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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01424384

Collaborator

(none)

Enrollment

Location

Arms

7.3

Actual Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder and Anxiety Disorders	Drug: Citalopram Drug: GSK424887 Drug: Plactebo To Match	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 19, 2008

Actual Primary Completion Date :

Apr 30, 2009

Actual Study Completion Date :

Apr 30, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Citalopram Marketed comparitor	Drug: Citalopram Neurophysiological testing.
Experimental: Investigational Medicinal Product GSK424887	Drug: GSK424887 Neurophysiological testing
Placebo Comparator: Placebo To Match Treatment Placebo control	Drug: Plactebo To Match Neurophysiological testing

Arm

Intervention/Treatment

Active Comparator: Citalopram

Marketed comparitor

Drug: Citalopram

Neurophysiological testing.

Experimental: Investigational Medicinal Product

GSK424887

Drug: GSK424887

Neurophysiological testing

Placebo Comparator: Placebo To Match Treatment

Placebo control

Drug: Plactebo To Match

Neurophysiological testing

Outcome Measures

Primary Outcome Measures

Multiple emotional and psychometric battery of tests [< 1 day]
Adverse Events, laboratory values, vital signs, ECGs [< 1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy males with no neurological, or history of psychiatric illness
Aged between 18 and 45 years
Agree to use contraception
BMI range of 18 to 33 kg/m²
Fluent English speakers
Non smoker or light smoker

Exclusion Criteria:

Positive pre-study drug/alcohol screen or regular alcohol consumption
Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
On prescription or non prescription drug
Exposure to more than four new chemical entities within 12 months prior to the first dosing day
Consumption of large amounts of caffeinated drinks
Significant hearing impairment
Previous experience of the emotional test battery experimental procedures