healthy volunteer
Conditions
Interventions
Single intravenous administration of the study drug with an injected activity of 30 to 400 (maximum 740) MBq and a mass dose of not exceeding 2.5 microg/kg. The first subject will be administered with
Sponsors
Senda Michio
Watanabe Yasuyoshi
Oota Ryuuki
Takeda Consumer Healthcare Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Appropriate written informed consent 2. Aged >= 20 and = 50 kg and = 18.5 and < 26.5 4. Subjects who have been screened (height, weight, physiological examination, electrocardiography, blood and urine tests) by the investigator prior to the study drug administration, present with no findings that may influence the study, and are considered able to cooperate to complete the 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 vitamin B1 (thiamine) or vitamin B1 derivatives (e.g., fursultiamine, prosultiamine, benfotiamine, dicethiamine, octotiamine, bisbentiamine, thiamine disulfide) 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. Safety 2. Systemic distribution of study drug and accumulation in each organ 3. Whole-body and organ dosimetry | — |
Contacts
Public ContactKiyoshi Irikura
Kobe City Medical Center General Hospital
Outcome results
None listed