Drug Interaction Study Between AZD3480 and Warfarin

NCT ID: NCT00689637

Last Updated: 2009-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

AZD3480 + warfarin

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

AZD3480 capsules qd, 12 days

Warfarin

Intervention Type DRUG

Warfarin: single dose on day 6

2

Placebo+ warfarin

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo capsules qd, 12 days

Warfarin

Intervention Type DRUG

Warfarin: single dose on day 6

Interventions

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AZD3480

AZD3480 capsules qd, 12 days

Intervention Type DRUG

Placebo

Placebo capsules qd, 12 days

Intervention Type DRUG

Warfarin

Warfarin: single dose on day 6

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Södertälje, Sweden

Principal Investigators

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Hans-Göran Hårdemark, MD

Role: STUDY_DIRECTOR

Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden

Cyril Clarke, MD

Role: PRINCIPAL_INVESTIGATOR

ICON Development Solutions Manchester, UK

Locations

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Research SIte

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCt nr 2007-004756-37

Identifier Type: -

Identifier Source: secondary_id

D3690C00014

Identifier Type: -

Identifier Source: org_study_id

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