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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pharmakokinetic

Treatments: Drug: Warfarin; Drug: AZD1981

Study type: Interventional

Funder types: Industry

Identifiers

NCT01199341

2010-021956-24 (EudraCT Number)

D9830C00017

Details and patient eligibility

About

The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Treatment A

Experimental group

Description:

AZD1981, low dose, + Warfarin

Treatment:

Drug: AZD1981

Drug: AZD1981

Drug: Warfarin

Treatment B

Experimental group

Description:

AZD1981, high dose, + Warfarin

Treatment:

Drug: AZD1981

Drug: AZD1981

Drug: Warfarin