TerminatedPhase 1

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

Lead sponsor

AstraZeneca

Asset

AZD3480

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 20-60

Primary endpoint

•PK variables

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDD3690C00005

SecondaryEudraCt No.2008-002847-17

NCT IDNCT00713765

Timeline

Milestones

Study first posted2008-07-11estimated

Study start2008-12 (month precision)

Primary completion2008-12actual (month precision)

Study completion2008-12actual (month precision)

Last update posted2014-08-15estimated

Assets

Drug assets

AZD3480

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years

Maximum age60 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety variables (adverse events, blood pressure, pulse, safety lab)

Time frame:During the whole treatment period

event count, event

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

PK variables

Time frame:Frequent sampling occasions during

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.