A healthy volunteer study to evaluate reversibility of induced impairment of cognition
Study identifier:D2285M00021
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A single-centre, randomised, double-blind, placebo-controlled, four-period cross-over study to evaluate the scopolamine cognition model in healthy male subjects using AZD1446 and donepezil versus placebo
Medical condition
Cognition
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD1446, donepezil, Placebo
Sex
Male
Actual Enrollment
20
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Dec 2009
Primary Completion Date: 01 Apr 2010
Study Completion Date: 01 Apr 2010
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: A Single dose of AZD1446 10 mg | Drug: AZD1446 capsule; single oral dose |
| Experimental: B Single dose of AZD1446 80 mg | Drug: AZD1446 capsule, single oral dose |
| Active Comparator: C Single Dose of Donepezil 5 mg | Drug: donepezil capsule, single oral dose Other Name: Aricept |
| Placebo Comparator: D Single dose of placebo to match AZD1446 | Drug: Placebo capsule, single oral dose |
