Status:
COMPLETED
Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder and Anxiety Disorders
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This will be a phase I, single centre, randomised, double blind, double-dummy, placebo controlled, parallel group single-dose study in healthy volunteers. The purpose of this study is to assess the ef...
Eligibility Criteria
Inclusion
- Healthy males with no neurological, or history of psychiatric illness
- Aged between 18 and 45 years
- Agree to use contraception
- BMI range of 18 to 33 kg/m²
- Fluent English speakers
- Non smoker or light smoker
Exclusion
- Positive pre-study drug/alcohol screen or regular alcohol consumption
- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- On prescription or non prescription drug
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Consumption of large amounts of caffeinated drinks
- Significant hearing impairment
- Previous experience of the emotional test battery experimental procedures
Key Trial Info
Start Date :
September 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2009
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01424384
Start Date
September 19 2008
End Date
April 30 2009
Last Update
July 7 2017
Active Locations (1)
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1
GSK Investigational Site
Oxford, United Kingdom, OX3 7JX