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Completed

NCT Number: NCT01199341

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

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

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Key information

Conditions

Pharmakokinetic

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1981

Drug

100 mg per oral, twice daily for 14 days

Warfarin

Drug

10 x 2.5 mg per oral, once daily at day 1 and day 15

Other names: Waran

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 10, 2010
Registry last updated
Feb 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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