Evaluation of the pharmacokinetics of [11C]fursultiamine in healthy volunteers

JRCT ID: jRCTs051190033

Registered date:05/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: healthy volunteer
• Date of first enrollment: 25/10/2019
• Target sample size: 3
• Study type: Interventional
• Intervention(s): 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 the activity of approximately 100 MBq.

Outcome(s)

Primary Outcome

1. Safety
2. Systemic distribution of study drug and accumulation in each organ
3. Whole-body and organ dosimetry

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Male

Include criteria

1. Appropriate written informed consent
2. Aged >= 20 and < 65 years
3. Body weight >= 50 kg and < 85 kg, BMI >= 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

Exclude 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

Related Information

• Primary Sponsor: Senda Michio
• Secondary Sponsor: Watanabe Yasuyoshi,Oota Ryuuki,Takeda Consumer Healthcare Company Limited