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

May 29, 2008
June 30, 2009
September 2007
Not Provided
PK variables [ Time Frame: Frequent sampling occasions during days 5 and 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00689637 on ClinicalTrials.gov Archive Site
Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Drug Interaction Study Between AZD3480 and Warfarin
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Alzheimer's Disease
  • Drug: AZD3480
    AZD3480 capsules qd, 12 days
  • Drug: Placebo
    Placebo capsules qd, 12 days
  • Drug: Warfarin
    Warfarin: single dose on day 6
  • Experimental: 1
    AZD3480 + warfarin
    Interventions:
    • Drug: AZD3480
    • Drug: Warfarin
  • Experimental: 2
    Placebo+ warfarin
    Interventions:
    • Drug: Placebo
    • Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
February 2009
Not Provided

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00689637
D3690C00014, EudraCt nr 2007-004756-37
No
Hans-Göran Hårdemark, MD, PhD, Medical Science Director, AstraZeneca R&D Södertälje, Sweden
AstraZeneca
Not Provided
Study Director: Hans-Göran Hårdemark, MD Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
Principal Investigator: Cyril Clarke, MD ICON Development Solutions Manchester, UK
AstraZeneca
June 2009

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