A Drug-Drug Interaction Study to Study the Effect of AZD1981 on Warfarin

February 8, 2011 updated by: AstraZeneca

A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily) for Two Weeks and Single Doses of Warfarin (25 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Warfarin and the Effect of AZD1981 on Warfarin Pharmacodynamics in Healthy Male Volunteers

The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Have a body mass index between 19 and 30 kg/m2 and weight at least 65 kg and no more than 100 kg
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening
  • Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study

Exclusion Criteria:

  • Volunteer that is inferred to have an increased sensitivity to warfarin based on genotype of CYP2C9 and VKORC1.
  • Any clinically significant disease or disorder
  • Any clinically relevant abnormal findings in physical examination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
AZD1981, low dose, + Warfarin
Drug: AZD1981
100 mg per oral, twice daily for 14 days
Drug: Warfarin
10 x 2.5 mg per oral, once daily at day 1 and day 15
Other Names:
  • Waran
Drug: AZD1981
4 x 100 mg per oral, twice daily for 14 days
Experimental: Treatment B
AZD1981, high dose, + Warfarin
Drug: AZD1981
100 mg per oral, twice daily for 14 days
Drug: Warfarin
10 x 2.5 mg per oral, once daily at day 1 and day 15
Other Names:
  • Waran
Drug: AZD1981
4 x 100 mg per oral, twice daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)
Time Frame: PK sampling will be performed regularly from Day 1 to Day 22
PK sampling will be performed regularly from Day 1 to Day 22

Secondary Outcome Measures

Outcome Measure
Time Frame
Explore possible changes in the anticoagulative activity of Warfarin measured by INR .
Time Frame: Will be performed at screening and at all visits during the study period.
Will be performed at screening and at all visits during the study period.
Pharmacokinetics for AZD1981 measured by AUCτ, Css,max, tmax,ss and CLss/F
Time Frame: PK sampling will be performed regularly from Day 15 to Day 22.
PK sampling will be performed regularly from Day 15 to Day 22.
Safety and tolerability of AZD1981
Time Frame: Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study.
Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Christer Hultqvist, MD, AstraZeneca
  • Principal Investigator: Aslak Rautio, Quintiles AB
  • Principal Investigator: Wofgang Kühn, MD, Quintiles AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

February 9, 2011

Last Update Submitted That Met QC Criteria

February 8, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9830C00017
  • 2010-021956-24 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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