Drug Interaction Study Between AZD3480 and Warfarin

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: AZD3480; Drug: Placebo; Drug: Warfarin

• Registration Number: NCT00689637
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Study Completion: 2009-02
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-30
• Last Update Posted: 2009-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD3480	AZD3480 + warfarin
1	Warfarin	AZD3480 + warfarin
2	Placebo	Placebo+ warfarin
2	Warfarin	Placebo+ warfarin

Primary Outcome Measures

Name	Time	Method
PK variables	Frequent sampling occasions during days 5 and 6

Secondary Outcome Measures

Name	Time	Method
Safety variables (adverse events, blood pressure, pulse, safety lab)	During the whole treatment period

Trial Locations

Locations (1)

Research SIte; 🇸🇪 Uppsala, Sweden