A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers

Study Overview
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Brief Summary
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This study will be conducted in healthy volunteers to investigate the effect of single dose GSK561679 on the changes of brain activation, as it compares to an active comparator, lorazepam.

Official Title
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A Randomised, Placebo-controlled, Double-dummy, Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GSK561679 and Lorazepam (Comparator) in Healthy Subjects

Conditions
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Depressive Disorder and Anxiety Disorders

Intervention / Treatment
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* Drug: single dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males Non-smokers Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-29.9 kg/m2 Normal ECG. Exclusion Criteria: Any serious medical disorder or condition. Any history of an endocrine disorder. Any clinically significant laboratory abnormality. History of psychiatric illness. Any history of suicidal attempts or behavior. History or current diagnosis of acute narrow angle glaucoma. Left handed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo arm<br>There are single dose treatment arms of GSK561679, lorazepam as well as placebo. | Drug: single dose<br>* Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.<br>|
| Experimental: GSK561679 arm<br>There are single dose treatment arms of GSK561679, lorazepam as well as placebo. | Drug: single dose<br>* Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.<br>|
| Active Comparator: lorazepam arm<br>There are single dose treatment arms of GSK561679, lorazepam as well as placebo. | Drug: single dose<br>* Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in fMRI brain activation (BOLD) response in specific brain regions |  | conducted the duration of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiologic changes |  | during & after fMRI session | 
| Visual Analogue Scale measurement of physical reactions |  | duration of study | 
| Blood level of GSK561679 |  | collected during fMRI session | 
| Vital signs & ECG recording |  | duration of the study | 
| Lab tests for blood & urine |  | throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSK561679,, single,, dose,, lorazepam,, fMRI,, BOLD,, healthy volunteers