Biodistribution and dosimetry 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-OMON35158
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
- Age between 18-65 years
- Good physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests
- 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) Biodistribution of [11C]laniquidar in healthy humans;<br /><br>(2) Effective radiation dose of [11C]laniquidar in humans;</p><br>
- Secondary Outcome Measures
Name Time Method <p>Metabolic profile of [11C]laniquidar in humans.</p><br>