A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator. - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00720421

Purpose

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	Intervention	Phase
Healthy Volunteer	Drug: AZD7325 Drug: Lorazepam	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Drug Information available for: Lorazepam

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluation and characterization of the pharmacokinetics of AZD6280. [ Time Frame: Blood samples will be taken during the study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	June 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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
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
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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720421

Locations

Netherlands
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

More Information

No publications provided

Responsible Party:	Mark Smith, MD, Medical Science Director, Emerging Psychiatry, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00720421 History of Changes
Other Study ID Numbers:	D1140C00003, EudractCT 2008-001757-17
Study First Received:	July 18, 2008
Last Updated:	December 8, 2010
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

Phase I
pharmacodynamic study

Additional relevant MeSH terms:

Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents

Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012