Pharmakokinetic
Conditions
Keywords
Phase 1, Drug-Drug interaction, warfarin, AZD1981
Brief summary
The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.
Interventions
DRUGAZD1981
100 mg per oral, twice daily for 14 days
DRUGWarfarin
10 x 2.5 mg per oral, once daily at day 1 and day 15
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
Countries
Sweden
Outcome results
None listed