Official Title: “A Double-Blind, Randomised, Cross-Over, Placebo-Controlled Study of Repeated Oral Doses of AZD3480 and a Single Dose of Donepezil to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Donepezil in Healthy Extensive and Poor Metabolisers of CYP2D6”

The aims of this study are to 1) examine the effects of AZD3480 and donepezil on the blood concentrations of each other and 2) assess the safety and tolerability of the combined administration of AZD3480 with donepezil.

Study Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: AZD3480
  • 18 total doses of 40 mg, on days 1-18
• Drug: Donepezil
  • One single dose of mg on day 5

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • AZD3480 + Donepezil

Primary Measures

• PK variables
  • Time Frame: Frequent sampling occasions during
    Safety Issue?: No

Secondary Measures

• Safety variables (adverse events, blood pressure, pulse, safety lab)
  • Time Frame: During the whole treatment period
    Safety Issue?: Yes

Inclusion Criteria:

• Provision of informed consent prior to any study-specific procedures
• BMI between 18 and 30 kg/m2
• Medical and surgical history and physical examination without any clinically significant findings
• Genotyped as an EM, defined in this study as having ≥ 1.5 functional CYP2D6 alleles, or a PM, defined as having zero functional CYP2D6 alleles

Exclusion Criteria:

• History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
• Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product
• Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Hans Göran Hårdemark Study Director AstraZeneca R&D, Sodertalje, Sweden  

Overall Contact: ICON Development Solutions 0161 232 2802 jean-maryj@iconus.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00713765

Study ID Number: D3690C00005

ClinicalTrials.gov Identifier: NCT00713765

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency