Skip to content

Drug Interaction Study Between AZD3480 and Aripiprazole in Healthy Subjects

A Single-Centre, Double-Blind, Randomised, Parallel Group Study of Repeated Oral Doses of AZD3480/Placebo and a Single Dose of Aripiprazole to Evaluate the Pharmacokinetic Interaction Between AZD3480 and Aripiprazole in Healthy Subjects (Phase I)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00689559
Enrollment
52
Registered
2008-06-03
Start date
2008-03-31
Completion date
2009-04-30
Last updated
2009-07-02

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

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease, AZD3480, Aripiprazole

Brief 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.

Interventions

AZD3480 capsules qd, oral, 22 days

DRUGPlacebo

Placebo qd, 12 days

DRUGAripiprazole

single dose on day 5

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
PK variablesFrequent sampling occasions during

Secondary

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

Countries

Sweden

Outcome results

None listed

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