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

Phase 1

Completed

• Conditions: Pharmakokinetic
• Interventions: Drug: AZD1981; Drug: Warfarin

• Registration Number: NCT01199341
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Study Start: 2010-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-08
• Last Update Posted: 2011-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment B	AZD1981	AZD1981, high dose, + Warfarin
Treatment A	AZD1981	AZD1981, low dose, + Warfarin
Treatment A	Warfarin	AZD1981, low dose, + Warfarin
Treatment B	Warfarin	AZD1981, high dose, + Warfarin

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)	PK sampling will be performed regularly from Day 1 to Day 22

Secondary Outcome Measures

Name	Time	Method
Explore possible changes in the anticoagulative activity of Warfarin measured by INR .	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	PK sampling will be performed regularly from Day 15 to Day 22.
Safety and tolerability of AZD1981	Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden