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Drug Interaction Study Between AZD3480 and Warfarin (DDI)

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ClinicalTrials.gov Identifier: NCT00689637
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : July 2, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: AZD3480 Drug: Placebo Drug: Warfarin Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : September 2007
Actual Study Completion Date : February 2009


Arm Intervention/treatment
Experimental: 1
AZD3480 + warfarin
Drug: AZD3480
AZD3480 capsules qd, 12 days
Drug: Warfarin
Warfarin: single dose on day 6
Experimental: 2
Placebo+ warfarin
Drug: Placebo
Placebo capsules qd, 12 days
Drug: Warfarin
Warfarin: single dose on day 6



Primary Outcome Measures :
  1. PK variables [ Time Frame: Frequent sampling occasions during days 5 and 6 ]

Secondary Outcome Measures :
  1. Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689637


Locations
Sweden
Research SIte
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans-Göran Hårdemark, MD Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
Principal Investigator: Cyril Clarke, MD ICON Development Solutions Manchester, UK

Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AstraZeneca R&D Södertälje, Sweden
ClinicalTrials.gov Identifier: NCT00689637     History of Changes
Other Study ID Numbers: D3690C00014
EudraCt nr 2007-004756-37
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
AZD3480
Warfarin
Drug interaction

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Warfarin
Anticoagulants