Healthy Clinical Trial
Official title:
Pupillary Changes as a Potential Biomarker for Escitalopram in Relation to CYP2C19 Polymorphism
To study the impact of CYP2C19 polymorphism on escitalopram pharmacokinetics and pharmacodynamics measured as changes in pupil diameter
Escitalopram, the therapeutic active S-enantiomer of citalopram, is a selective serotonine
reuptake inhibitor (SSRI) used for treatment of depression and anxiety disorders. The
antidepressant effect is probably due to a stimulation of the serotonergic neurotransmission
caused by the inhibition of the presynaptic serotonin reuptake. This inhibition may also be
responsible for the increased pupil diameter seen in volunteers treated with racemic
citalopram. Based on escitaloprams pharmacodynamic properties it is expected to have the
same affect on pupil diameter. A dose/response relationship has not yet been established but
theoretically the pupillary changes might serve as a biomarker for the serotonergic effect
of escitalopram.
Escitalopram is demethylated in part by the polymorphic cytochrome P450 enzyme 2C19
(CYP2C19); but the impact of CYP2C19 polymorphism on the total metabolism of escitalopram is
still to be investigated.
Objective: The aim of this study is to investigate the pharmacokinetics and pharmacodynamics
in CYP2C19 extensive metabolizers (EMs) and poor metabolizers (PMs) and to investigate
whether change in pupil size reaction to a light stimulus can act as a biomarker for the
serotonergic effect of escitalopram.
The study will be conducted as a randomized, double blinded; placebo controlled two phases
cross-over trial with single and repeated doses of 20 mg escitalopram and equivalent
placebo. Sixteen healthy volunteers (8 EMs and 8 PMs) will participate in the trial. Prior
to the trial, approximately 400 volunteers will be phenotyped by omeprazole metabolic ratio
in order to identify the CYP2C19 EMs and PMs.
During the two phases blood samples will be drawn and pupil sizes will be measured at fixed
time points after drug administration.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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