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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00513565

Enrollment

Registered

2007-08-08

Start date

2007-09-13

Completion date

2009-05-14

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder and Anxiety Disorders

Keywords

GSK561679,, single,, dose,, lorazepam,, fMRI,, BOLD,, healthy volunteers

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.

Interventions

DRUGsingle dose

Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Differences in fMRI brain activation (BOLD) response in specific brain regions	conducted the duration of the study

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026