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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01199341
First received: September 9, 2010
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Pharmakokinetic
Drug: AZD1981
Drug: Warfarin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Waran
Experimental: Treatment B
AZD1981, high dose, + Warfarin
Drug: Warfarin
10 x 2.5 mg per oral, once daily at day 1 and day 15
Other Name: Waran
Drug: AZD1981
4 x 100 mg per oral, twice daily for 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199341

Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Christer Hultqvist, MD AstraZeneca
Principal Investigator: Aslak Rautio Quintiles AB
Principal Investigator: Wofgang Kühn, MD Quintiles AB
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01199341     History of Changes
Other Study ID Numbers: D9830C00017, 2010-021956-24
Study First Received: September 9, 2010
Last Updated: February 8, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Phase 1
Drug-Drug interaction
warfarin
AZD1981

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014