drugset / Trial / NCT01133366
A Study to Determine the Effects of Multiple Doses of Mipomersen (200 mg SC) on the Pharmacodynamics and Pharmacokinetics of Single-dose Warfarin
Non-randomizedCrossoverOpen-labelTreatment
Summary
The purpose of this study is to assess how blood clotting and thinning time is effected when a single dose of warfarin is given alone and when a single dose of warfarin is given with mipomersen; to assess the blood levels of a single dose of warfarin, a single dose of mipomersen, and a single dose of warfarin when given with mipomersen; and to assess the safety of mipomersen when given with or without warfarin.
Timeline
- Start
- 2010-05
- Primary completion
- 2010-05
- Completion
- 2010-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Warfarin | Small molecule | 25 mg | Oral |
| Subject | mipomersen | Antisense oligonucleotide | 200 mg | Subcutaneous |
Indications
No indication recorded.