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

Study Overview
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Brief Summary
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The purpose of the study is to determine the effects of the compound AZD7325 as compared to lorazepam on sleepiness, concentration and brain activity.

Official Title
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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.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: AZD7325
* Drug: AZD7325
* Drug: AZD7325
* Drug: Lorazepam
* Drug: Lorazepam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>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 | Drug: AZD7325<br>* AZD7325 10 mg oral 2 capsules<br>Drug: AZD7325<br>* AZD7325 1 mg oral 2 capsules<br>Drug: AZD7325<br>* AZD7325 Placebo oral 2 capsules<br>Drug: Lorazepam<br>* Lorazepam 1 mg oral 2 tablets<br>Drug: Lorazepam<br>* Lorazepam Placebo oral 2 tablets<br>|
| Other: 2<br>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 | Drug: AZD7325<br>* AZD7325 10 mg oral 2 capsules<br>Drug: AZD7325<br>* AZD7325 1 mg oral 2 capsules<br>Drug: AZD7325<br>* AZD7325 Placebo oral 2 capsules<br>Drug: Lorazepam<br>* Lorazepam 1 mg oral 2 tablets<br>Drug: Lorazepam<br>* Lorazepam Placebo oral 2 tablets<br>|
| Other: 3<br>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 | Drug: AZD7325<br>* AZD7325 10 mg oral 2 capsules<br>Drug: AZD7325<br>* AZD7325 1 mg oral 2 capsules<br>Drug: AZD7325<br>* AZD7325 Placebo oral 2 capsules<br>Drug: Lorazepam<br>* Lorazepam 1 mg oral 2 tablets<br>Drug: Lorazepam<br>* Lorazepam Placebo oral 2 tablets<br>|
| Other: 4<br>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 | Drug: AZD7325<br>* AZD7325 10 mg oral 2 capsules<br>Drug: AZD7325<br>* AZD7325 1 mg oral 2 capsules<br>Drug: AZD7325<br>* AZD7325 Placebo oral 2 capsules<br>Drug: Lorazepam<br>* Lorazepam 1 mg oral 2 tablets<br>Drug: Lorazepam<br>* Lorazepam Placebo oral 2 tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests. |  | Test batteries will be performed at specified times both before and following study drug administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation and characterization of the pharmacokinetics of AZD6280. |  | Blood samples will be taken during the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, pharmacodynamic study