Distribution of [11C]ubiquinol-10 in various human tissues

JRCT ID: jRCTs051220018

Registered date:28/04/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: healthy volunteer
• Date of first enrollment: 07/06/2022
• Target sample size: 16
• Study type: Interventional
• Intervention(s): 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 with the activity of approximately 100 MBq

Outcome(s)

Primary Outcome

1) Difference of laboratory values
2) Systemic distribution of study drug and accumulation in each organ
3) Whole-body and organ dosimetry

Secondary Outcome

Pharmacokinetics of the head, liver, kidneys, Splee
n, and other parts where the amount of accumulat
ion was higher than other parts

Key inclusion & exclusion criteria

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

Include 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.

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 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

Related Information

• Primary Sponsor: Morita Naomi
• Secondary Sponsor: Watanabe Yasuyoshi
• Source(s) of Monetary Support: KANEKA CORPORATION