A Sedation/Cognition/EEG Study Using AZD6280 and Comparator
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: AZD6280 (Drug); AZD6280 (Drug); Lorazepam (Drug); Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Summary
The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on
sleepiness, concentration and brain activity.
Clinical Details
Official title: A Phase 1, Single Centre, Single Dose, Double-Blind, Double-Dummy, Four-Way Crossover, Placebo-Controlled, Randomized Study to Investigate the Effects of AZD6280 on Sedation, Cognition and EEG in Comparison With Lorazepam in Healthy Male Volunteers
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacodynamics Study
Primary outcome: Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests
Secondary outcome: Evaluation and characterization of the pharmacokinetics of AZD6280
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy male and female subjects aged 18 to 55 years (inclusive) on Day 1.
- Female subjects must be of non-child bearing potential.
Exclusion Criteria:
- 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
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Leiden, Netherlands; Recruiting
Additional Information
Starting date: September 2008
Ending date: January 2009
Last updated: September 10, 2008
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