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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

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 AZD1981 affect the exposure of Warfarin.

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Detailed Description

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Conditions

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Pharmakokinetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treatment A

AZD1981, low dose, + Warfarin

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

100 mg per oral, twice daily for 14 days

Warfarin

Intervention Type DRUG

10 x 2.5 mg per oral, once daily at day 1 and day 15

Treatment B

AZD1981, high dose, + Warfarin

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

10 x 2.5 mg per oral, once daily at day 1 and day 15

AZD1981

Intervention Type DRUG

4 x 100 mg per oral, twice daily for 14 days

Interventions

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AZD1981

100 mg per oral, twice daily for 14 days

Intervention Type DRUG

Warfarin

10 x 2.5 mg per oral, once daily at day 1 and day 15

Intervention Type DRUG

AZD1981

4 x 100 mg per oral, twice daily for 14 days

Intervention Type DRUG

Other Intervention Names

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Waran

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes