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Drug Interaction Study Between AZD3480 and Warfarin (DDI)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 29, 2008
Last updated: June 30, 2009
Last verified: June 2009
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 Intervention Phase
Alzheimer's Disease Drug: AZD3480 Drug: Placebo Drug: Warfarin Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment: 26
Study Start Date: September 2007
Study Completion Date: February 2009
Arms Assigned Interventions
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


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00689637

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

Responsible Party: Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AstraZeneca R&D Södertälje, Sweden Identifier: NCT00689637     History of Changes
Other Study ID Numbers: D3690C00014
EudraCt nr 2007-004756-37
Study First Received: May 29, 2008
Last Updated: June 30, 2009

Keywords provided by AstraZeneca:
Drug interaction

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Anticoagulants processed this record on September 19, 2017