Test-retest of the newly developed P-gp PET tracer [11C]laniquidar in healthy volunteers
- Conditions
- geen (nu nog in gezonde mensen)not applicable
- Registration Number
- NL-OMON36016
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
- Age between 18-65 years
- Good physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests
- Weight >50 kg
- RDC diagnosis never mentally ill
- Written informed consent of each subject
- Any clinical significant abnormality of any clinical laboratory test - 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 - Major psychiatric or neurological disorder - History of alcohol and/or drug abuse (DSM-IV criteria) - History of coagulation problems - Any sign of cardiovascular disease - Current use of any medication, other than contraceptive medication - Breast feeding - Pregnancy - Unable to understand or read the Dutch language
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>(1) To assess [11C]laniquidar plasma and brain kinetics in healthy<br /><br>volunteer(s), including assessment of the presence of radioactive metabolites<br /><br>in plasma. (2) To determine intra-subject variation of [11C]laniquidar kinetics<br /><br>in humans.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To develop a tracer kinetic model for [11C]laniquidar in humans. </p><br>