UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060398 |
|---|---|
| Receipt number | R000069073 |
| Scientific Title | Investigation of Human Pharmacokinetics of [2-11C]acetate and Changes in brain uptake of acid acetate induced by neural activity and fatigue. |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2026/01/16 17:09:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of human pharmacokinetics of acetate and changes in brain uptake of acid acetate induced by neural activity and fatigue.
Acronym
Investigation of human pharmacokinetics of acetate and changes in brain uptake of acid acetate induced by neural activity and fatigue.
Scientific Title
Investigation of Human Pharmacokinetics of [2-11C]acetate and Changes in brain uptake of acid acetate induced by neural activity and fatigue.
Scientific Title:Acronym
Investigation of Human Pharmacokinetics of [2-11C]acetate and Changes in brain uptake of acid acetate induced by neural activity and fatigue.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize the pharmacokinetics of acetate in humans.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time-course quantitative measurements of [2-11C]acetate uptake in each organ and regions of interest, and changes in time-course quantitative [2-11C]acetate uptake in brain regions associated with task-related brain activity.
Key secondary outcomes
Temporal changes in [2-11C]acetate uptake in head muscles and cervicocranial tissues during rest and brain activation periods.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Administration of a PET tracer.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1. Aged 20 to under 65
2. A body weight of at least 50 kg but less than 85 kg, and a BMI of at least 18.5 but less than 26.5.
Key exclusion criteria
1.Individuals with serious diseases affecting organs such as the liver, kidneys, heart, blood, or blood vessels.
2.Individuals who have taken or used any medicinal products, quasi-drugs, or health foods (including dietary supplements) within 7 days prior to administration of the investigational product.
3.Individuals who habitually consume asetic acid beverages or supplements, or who have taken such beverages or supplements within 1 month prior to administration of the investigational product.
4.Individuals who are habitual heavy drinkers (20 g or more of pure alcohol per day) or who have engaged in excessive alcohol consumption (40 g or more per day) within the past 7 days.
5.Individuals who are current smokers.
6.Individuals with a history of drug allergy or food allergy.
7.Individuals who are currently participating in another clinical study, or who have participated in another clinical study in the past, and for whom less than 4 months have passed since the last administration of the investigational drug.
8. Individuals who have donated 200 mL or more of blood within the past 1 month, or 400 mL or more of blood within the past 3 months.
9.Individuals who have participated in another PET study within the past 1 year.
10.Individuals with drug dependence or alcohol dependence.
11.Individuals who have received a vaccine for influenza, COVID-19, or other vaccines within 2 weeks prior to administration of the investigational drug.
12.Individuals judged as inappropriate for participation by the principal investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yasuyoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Integrated Health Science Co., Ltd.
Division name
Research Division
Zip code
5300011
Address
JAM-OFFICE 5-D, JAM BASE, 5F, GRAND GREEN OSAKA North 6-38 Ofukacho, Kita-ku, Osaka, JAPAN
TEL
080-2466-6100
contact@integhs.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Watanabe |
Organization
Integrated Health Science Co., Ltd.
Division name
Research Division
Zip code
5300011
Address
JAM-OFFICE 5-D, JAM BASE, 5F, GRAND GREEN OSAKA North 6-38 Ofukacho, Kita-ku, Osaka, JAPAN
TEL
080-2466-6100
Homepage URL
contact@integhs.jp
Sponsor or person
Institute
Integrated Health Science Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu Medical Photonics Foundation Hamamatsu Medical Imaging Center Ethics Committee
Address
5000, Hirakuchi, Hamakita-ku, Hamamatsu City, Shizuoka Pref.
Tel
053-584-6411
pet@hmp.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 18 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069073
