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OpenTrials
Completed

NCT Number: NCT01424384

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

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.

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Key information

Conditions

Depressive Disorder and Anxiety Disorders Anxiety Disorders Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Oxford, OX3 7JX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citalopram

Drug

Neurophysiological testing.

GSK424887

Drug

Neurophysiological testing

Plactebo To Match

Drug

Neurophysiological testing

Primary outcomes

  1. Multiple emotional and psychometric battery of tests

    Time frame: < 1 day

  2. Adverse Events, laboratory values, vital signs, ECGs

    Time frame: < 1 day

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 29, 2011
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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