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

Tracking Information

First Received Date ^ICMJE

August 6, 2007

Last Updated Date

August 6, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00513565 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacodynamics Study

Condition ^ICMJE

Healthy Subjects

Intervention ^ICMJE

Drug: single dose

Study Arms / Comparison Groups

Active Comparator: There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Placebo Comparator: There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Experimental: There are single dose treatment arms of GSK561679, lorazepam as well as placebo.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00513565

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

CRS 105510

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP