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Completed

NCT Number: NCT00720421

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

The purpose of the study is to determine the effects of the compound AZD7325 as compared to lorazepam on sleepiness, concentration and brain activity.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research

Leiden, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD7325

Drug

AZD7325 10 mg oral 2 capsules

Lorazepam

Drug

Lorazepam 1 mg oral 2 tablets

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evaluation and characterization of the pharmacokinetics of AZD6280.

    Time frame: Blood samples will be taken during the study.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 22, 2008
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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