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Home > Protocol Summaries: Compounds > GSK424887 > Protocol Summary for 105012

Protocol Summary for 105012

Protocol Summary
Protocol Id: 105012
Secondary Ids:
  • N/A
Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study
Phase: phase 1
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • United Kingdom: Medicines and Healthcare products Regulatory Agency
Collaborators:
  • N/A
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.
Detailed Description:
Record Verification Date: August 2011
Status: Completed
Why Study Stopped:
Study Start Date: September 2008
Study Completion Date: April 2009
Study Completion Date Type: Actual
Primary Completion Date: April 2009
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: yes
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Multiple emotional and psychometric battery of tests < 1 day
  • Adverse Events, laboratory values, vital signs, ECGs < 1 day
Secondary Outcomes:
Conditions:
  • Depressive Disorder and Anxiety Disorders
Keywords:
  • healthy volunteers
  • Anxiety Disorder
  • neuropsychological tests
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Male
Minimum Age: 18 Year
Maximum Age: 45 Year
Enrollment: 54
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information