C]K-2 370MBq [11C]K-2 555MBq

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Japanese healthy male volunteer 2. Age is between 20-40 3. BMI is between 18.5-25.0

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

Measure	Time frame
Effective dose of [11C]K-2 in human	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public Contactsayoko nakashima

Yokohama City University Y-NEXT

sayoko_n@yokohama-cu.ac.jp045-370-7994

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026