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A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
J.M.A. Van Gerven, MD, PhD, Principal Investigator, Affiliation: CHDR Leiden, the Netherlands


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: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.


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

Centre for Human Drug Research, Leiden, Netherlands
Additional Information

Starting date: June 2008
Last updated: December 8, 2010

Page last updated: August 23, 2015

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