Pharmacokinetic Interaction Between AZD3480 and Donepezil

This study has been terminated.
(Ended prematurely - The trial never commenced.)
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: July 9, 2008
Last updated: August 12, 2014
Last verified: August 2014
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.

Condition Intervention Phase
Alzheimer's Disease
Drug: AZD3480
Drug: Donepezil
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling occasions during ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: December 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
AZD3480 + Donepezil
Drug: AZD3480
18 total doses of 40 mg, on days 1-18
Drug: Donepezil
One single dose of mg on day 5


Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00713765

United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
Study Director: Hans Göran Hårdemark AstraZeneca R&D, Sodertalje, Sweden
Principal Investigator: Simon Constable ICON Development Solutions, Manchester, UK
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00713765     History of Changes
Other Study ID Numbers: D3690C00005  EudraCt No.2008-002847-17 
Study First Received: July 9, 2008
Last Updated: August 12, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Healthy volunteers

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 03, 2016