CompletedPhase 1

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

Sweden28 participantsStarted 2010-10

Plain-language summary

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

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

Trial details

NCT IDNCT01199341

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-12

View on ClinicalTrials.gov More Pharmakokinetic trials