A Drug-Drug Interaction Study Between AZD9668 and Warfarin to Study the Effect of AZD9668 on the Metabolism and Effect of Warfarin

AstraZeneca

Status and phase

Withdrawn

Phase 1

Conditions

Pharmacodynamics

Pharmacokinetics

Treatments

Drug: AZD9668

Drug: Warfarin

Study type

Interventional

Funder types

Industry

Identifiers

D0520C00013

2010-022360-12 (EudraCT Number)

Details and patient eligibility

About

The primary purpose of this study is to determine whether the treatment with AZD9668 will affect the metabolism and effect of Warfarin.

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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