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van CCT (UK)

van CCT (UK)

Biodistribution of [11C]laniquidar in healthy volunteers.

- candidate number8454
- NTR NumberNTR2513
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-sep-2010
- Secondary IDs10186 METC VUmc
- Public TitleBiodistribution of [11C]laniquidar in healthy volunteers.
- Scientific TitleBiodistribution and dosimetry of the newly developed P-gp PET tracer [11C]laniquidar in healthy volunteers.
- hypothesisWhole body radiation of 370MBq [11C]laniquidar is approximately 2mSv.
- Healt Condition(s) or Problem(s) studiedHealthy subjects, Dosimetry, Biodistribution
- Inclusion criteria1. Age between 18-65 years;
2. Good physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests;
3. Written informed consent of each subject.
- Exclusion criteria1. 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;
3. Major psychiatric or neurological disorder;
4. History of alcohol and/or drug abuse (DSM-IV criteria);
5. History of coagulation problems;
6. Any sign of cardiovascular disease;
7. Current use of any medication, other than contraceptive medication;
8. Breast feeding;
9. Pregnancy;
10. Unable to understand or read the Dutch language.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-okt-2010
- planned closingdate1-mei-2011
- Target number of participants6
- Interventions1x[ 11C]Laniquidar whole-body PET-low-dose CT scan.
A low-dose whole-body CT scan is performed after which a single dose of 370MBq [11C]Laniquidar is venously injected. At the same time a whole-body PET scan is repeated during 1 hour.
- Primary outcomeBiodistribution and dosimetry of [11C]Laniquidar in healthy volunteers.
- Secondary outcomeMetabolic profile of [11C]Laniquidar in humans.
- TimepointsN/A
- Trial web sitehttp:/
- statusplanned
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryResistance to current drug therapy is an issue for approximately 30% of all people who develop epilepsy. Consequently, there is a pressing need to develop new and more effective treatments. P-glycoprotein (P-gp) seems to be involved in drug resistance. P-gp is an efflux transporter, which is located at the blood-brain barrier (BBB) and transports substrates (including multiple CNS drugs) from brain to blood and cerebrospinal fluid. Overexpression of P-gp is thought to be an important mechanism of pharmacoresistance in epilepsy. Availability of non-invasive imaging methods that would allow for an assessment of distribution and function of P-gp in the brain is of vital importance. Novel PET probes, designed to specifically measure P-gp expression, need to be developed. Laniquidar is an antagonist of P-gp and therefore it should bind in a dose dependent manner. Recently, this compound was labelled with carbon-11, making it a potential tool for measuring P-gp expression. Initial results of brain uptake of [11C]laniquidar in rats were inconclusive. The rat biodistribution studies in peripheral organs showed the highest uptake in the spleen, heart, kidney and lung. This might be due to the formation of labelled metabolites. Based on these biodistribution studies, the expected dose for a standard 370 Mega Becquerel (MBq) injection would be 1.85mSv (0.005mSv/MBq), well below the accepted safety limit for human studies. Nevertheless, only direct studies in humans can be used to determine the optimal (safe) dose of [11C]laniquidar. One condition for human use is that, in general, an injected dose of around 370 MBq is needed to allow for accurate measurements of plasma and tissue kinetics.
- Main changes (audit trail)
- RECORD15-sep-2010 - 3-okt-2010

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