Healthy Volunteers Clinical Trial
Official title:
Cerebral Pharmacodynamic Effects of 5-HT1B Receptor Stimulation
The purpose of this study is to show that PET-MR imaging can be used for obtaining a pharmacodynamic profile of drugs. By using the 5-HT1B receptor as target we also aim to find effect areas and sizes of the 5-HT1B receptor agonist sumatriptan.
Recent technological advances in multimodal imaging have enabled the simultaneous acquisition
of magnetic resonance imaging (MRI) and PET data. Whereas functional MRI (fMRI) provides
excellent spatio-temporal resolution for localizing changes in brain activity, PET offers
high sensitivity and neurochemical specificity. Together, PET and MRI measures have the
potential to help clarify the neurochemical basis of changes in fMRI signal induced by
selective exogenous ligands or endogenous neurotransmitter.
In the present study we will target the 5-HT1B receptor for which a selective radioligand
exist (11C-AZ10419369). The receptor can be stimulated with the agonist sumatriptan, which is
used for alleviating migraine attacks. The mechanism of action of sumatriptan is not
precisely known and it is unknown to what degree sumatriptan crosses the blood-brain barrier
and exerts its effect in the parenchyma. In this study we can determine the blood brain
barrier penetration of sumatriptan and thereby evaluate Effect sizes, distribution of signal
changes, and correlation between the occupancy at the 5-HT1B receptor in the parenchyma
(measured by changes in BPND) and the hemodynamic response (measured by changes in CBF).
Ahead of the main study a pilot study will be conducted in which increasing doses of
sumatriptan will be tested in the same subject to obtain a dose-response curve. At the same
time side effects will be observed and scored. This serves to find the dose with maximum
effect size but minimal side effects, which can then be used in the main study for all
subjects.
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