Pharmacokinetic Interaction Between AZD3480 and Donepezil

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.

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