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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00720421

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: AZD7325 Drug: AZD7325 Drug: AZD7325 Drug: Lorazepam Drug: Lorazepam	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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 AZD7325 on Sedation, Cognition and Electroencephalogram (EEG) in Comparison With Lorazepam in Healthy Male Volunteers.

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Evaluation and characterization of the pharmacokinetics of AZD6280. [Blood samples will be taken during the study.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Human Drug Research	Leiden		Netherlands

Sponsors and Collaborators

AstraZeneca

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00720421

Other Study ID Numbers:

D1140C00003
EudractCT 2008-001757-17

First Posted:

Jul 22, 2008

Last Update Posted:

Dec 10, 2010

Last Verified:

Nov 1, 2008

Keywords provided by , ,

Phase I

pharmacodynamic study

Additional relevant MeSH terms:

Lorazepam

Study Results

No Results Posted as of Dec 10, 2010