A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily) for Two Weeks and Single Doses of Warfarin (25 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Warfarin and the Effect of AZD1981 on Warfarin Pharmacodynamics in Healthy Male Volunteers

AstraZeneca1 site in 1 country28 target enrollmentOctober 2010

ConditionsPharmakokinetic

InterventionsAZD1981 Warfarin

DrugsAZD1981 Warfarin

Overview

Phase: Phase 1
Intervention: AZD1981
Conditions: Pharmakokinetic
Sponsor: AstraZeneca
Enrollment: 28
Locations: 1
Primary Endpoint: Pharmacokinetics for (R)- and (S)-Warfarin, respectively measured by Cmax and Area Under the Curve (AUC)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

December 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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 VKORC
•Any clinically significant disease or disorder
•Any clinically relevant abnormal findings in physical examination

Arms & Interventions

Treatment A

AZD1981, low dose, + Warfarin

Intervention: AZD1981

Treatment A

AZD1981, low dose, + Warfarin

Intervention: Warfarin

Treatment B

AZD1981, high dose, + Warfarin

Intervention: Warfarin

Treatment B

AZD1981, high dose, + Warfarin

Intervention: AZD1981

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 .(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.)