A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: AZD7325 (Drug); AZD7325 (Drug); AZD7325 (Drug); Lorazepam (Drug); Lorazepam (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
J.M.A. Van Gerven, MD, PhD, Principal Investigator, Affiliation: CHDR Leiden, the Netherlands
Overall contact:
AstraZeneca, United States Clinical Study Information, Phone: 800 236 9933, Email: information.center@astrazeneca.com
Summary
The purpose of the study is to determine the effects of the compound AZD7325 as 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 AZD7325 on Sedation, Cognition and Electroencephalogram (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 aged 18 to 55 years on screening
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, United States Clinical Study Information, Phone: 800 236 9933, Email: information.center@astrazeneca.com
Centre for Human Drug Research, Leiden, Netherlands; Recruiting
Additional Information
Starting date: June 2008
Ending date: August 2008
Last updated: July 18, 2008
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