MedDataX Logo

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

NCT ID: NCT00720421

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Phase I pharmacodynamic study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

AZD7325

Intervention Type DRUG

AZD7325 10 mg oral 2 capsules

AZD7325

Intervention Type DRUG

AZD7325 1 mg oral 2 capsules

AZD7325

Intervention Type DRUG

AZD7325 Placebo oral 2 capsules

Lorazepam

Intervention Type DRUG

Lorazepam 1 mg oral 2 tablets

Lorazepam

Intervention Type DRUG

Lorazepam Placebo oral 2 tablets

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

Group Type OTHER

AZD7325

Intervention Type DRUG

AZD7325 10 mg oral 2 capsules

AZD7325

Intervention Type DRUG

AZD7325 1 mg oral 2 capsules

AZD7325

Intervention Type DRUG

AZD7325 Placebo oral 2 capsules

Lorazepam

Intervention Type DRUG

Lorazepam 1 mg oral 2 tablets

Lorazepam

Intervention Type DRUG

Lorazepam Placebo oral 2 tablets

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

Group Type OTHER

AZD7325

Intervention Type DRUG

AZD7325 10 mg oral 2 capsules

AZD7325

Intervention Type DRUG

AZD7325 1 mg oral 2 capsules

AZD7325

Intervention Type DRUG

AZD7325 Placebo oral 2 capsules

Lorazepam

Intervention Type DRUG

Lorazepam 1 mg oral 2 tablets

Lorazepam

Intervention Type DRUG

Lorazepam Placebo oral 2 tablets

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

Group Type OTHER

AZD7325

Intervention Type DRUG

AZD7325 10 mg oral 2 capsules

AZD7325

Intervention Type DRUG

AZD7325 1 mg oral 2 capsules

AZD7325

Intervention Type DRUG

AZD7325 Placebo oral 2 capsules

Lorazepam

Intervention Type DRUG

Lorazepam 1 mg oral 2 tablets

Lorazepam

Intervention Type DRUG

Lorazepam Placebo oral 2 tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD7325

AZD7325 10 mg oral 2 capsules

Intervention Type DRUG

AZD7325

AZD7325 1 mg oral 2 capsules

Intervention Type DRUG

AZD7325

AZD7325 Placebo oral 2 capsules

Intervention Type DRUG

Lorazepam

Lorazepam 1 mg oral 2 tablets

Intervention Type DRUG

Lorazepam

Lorazepam Placebo oral 2 tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca Pharmaceuticals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

J.M.A. Van Gerven, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHDR Leiden, the Netherlands

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre for Human Drug Research

Leiden, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudractCT 2008-001757-17

Identifier Type: -

Identifier Source: secondary_id

D1140C00003

Identifier Type: -

Identifier Source: org_study_id