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CompletedNCT00689559Updated Jul 2, 2009

Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

A Phase 1 interventional study of AZD3480 and Placebo in Alzheimer's Disease, sponsored by AstraZeneca. Completed at 1 site in Sweden. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-02.

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

Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • Alzheimer's disease
  • AZD3480
  • Aripiprazole
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 52 is below the median of 70 across 2,808 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
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Provision of signed written informed consent
  • Clinically normal physical findings and laboratory values

Exclusion criteria

Exclusion Criteria:

  • Clinically significant illness or clinically relevant trauma within three weeks before the first dose
  • History of clinically significant disease
  • Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    1

    AZD3480 + Aripiprazole

    Drug: AZD3480 · Drug: Aripiprazole

  • Experimental
    2

    Placebo + Aripiprazole

    Drug: Placebo · Drug: Aripiprazole

Interventions

  • DrugAZD3480

    AZD3480 capsules qd, oral, 22 days

  • DrugPlacebo

    Placebo qd, 12 days

  • DrugAripiprazole

    single dose on day 5

    Also known as: Abilify

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
    Uppsala, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00689559
Lead sponsor
AstraZeneca
First posted
Jun 3, 2008
Start date
Mar 2008
Completion
Apr 2009
Last update
Jul 2, 2009

Study contacts

Lennart Jeppsson
study director · AstraZeneca R&D, Södertälje, Sweden
Ctril Clarke, MD
principal investigator · ICON Development Solutions UK

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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