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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Pharmacokinetics Pharmacodynamics

Study Design

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Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A

AZD9668 - 2 x30mg tablets

Group Type EXPERIMENTAL

AZD9668

Intervention Type DRUG

60 mg orally twice daily for 11 days

Treatment B

Warfarin - 10 x2.5 mg tablets

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

10 x 2.5 (25) mg orally once daily on day 1 and on day 14

Interventions

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AZD9668

60 mg orally twice daily for 11 days

Intervention Type DRUG

Warfarin

10 x 2.5 (25) mg orally once daily on day 1 and on day 14

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes