First-in-human study of [18F]MC225
- Conditions
- ormal subjects
- Registration Number
- JPRN-jRCTs031190136
- Lead Sponsor
- Ishii Kenji
- Brief Summary
As a result of initial clinical evaluation of 8 healthy males, [18F] MC225 was pharmacologically safe at a dose that can be imaged with PET, and the radiation exposure dose was within the allowable range.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 9
The following criteria must be met by ALL Subjects:
1. Male subjects aged between 20 and 60 years at the informed consent
2. Subjects who provide written informed consent.
Subjects who have any of the following present or past history of illness:
1. Past history of neuropsychiatric disorders such as epilepsy, major depression, or schizophrenia
2. Subjects who are currently taking prescription drugs, general pharmaceuticals, quasi-drugs, and health food products (suppliments)
3. Smorkers
4. Subjects who drink alcohol the day before or the day of the visit
5. Subjects who have contraindication of or being inadicuate for MRI
6. Subjects who have past history of severe drug hypersensitivity
7. Subjects who have past history of cardiovascular diseases
8. Subjects who are currently suffering from chronic anemia, chronic renal failure, or any other significant diseases
9. Subjects who are judged as ineligible for the study by the principal investigator
Study & Design
- Study Type
- Other
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Human radiation dosimetry of [18F]MC225<br>2. Safty of intravenous administration of [18F]MC225<br>3. Pharmakokinetics of [18F]MC225 (metabolism, blood clearance, urine extraction rate)
- Secondary Outcome Measures
Name Time Method 1. Optimization of data acquisition methods and scanning protocol<br>2. Establishment of quantification<br>3. Building appropriate methods for image evaluation and analysis