A Study to Investigate the Effects of GW876008 on Brain Activation During Emotional Processing in Healthy Subjects.
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|ClinicalTrials.gov Identifier: NCT00424697|
Recruitment Status : Completed
First Posted : January 19, 2007
Last Update Posted : October 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Drug: placebo Drug: lorazepam Drug: GW876008||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Randomized, Placebo-controlled, Double-dummy, Four-way Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GW876008 and Lorazepam (Comparator) in Healthy Subjects.|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- Drug: placebo
- Drug: lorazepam
- Drug: GW876008
- 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
- 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. .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424697
|United States, California|
|GSK Investigational Site|
|La Jolla, California, United States, 92093|
|Study Director:||GSK Clinical Trials, MBChB, MFPM||GlaxoSmithKline|