- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01424384
Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic
July 5, 2017 updated by: GlaxoSmithKline
Emotional Processing in Healthy Male Volunteers Treated With GSK424887. A Single Centre, Randomised, Double-blind, Placebo-controlled Parallel Group Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oxford, United Kingdom, OX3 7JX
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Citalopram
Marketed comparitor
|
Neurophysiological testing.
|
EXPERIMENTAL: Investigational Medicinal Product
GSK424887
|
Neurophysiological testing
|
PLACEBO_COMPARATOR: Placebo To Match Treatment
Placebo control
|
Neurophysiological testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Multiple emotional and psychometric battery of tests
Time Frame: < 1 day
|
< 1 day
|
Adverse Events, laboratory values, vital signs, ECGs
Time Frame: < 1 day
|
< 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 19, 2008
Primary Completion (ACTUAL)
April 30, 2009
Study Completion (ACTUAL)
April 30, 2009
Study Registration Dates
First Submitted
February 12, 2010
First Submitted That Met QC Criteria
August 25, 2011
First Posted (ESTIMATE)
August 29, 2011
Study Record Updates
Last Update Posted (ACTUAL)
July 7, 2017
Last Update Submitted That Met QC Criteria
July 5, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Mood Disorders
- Depressive Disorder
- Anxiety Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- 105012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Study Protocol
Information identifier: 105012Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 105012Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotated Case Report Form
Information identifier: 105012Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 105012Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 105012Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: 105012Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 105012Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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