Drug Interaction Study Between AZD3480 and Warfarin

Alzheimer's Disease Clinical Trial

— DDI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689637
• Other study ID #: D3690C00014
• Secondary ID: EudraCt nr 2007-
• Status: Completed
• Phase: Phase 1
• First received: May 29, 2008
• Last updated: June 30, 2009
• Start date: September 2007
• Est. completion date: February 2009

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
Sweden	Research SIte	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Frequent sampling occasions during days 5 and 6	No
Secondary	Safety variables (adverse events, blood pressure, pulse, safety lab)		During the whole treatment period	Yes