Drug Interaction Study Between AZD3480 and Warfarin
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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
Outcome Measures for this Clinical Trial
Primary Measures
- PK variables
- Time Frame: Frequent sampling occasions during days 5 and 6
Safety Issue?: No
- Time Frame: Frequent sampling occasions during days 5 and 6
Secondary Measures
- Safety variables (adverse events, blood pressure, pulse, safety lab)
- Time Frame: During the whole treatment period
Safety Issue?: Yes
- Time Frame: During the whole treatment period
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Hans-Göran Hårdemark, MD Study Director Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00689637
