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TerminatedNCT00713765Updated Aug 15, 2014

Pharmacokinetic Interaction Between AZD3480 and Donepezil

A Phase 1 interventional study of AZD3480 and Donepezil in Alzheimer's Disease, sponsored by AstraZeneca. Terminated at 1 site in United Kingdom. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-15.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Why this study was terminated
Ended prematurely - The trial never commenced.
Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • Healthy volunteers
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 33 is below the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    A

    AZD3480 + Donepezil

    Drug: AZD3480 · Drug: Donepezil

Interventions

  • DrugAZD3480

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

  • DrugDonepezil

    One single dose of mg on day 5

06

What researchers measure

Primary outcomes

  1. PK variables

    Time frame: Frequent sampling occasions during

Secondary outcomes

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

    Time frame: During the whole treatment period

07

Study locations

1 site
  • Research Site
    Manchester, United Kingdom
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00713765
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jul 11, 2008
Start date
Dec 2008
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Aug 15, 2014

Study contacts

Hans Göran Hårdemark
study director · AstraZeneca R&D, Sodertalje, Sweden
Simon Constable
principal investigator · ICON Development Solutions, Manchester, UK

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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