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

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

Official Title
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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

Conditions
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Pharmakokinetic

Intervention / Treatment
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* Drug: AZD1981
* Drug: Warfarin
* Drug: AZD1981


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>AZD1981, low dose, + Warfarin | Drug: AZD1981<br>* 100 mg per oral, twice daily for 14 days<br>Drug: Warfarin<br>* 10 x 2.5 mg per oral, once daily at day 1 and day 15<br>* Other names: Waran;|
| Experimental: Treatment B<br>AZD1981, high dose, + Warfarin | Drug: Warfarin<br>* 10 x 2.5 mg per oral, once daily at day 1 and day 15<br>* Other names: Waran;Drug: AZD1981<br>* 4 x 100 mg per oral, twice daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Drug-Drug interaction, warfarin, AZD1981