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A Sedation/Cognition/EEG Study Using AZD6280 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: AZD6280 (Drug); AZD6280 (Drug); Lorazepam (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

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: 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

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

Research Site, Leiden, Netherlands
Additional Information

Starting date: September 2008
Last updated: June 25, 2009

Page last updated: August 23, 2015

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