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

Condition(s) targeted: Healthy Subjects

Intervention: GSK561679 and Lorazepam (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

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.

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

Study design: Diagnostic, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study

Primary outcome: Differences in fMRI brain activation (BOLD) response in specific brain regions

Secondary outcome:

Physiologic changes

Visual Analogue Scale measurement of physical reactions

Blood level of GSK561679

Vital signs & ECG recording

Lab tests for blood & urine

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

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

US GSK Clinical Trials Call Center, Phone: 877-379-3718

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

Starting date: September 2007
Last updated: October 15, 2008