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”

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.

Study Type: Interventional

Study Design: Basic Science, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • AZD3480 + warfarin
• Experimental: 2
  • Placebo+ warfarin

Primary Measures

• PK variables
  • Time Frame: Frequent sampling occasions during days 5 and 6
    Safety Issue?: No

Secondary Measures

• Safety variables (adverse events, blood pressure, pulse, safety lab)
  • Time Frame: During the whole treatment period
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Hans-Göran Hårdemark, MD Study Director Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00689637

Study ID Number: D3690C00014

ClinicalTrials.gov Identifier: NCT00689637

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency