Data suggests that imaging activity of the brain can measure the effects of anti-anxiety drugs. This study will investigate the effect of GW876008 on areas of the brain involved with thinking and emotion
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
26
GSK Investigational Site
La Jolla, California, United States
Differences in brain activation elicited by Matching Emotional Face Expression paradigm following single oral doses of GW876008 and lorazepam on day 1, sessions 1-4
GW876008 blood levels
Time frame: pre-dose & post-dose, sessions 1-4
clinical rating scales change after dosing: questionnaires collected
Time frame: pre-dose & up to 6-8 hours post-dose.
Safety: 12-lead ECG, vital signs, adverse events, clinical labs
fMRI BOLD neuroanatomical structure of the emotional brain neurocircuitry and connectivity
fMRI BOLD Signal characteristics and connectivity
fMRI BOLD Response in the emotional brain neurocircuitry and occipital cortex.
ETCo2 in mm Hg, to be recorded for the duration of the scan session and be synchronized with the single fMRI procedure timing
Visual Analog Scale (VAS) measurements of sleepiness, alertness, calm, tension, and anxiety performed before dosing (baseline), pre-fMRI session, post-fMRI session and just before leaving the facility.
Association between the anxiety trait (STAI-trait, test battery for neuroticism or liability for Anxiety Disorders) collected at screening and the various pharmacodynamic parameters measured in the various testing conditions.
GW876008 concentration to determine pharmacokinetic parameters to be collected twice per session,
Pharmacogenetic (PGx) assessments
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Safety and tolerability of GW876008 to include Vital signs semi-supine; respiratory rate, pulse oximetry and ECG.
Clinical laboratory tests
fMRI BOLD ALS signal.
Heart rate (HR; beats per minute), to be recorded for the whole duration of the scan session and to be synchronized with the single fMRI procedure timing.
Respiratory rate (RR: inspiration per minute), to be recorded for the duration of scan session and be synchronized with the single fMRI procedure timing. .