Onderzoek ter evaluatie van de test -retest variatie van [11C]fenytoine in gezonde vrijwilligers.
- Conditions
- - pharmacoresistant epilepsy- Blood Brain Barrier (BBB)- upregulation of multidrug efflux transporters (e.g. P-gp)- brain pharmacokinetics
- Registration Number
- NL-OMON24061
- Lead Sponsor
- Prof. A.A. Lammertsma, PhDHead of the Department of Nuclear Medicine & PET researchVU University Medical CentreDe Boelelaan 11171007 MB AmsterdamT +31204444214F +31204443090E-mail: aa.lammertsma@vumc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
1. Age between 18-65 years;
2. Good physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests;
Exclusion Criteria
1. Any clinical significant abnormality of any clinical laboratory test;
2. Any subject who has received any investigational medication within 30 days prior to the start of this study, or who is scheduled to receive an investigational drug;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Plasma kinetics of [11C]phenytoin in humans, including assessment of the presence of radioactive metabolites;<br /><br>2. Brain kinetics of [11C]phenytoin in humans;<br /><br>3. Determination of the most accurate tracer kinetic model for [11C]phenytoin in humans;<br /><br>4. Determination of the most suitable parametric method for [11C]phenytoin in humans;<br /><br>5. Assessment of inter- and intra-subject variation of [11C]phenytoin kinetics in humans.
- Secondary Outcome Measures
Name Time Method