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

Overview[ - collapse ][ - ]

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.
ConditionHealthy Volunteer
InterventionDrug: AZD7325
Drug: AZD7325
Drug: AZD7325
Drug: Lorazepam
Drug: Lorazepam
PhasePhase 1
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT00720421
First ReceivedJuly 18, 2008
Last UpdatedDecember 8, 2010
Last verifiedNovember 2008

Tracking Information[ + expand ][ + ]

First Received DateJuly 18, 2008
Last Updated DateDecember 8, 2010
Start DateJune 2008
Estimated Primary Completion DateAugust 2008
Current Primary Outcome MeasuresEvaluation 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]
Current Secondary Outcome MeasuresEvaluation and characterization of the pharmacokinetics of AZD6280. [Time Frame: Blood samples will be taken during the study.] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.
Official TitleA 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.
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
ConditionHealthy Volunteer
InterventionDrug: 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
Study Arm (s)
  • 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
  • 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
  • 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
  • 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

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment16
Estimated Completion DateAugust 2008
Estimated Primary Completion DateAugust 2008
Eligibility 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
GenderMale
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesNetherlands

Administrative Information[ + expand ][ + ]

NCT Number NCT00720421
Other Study ID NumbersD1140C00003
Has Data Monitoring CommitteeNo
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsNot Provided
Investigators Principal Investigator: J.M.A. Van Gerven, MD, PhD CHDR Leiden, the Netherlands
Verification DateNovember 2008

Locations[ + expand ][ + ]

Centre for Human Drug Research
Leiden, Netherlands