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Completed

NCT Number: NCT00750802

A Sedation/Cognition/EEG Study Using AZD6280 and Comparator

The purpose of the study is to determine the effects of AZD6280 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

Research Site

Leiden, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

AZD6280

Drug

10mg Capsule, oral, single-dose

Lorazepam

Drug

2mg tablet, oral single-dose

Other names: Ativan

Placebo

Drug

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.

Interested in participating?

Completed

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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 AZD6280 on Sedation, Cognition and EEG in Comparison With Lorazepam in Healthy Male Volunteers

Important dates

Study start
2008
Study completion
2008
First posted
Sep 11, 2008
Registry last updated
Jun 26, 2009

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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