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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Depressive Disorder and Anxiety Disorders

Treatments: Drug: single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00513565

CRS105510

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 3 patient groups, including a placebo group

placebo arm

Placebo Comparator group

Description:

There are single dose treatment arms of GSK561679, lorazepam as well as placebo.

Treatment:

Drug: single dose

GSK561679 arm

Experimental group

Description:

There are single dose treatment arms of GSK561679, lorazepam as well as placebo.

Treatment:

Drug: single dose

lorazepam arm

Active Comparator group

Description:

There are single dose treatment arms of GSK561679, lorazepam as well as placebo.

Treatment:

Drug: single dose