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

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.

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: AZD7325; Drug: AZD7325; Drug: AZD7325; Drug: Lorazepam; Drug: Lorazepam

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands
    • Centre for Human Drug Research

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; AZD7325 Placebo/Lorazepam Placebo combination therapy; washout period; AZD7325 10 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam 1 mg combination therapy; washout period; AZD7325 1 mg/Lorazepam Placebo combination therapy	Drug: AZD7325; AZD7325 10 mg oral 2 capsules; Drug: AZD7325; AZD7325 1 mg oral 2 capsules; Drug: AZD7325; AZD7325 Placebo oral 2 capsules; Drug: Lorazepam; Lorazepam 1 mg oral 2 tablets; Drug: Lorazepam; Lorazepam Placebo oral 2 tablets
Other: 2; AZD7325 10 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 1mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam 1 mg combination therapy	Drug: AZD7325; AZD7325 10 mg oral 2 capsules; Drug: AZD7325; AZD7325 1 mg oral 2 capsules; Drug: AZD7325; AZD7325 Placebo oral 2 capsules; Drug: Lorazepam; Lorazepam 1 mg oral 2 tablets; Drug: Lorazepam; Lorazepam Placebo oral 2 tablets
Other: 3; AZD7325 Placebo/Lorazepam 1 mg combination therapy; washout period; AZD7325 Placebo/Lorazepam Placebo combination therapy; washout period; AZD7325 1 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 10 mg/Lorazepam Placebo combination therapy	Drug: AZD7325; AZD7325 10 mg oral 2 capsules; Drug: AZD7325; AZD7325 1 mg oral 2 capsules; Drug: AZD7325; AZD7325 Placebo oral 2 capsules; Drug: Lorazepam; Lorazepam 1 mg oral 2 tablets; Drug: Lorazepam; Lorazepam Placebo oral 2 tablets
Other: 4; AZD7325 1 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam 1 mg combination therapy; washout period; AZD7325 10 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam Placebo combination therapy	Drug: AZD7325; AZD7325 10 mg oral 2 capsules; Drug: AZD7325; AZD7325 1 mg oral 2 capsules; Drug: AZD7325; AZD7325 Placebo oral 2 capsules; Drug: Lorazepam; Lorazepam 1 mg oral 2 tablets; Drug: Lorazepam; Lorazepam Placebo oral 2 tablets

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.	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.	Blood samples will be taken during the study.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: J.M.A. Van Gerven, MD, PhD, CHDR Leiden, the Netherlands

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: July 18, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Estimate): December 10, 2010
• Last Update Submitted That Met QC Criteria: December 8, 2010
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Phase I; pharmacodynamic study
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Lorazepam
• Other Study ID Numbers: D1140C00003; EudractCT 2008-001757-17