healthy volunteer
Conditions
Interventions
Single intravenous administration of the study drug with an injected radioactivity of 30 to 200 (maximum 370) MBq and a mass dose of not exceeding 2.5 mcg/kg. The first subject will be administered wi
Sponsors
Morita Naomi
Watanabe Yasuyoshi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy volunteer who showed his will to participate in this study and provided the informed consent 2) Age: older than 20 and younger than 64 3) Body weight: Over 50kg and Under 85 kg, BMI:Over 18.5 and Under 26.5 4) Subjects who passed the routine health screening tests and inspection by the medical doctor, and also who could be judged to corporate well with this planned clinical study.
Exclusion criteria
Exclusion criteria: 1) Serious diseases in some organs (hepatic, renal, cardiac, hematologic, and vascular diseases) 2) Subjects who have taken, either orally or topically, drugs, quasi-drugs, or health food products (e.g., supplements) within 7 days prior to the study drug administration 3) Subjects who are routinely taking medications/quasi-drugs/supplements/beverages that contain CoQ10 derivatives or who have taken those within 1 month prior to the study drug administration 4) Subjects who drink excessively on a daily basis or who have drunk excessively within 7 days 5) Subjects with a history of allergy to drugs or food 6) Subjects who are currently participating in other clinical research (including clinical trials) or who have participated in other clinical research (including clinical trials) and taken the last dose of drugs for the clinical research or trial within 4 months 7) Subjects who have donated 200 mL or more of blood within 1 month or 400 mL or more of blood within 3 months 8) Subjects for whom the investigator considers that it is better to avoid further radiation exposure according to their radiation exposure history 9) Subjects with drug or alcohol dependence 10) Subjects positive to serological test of syphilis, HIV antibody, HBs antigen, or HCV antibody 11) Subjects considered ineligible for this study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Difference of laboratory values 2) Systemic distribution of study drug and accumulation in each organ 3) Whole-body and organ dosimetry | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of the head, liver, kidneys, Splee n, and other parts where the amount of accumulat ion was higher than other parts | — |
Contacts
Public ContactYasuo Iwamoto
MI clinic
Outcome results
None listed