Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic
Status:
Completed
Trial end date:
2009-04-30
Target enrollment:
Participant gender:
Summary
This will be a phase I, single centre, randomised, double blind, double-dummy, placebo
controlled, parallel group single-dose study in healthy volunteers. The purpose of this study
is to assess the effect of a single-dose administration of GSK424887, a potent, selective
competitive antagonist of the human Neurokinin 1 (NK1) receptor and a potent inhibitor of the
human serotonin transporter (SERT), at the maximum dosage of 100 mg versus placebo and versus
citalopram (20 mg) on emotional processing in healthy male volunteers. Pharmacokinetics and
safety following oral administration of GSK424887 will be also evaluated. An Emotional Test
Battery (ETB) previously used to characterise the effects of antidepressants on positive and
negative emotion processing in Healthy Volunteers and patients will be used. We hypothesise
that GSK424887 will modulate emotional information processing acutely. We anticipate that
these effects may be manifest at sub-effective levels of NK1 and SERT receptor occupancy,
thus providing pharmacodynamic evidence of the synergistic interaction of the two mechanisms
in humans.