A Drug-Drug Interaction Study to Study the Effect of AZD1981 on Warfarin
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
2 other identifiers
interventional
28
1 country
1
Brief Summary
The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2010
CompletedFirst Posted
Study publicly available on registry
September 10, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 9, 2011
February 1, 2011
2 months
September 9, 2010
February 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)
PK sampling will be performed regularly from Day 1 to Day 22
Secondary Outcomes (3)
Explore possible changes in the anticoagulative activity of Warfarin measured by INR .
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
PK sampling will be performed regularly from Day 15 to Day 22.
Safety and tolerability of AZD1981
Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study.
Study Arms (2)
Treatment A
EXPERIMENTALAZD1981, low dose, + Warfarin
Treatment B
EXPERIMENTALAZD1981, high dose, + Warfarin
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Uppsala, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christer Hultqvist, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Aslak Rautio
Quintiles AB
- PRINCIPAL INVESTIGATOR
Wofgang Kühn, MD
Quintiles AB
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2010
First Posted
September 10, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 9, 2011
Record last verified: 2011-02