Imaging Study to Compare Effects of Darolutamide and Enzalutamide With Respect to Placebo on the Blood Flow in the Brain in Healthy Male Volunteers.
Not yet recruiting
The current study will investigate the effects of a single dose of darolutamide and
enzalutamide compared with placebo and compared to each other on human brain blood flow using
arterial spin labeling magnetic resonance imaging (ASL-MRI), a non-invasive MRI technique.
The change in cerebral blood flow is an indirect measure of brain penetration.
The risk of drug-associated CNS-related adverse events is likely to be correlated with the
concentration of the drug in the brain. In contrast to enzalutamide, preclinical studies of
darolutamide indicate that its brain penetration is much lower.
The aim of this study is to determine whether there is a difference between darolutamide and
enzalutamide compared to placebo in cerebral blood flow and thus in brain penetration.
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