NCT01424384

Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic

Emotional Processing in Healthy Male Volunteers Treated With GSK424887. A Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Depressive Disorder and Anxiety Disorders

Interventions

Type	Name	Description
DRUG	Citalopram	Neurophysiological testing.
DRUG	GSK424887	Neurophysiological testing
DRUG	Plactebo To Match	Neurophysiological testing

Timeline

• Start date: 2008-09-19
• Primary completion: 2009-04-30
• Completion: 2009-04-30
• First posted: 2011-08-29
• Last updated: 2017-07-07

Locations

1 site across 1 country: United Kingdom