Drug Interaction Study Between AZD3480 and Warfarin (DDI)

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00689637

First received: May 29, 2008

Last updated: June 30, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 29, 2008

Last Updated Date

June 30, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

PK variables [ Time Frame: Frequent sampling occasions during days 5 and 6 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00689637 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Drug Interaction Study Between AZD3480 and Warfarin

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: AZD3480
AZD3480 capsules qd, 12 days
Drug: Placebo
Placebo capsules qd, 12 days
Drug: Warfarin
Warfarin: single dose on day 6

Study Arm (s)

Experimental: 1
AZD3480 + warfarin
Interventions:
- Drug: AZD3480
- Drug: Warfarin
Experimental: 2
Placebo+ warfarin
Interventions:
- Drug: Placebo
- Drug: Warfarin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT00689637

Other Study ID Numbers ^ICMJE

D3690C00014, EudraCt nr 2007-004756-37

Has Data Monitoring Committee

Responsible Party

Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AstraZeneca R&D Södertälje, Sweden

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Hans-Göran Hårdemark, MD	Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
Principal Investigator:	Cyril Clarke, MD	ICON Development Solutions Manchester, UK

Information Provided By

AstraZeneca

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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