A Sedation/Cognition/EEG Study Using AZD6280 and Comparator

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00750802
First received: September 10, 2008
Last updated: June 25, 2009
Last verified: June 2009
  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 1

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014