Status:
COMPLETED
A Sedation/Cognition/EEG Study Using AZD6280 and Comparator
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on sleepiness, concentration and brain activity.
Eligibility Criteria
Inclusion
- Healthy male and female subjects aged 18 to 55 years (inclusive) on Day 1.
- Female subjects must be of non-child bearing potential.
Exclusion
- Clinically significant illness within 2 weeks before the study start.
- Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
- Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
- Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00750802
Start Date
September 1 2008
End Date
December 1 2008
Last Update
June 26 2009
Active Locations (1)
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1
Research Site
Leiden, Netherlands