Last updated: 11/07/2018 01:02:28

Emotional processing in healthy volunteers in the presence of an investigational anxiolytic

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GSK study ID
105012
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Clinicaltrials.gov ID
NCT01424384
EudraCT ID
2007-007807-34
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Multiple emotional and psychometric battery of tests

Timeframe: < 1 day

Adverse Events, laboratory values, vital signs, ECGs

Timeframe: < 1 day

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Citalopram
  • Drug: GSK424887
  • Drug: Plactebo To Match
    • Enrollment:
    54
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Catherine J Harmer, Gerry Dawson, Colin Dourish, Elisa Favaron, Lizzie Parsons, Chloe Destoppeleire-Adida, Monica Fiore, Mauro Zucchetto, Angelo Bifone, Italo Poggesi, Sofia Fernandes, Bob Alexander and Guy M Goodwin. Combined NK1 antagonism and serotonin reuptake inhibition: effects on emotional processing in humans. J Psychopharmacol. 2013;27(5):435-443.
    Medical condition
    Depressive Disorder and Anxiety Disorders
    Product
    GSK424887
    Collaborators
    Not applicable
    Study date(s)
    September 2008 to April 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • 1. Healthy males with no neurological, or history of psychiatric illness
    • 2. Aged between 18 and 45 years
    • 1. Positive pre-study drug/alcohol screen or regular alcohol consumption
    • 2. Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 1. Healthy males with no neurological, or history of psychiatric illness 2. Aged between 18 and 45 years 3. Agree to use contraception 4. BMI range of 18 to 33 kg/m² 5. Fluent English speakers 6. Non smoker or light smoker
    Exclusion criteria:
    • 1. Positive pre-study drug/alcohol screen or regular alcohol consumption 2. Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening 3. On prescription or non prescription drug 4. Exposure to more than four new chemical entities within 12 months prior to the first dosing day 5. Consumption of large amounts of caffeinated drinks 6. Significant hearing impairment 7. Previous experience of the emotional test battery experimental procedures

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Oxford, United Kingdom, OX3 7JX
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2009-30-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
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