A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers
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
1 other identifier
interventional
22
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2007
CompletedFirst Posted
Study publicly available on registry
August 8, 2007
CompletedStudy Start
First participant enrolled
September 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2009
CompletedJuly 21, 2017
July 1, 2017
1.7 years
August 6, 2007
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences in fMRI brain activation (BOLD) response in specific brain regions
conducted the duration of the study
Secondary Outcomes (5)
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
Study Arms (3)
placebo arm
PLACEBO COMPARATORThere are single dose treatment arms of GSK561679, lorazepam as well as placebo.
GSK561679 arm
EXPERIMENTALThere are single dose treatment arms of GSK561679, lorazepam as well as placebo.
lorazepam arm
ACTIVE COMPARATORThere are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Interventions
Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
Eligibility Criteria
You may qualify if:
- Healthy males
- Non-smokers
- Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-29.9 kg/m2
- Normal ECG.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
La Jolla, California, 92037, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2007
First Posted
August 8, 2007
Study Start
September 13, 2007
Primary Completion
May 14, 2009
Study Completion
May 14, 2009
Last Updated
July 21, 2017
Record last verified: 2017-07