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

Phase 1CompletedNCT01199341

AstraZeneca28 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Pharmakokinetic

Interventions

AZD1981DRUG

100 mg per oral, twice daily for 14 days

WarfarinDRUG

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

AZD1981DRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Uppsala, Sweden

Outcomes

Primary Outcomes

Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)

Time frame: PK sampling will be performed regularly from Day 1 to Day 22

Secondary Outcomes

Explore possible changes in the anticoagulative activity of Warfarin measured by INR .

Time frame: Will be performed at screening and at all visits during the study period.

Pharmacokinetics for AZD1981 measured by AUCτ, Css,max, tmax,ss and CLss/F

Time frame: PK sampling will be performed regularly from Day 15 to Day 22.

Safety and tolerability of AZD1981

Time frame: Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study.

Data from ClinicalTrials.gov

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