A Sedation/Cognition/EEG Study Using AZD6280 and Comparator
Overview[ - collapse ][ - ]
| Purpose | The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on sleepiness, concentration and brain activity. |
|---|---|
| Condition | Healthy Volunteer |
| Intervention | Drug: AZD6280 Drug: AZD6280 Drug: Lorazepam Drug: Placebo |
| Phase | Phase 1 |
| Sponsor | AstraZeneca |
| Responsible Party | AstraZeneca |
| ClinicalTrials.gov Identifier | NCT00750802 |
| First Received | September 10, 2008 |
| Last Updated | June 25, 2009 |
| Last verified | June 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 10, 2008 |
|---|---|
| Last Updated Date | June 25, 2009 |
| Start Date | September 2008 |
| Estimated Primary Completion Date | December 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/EEG Study Using AZD6280 and Comparator |
|---|---|
| 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 |
| Brief Summary | The purpose of the study is to determine the effects of AZD6280 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: AZD6280 10mg Capsule, oral, single-dose Drug: AZD6280 40mg Capsule, oral, single-dose Drug: Lorazepam 2mg tablet, oral single-dose Other Names: AtivanDrug: Placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 17 |
| Estimated Completion Date | December 2008 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility 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 |
| Gender | Male |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00750802 |
|---|---|
| Other Study ID Numbers | D0850C00014 |
| Has Data Monitoring Committee | No |
| Information Provided By | AstraZeneca |
| Study Sponsor | AstraZeneca |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | June 2009 |
Locations[ + expand ][ + ]
| Research Site | Leiden, Netherlands |
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