A Sedation/Cognition/Electroencephalogram (EEG) Study using AZD7325 and Comparator.
Study identifier:D1140C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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.
Medical condition
Healthy Volunteer
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD7325, AZD7325, AZD7325, AZD7325, AZD7325, AZD7325, AZD7325, AZD7325, AZD7325, AZD7325, AZD7325, AZD7325, Lorazepam, Lorazepam, Lorazepam, Lorazepam, Lorazepam, Lorazepam, Lorazepam, Lorazepam
Sex
Male
Actual enrollment
16
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Jun 2008
Primary Completion Date: 01 Aug 2008
Study Completion Date: 01 Aug 2008
Study design
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
| 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 | 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 |
Contacts
Investigators
Principal Investigator
J.M.A. Van Gerven
CHDR Leiden, the Netherlands
