A Sedation/Cognition/EEG Study Using AZD6280 and Comparator - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00750802

Purpose

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

Condition	Intervention	Phase
Healthy Volunteer	Drug: AZD6280 Drug: Lorazepam Drug: Placebo	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 AZD6280 on Sedation, Cognition and 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 ]

Enrollment:	17
Study Start Date:	September 2008
Study Completion Date:	December 2008

Arms	Assigned Interventions
Experimental: 1	Drug: AZD6280 10mg Capsule, oral, single-dose
Experimental: 2	Drug: AZD6280 40mg Capsule, oral, single-dose
Active Comparator: 3	Drug: Lorazepam 2mg tablet, oral single-dose Other Name: Ativan
Placebo Comparator: 4	Drug: Placebo

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750802

Locations

Netherlands
Research Site
Leiden, Netherlands

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	Mark Smith, MD, MSD, Emerging Psychiatry, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00750802 History of Changes
Other Study ID Numbers:	D0850C00014, Eudract # 2008-001757-17
Study First Received:	September 10, 2008
Last Updated:	June 25, 2009
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Phase I

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