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Drug Interaction Study Between AZD3480 and Warfarin (DDI)

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

AZD3480

Placebo

Warfarin

About this trial

This is an interventional basic science trial for Alzheimer's Disease focused on measuring AZD3480, Warfarin, Drug interaction

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Research SIte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

AZD3480 + warfarin

Placebo+ warfarin

Outcomes

Primary Outcome Measures

PK variables

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00689637

First Posted

May 29, 2008

Last Updated

June 30, 2009

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00689637

Brief Title

Drug Interaction Study Between AZD3480 and Warfarin

Acronym

DDI

Official Title

A Single-Centre, Double Blind, Randomized, Two-Way Cross-Over Study of Repeated Doses of AZD3480 and Single Dose of Warfarin to Evaluate the Pharmacokinetic Interaction of AZD3480 and Warfarin and the Effect of AZD3480 Pharmacodynamic in Healthy Male Subjects (Phase I

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

AZD3480, Warfarin, Drug interaction

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AZD3480 + warfarin

Arm Title

Arm Type

Experimental

Arm Description

Placebo+ warfarin

Intervention Type

Drug

Intervention Name(s)

AZD3480

Intervention Description

AZD3480 capsules qd, 12 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo capsules qd, 12 days

Intervention Type

Drug

Intervention Name(s)

Warfarin

Intervention Description

Warfarin: single dose on day 6

Primary Outcome Measure Information:

Title

PK variables

Time Frame

Frequent sampling occasions during days 5 and 6

Secondary Outcome Measure Information:

Title

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

Time Frame

During the whole treatment period

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans-Göran Hårdemark, MD

Organizational Affiliation

Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Cyril Clarke, MD

Organizational Affiliation

ICON Development Solutions Manchester, UK

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research SIte

City

Uppsala

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Drug Interaction Study Between AZD3480 and Warfarin

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