A Sedation/Cognition/EEG Study Using AZD6280 and Comparator

June 25, 2009 updated by: AstraZeneca

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

The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on sleepiness, concentration and brain activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: AZD6280
10mg Capsule, oral, single-dose
Drug: AZD6280
40mg Capsule, oral, single-dose
Experimental: 2
Drug: AZD6280
10mg Capsule, oral, single-dose
Drug: AZD6280
40mg Capsule, oral, single-dose
Placebo Comparator: 4
Drug: Placebo
Active Comparator: 3
Drug: Lorazepam
2mg tablet, oral single-dose
Other Names:
  • Ativan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests
Time Frame: Test batteries will be performed at specified times both before and following study drug administration
Test batteries will be performed at specified times both before and following study drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation and characterization of the pharmacokinetics of AZD6280
Time Frame: Blood samples will be taken during the study.
Blood samples will be taken during the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 10, 2008

First Submitted That Met QC Criteria

September 10, 2008

First Posted (Estimate)

September 11, 2008

Study Record Updates

Last Update Posted (Estimate)

June 26, 2009

Last Update Submitted That Met QC Criteria

June 25, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0850C00014
  • Eudract # 2008-001757-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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