Pharmacokinetic Interaction Between AZD3480 and Donepezil

AstraZeneca

Status and phase

Terminated

Phase 1

Conditions

Alzheimer's Disease

Treatments

Drug: Donepezil

Drug: AZD3480

Study type

Interventional

Funder types

Industry

Identifiers

NCT00713765

D3690C00005

EudraCt No.2008-002847-17

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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