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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00713765

Enrollment

Registered

2008-07-11

Start date

2008-12-31

Completion date

2008-12-31

Last updated

2014-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Healthy volunteers

Brief summary

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.

Interventions

DRUGAZD3480

18 total doses of 40 mg, on days 1-18

DRUGDonepezil

One single dose of mg on day 5

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
PK variables	Frequent sampling occasions during

Secondary

Measure	Time frame
Safety variables (adverse events, blood pressure, pulse, safety lab)	During the whole treatment period

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026