A Sedation/Cognition/EEG Study Using AZD6280 and Comparator

NCT ID: NCT00750802

Last Updated: 2009-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

AZD6280

Intervention Type DRUG

10mg Capsule, oral, single-dose

2

Group Type EXPERIMENTAL

AZD6280

Intervention Type DRUG

40mg Capsule, oral, single-dose

3

Group Type ACTIVE_COMPARATOR

Lorazepam

Intervention Type DRUG

2mg tablet, oral single-dose

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD6280

10mg Capsule, oral, single-dose

Intervention Type DRUG

AZD6280

40mg Capsule, oral, single-dose

Intervention Type DRUG

Lorazepam

2mg tablet, oral single-dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Ativan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Locations

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Research Site

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Eudract # 2008-001757-17

Identifier Type: -

Identifier Source: secondary_id

D0850C00014

Identifier Type: -

Identifier Source: org_study_id

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