Healthy adult male
Conditions
Interventions
investigational material(s)
Generic name etc : [18F]APN-1607
INN of investigational material : -
Therapeutic category code : 43- Radioactive medicines
Dosage and Administration for Investigational mat
Sponsors
APRINOIA Therapeutics Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - The subject is capable of understanding this clinical study and providing written consent to participate in this study. - The subject is free of any disease potentially affecting his participation or assessments in the study on the basis of the examination at screening. - The subject makes sure to use birth control for one week after study drug administration.
Exclusion criteria
Exclusion criteria: - The subject has a clinically significant abnormal value in the laboratory test at screening. - The subject has known hypersensitivity to any ingredient of the study drug. - The subject is intolerant of prolonged restraint on a bed of a PET scanner. - The subject with poor venous access. - The subject has history of evisceration that can interferes with calculation of absorbed dose. - The subject received or plans to receive a barium swallow test within 2 weeks prior to study drug administration. - The subject has received nuclear medicine test and exposed to radiation over 20 mSv within one year prior to study drug administration. - The subject participated in the other interventional clinical study or research within three months prior to study drug administration. - The subject, in the opinion of the investigator or co-investigator, is ineligible for participation in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Adverse events, laboratory test, vital sign and ECG | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Radioactivity in whole blood and urine. Absorbed dose in major organs/tissues based on the MIRD method and effective dose. | — |
Countries
Japan
Outcome results
None listed