Pharmakokinetic Clinical Trial
Official title:
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
| Verified date | February 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
The primary purpose of this study is to determine whether the treatment with AZD1981 affect the exposure of Warfarin.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Research Site | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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. | No | |
| Secondary | Pharmacokinetics for AZD1981 measured by AUCt, Css,max, tmax,ss and CLss/F | PK sampling will be performed regularly from Day 15 to Day 22. | No | |
| Secondary | Safety and tolerability of AZD1981 | Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study. | Yes |