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. |
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Condition | Healthy Volunteer |
Intervention | Drug: AZD7325 Drug: AZD7325 Drug: AZD7325 Drug: Lorazepam Drug: Lorazepam |
Phase | Phase 1 |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT00720421 |
First Received | July 18, 2008 |
Last Updated | December 8, 2010 |
Last verified | November 2008 |
Tracking Information[ + expand ][ + ]
First Received Date | July 18, 2008 |
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Last Updated Date | December 8, 2010 |
Start Date | June 2008 |
Estimated Primary Completion Date | August 2008 |
Current 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] |
Current 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] |
Descriptive Information[ + expand ][ + ]
Brief Title | A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator. |
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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. |
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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science |
Condition | Healthy Volunteer |
Intervention | 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 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 16 |
Estimated Completion Date | August 2008 |
Estimated Primary Completion Date | August 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 |
Gender | Male |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00720421 |
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Other Study ID Numbers | D1140C00003 |
Has Data Monitoring Committee | No |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Not Provided |
Investigators | Principal Investigator: J.M.A. Van Gerven, MD, PhD CHDR Leiden, the Netherlands |
Verification Date | November 2008 |
Locations[ + expand ][ + ]
Centre for Human Drug Research | Leiden, Netherlands |
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