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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
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 29, 2008
Last Updated: June 30, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
AZD3480
Warfarin
Drug interaction

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Warfarin
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014