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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00513565

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects	Drug: single dose	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacodynamics Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Lorazepam

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Differences in fMRI brain activation (BOLD) response in specific brain regions [ Time Frame: conducted the duration of the study ]

Secondary Outcome Measures:

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

Enrollment:	22
Study Start Date:	September 2007
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
lorazepam arm: Active Comparator There are single dose treatment arms of GSK561679, lorazepam as well as placebo.	Drug: single dose Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
placebo arm: Placebo Comparator There are single dose treatment arms of GSK561679, lorazepam as well as placebo.	Drug: single dose Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
GSK561679 arm: Experimental There are single dose treatment arms of GSK561679, lorazepam as well as placebo.	Drug: single dose Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513565

Locations

United States, California
GSK Investigational Site
La Jolla, California, United States, 92037

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CRS 105510
Study First Received:	August 6, 2007
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00513565 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

fMRI,
BOLD,
single,
dose,

GSK561679,
lorazepam,
healthy volunteers

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Pharmacologic Actions

Lorazepam
Autonomic Agents
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 05, 2009