A Sedation/Cognition/EEG Study Using AZD6280 and Comparator

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750802
• Other study ID #: D0850C00014
• Secondary ID: Eudract # 2008-0
• Status: Completed
• Phase: Phase 1
• First received: September 10, 2008
• Last updated: June 25, 2009
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• AZD6280
10mg Capsule, oral, single-dose
• AZD6280
40mg Capsule, oral, single-dose
• Lorazepam
2mg tablet, oral single-dose
• Placebo

Locations

Country	Name	City	State
Netherlands	Research Site	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests		Test batteries will be performed at specified times both before and following study drug administration	Yes
Secondary	Evaluation and characterization of the pharmacokinetics of AZD6280		Blood samples will be taken during the study.	No