Status:
WITHDRAWN
A Drug-Drug Interaction Study Between AZD9668 and Warfarin to Study the Effect of AZD9668 on the Metabolism and Effect of Warfarin
Lead Sponsor:
AstraZeneca
Conditions:
Pharmacokinetics
Pharmacodynamics
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to determine whether the treatment with AZD9668 will affect the metabolism and effect of Warfarin.
Eligibility Criteria
Inclusion
- Provision of signed informed consent (including genotyping screening sample for CYP2C9 and VKORC1) prior to any study specific procedures
- Subjects must be willing to use a barrier method of contraception, unless their partners are post-menopausal or surgically sterile, or if a female partner is of childbearing potential the subject must use a barrier method of contraception (condom) and the partner must use accepted contraceptive methods (oral contraceptive, implant, long term injectable contraceptive or intrauterine device), from first dose of IP (warfarin and AZD9668) until 3 months after last dose of IP (warfarin and AZD9668)
- Have a body mass index between 19 and 30 kg/m2 (inclusive) and a weight between 50 and 100 kg (inclusive)
- Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1.
Exclusion
- Any clinically significant disease or disorder
- Subject predicted to have high sensitivity to warfarin based on CYP2C9 and VKORC1 genotypes
- Any clinically relevant abnormal findings in physical examination
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01214122
Start Date
November 1 2010
End Date
December 1 2010
Last Update
January 29 2013
Active Locations (2)
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1
Research Site
Linköping, Sweden
2
Research Site
Uppsala, Sweden