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A Drug-Drug Interaction Study to Assess the Effects of Multiple Doses of Mipomersen (200 mg SC) on Single-Dose Warfarin (25 mg) Pharmacodynamics and Pharmacokinetics in Healthy Adult Subjects
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.
Details
| Lead sponsor | Kastle Therapeutics, LLC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 18 |
| Start date | 2010-05 |
| Completion | 2010-07 |
Conditions
- Healthy
Interventions
- warfarin sodium
- mipomersen sodium; warfarin sodium
Primary outcomes
- Area under the effect curve (AUC), for INR (international normalized ratio), PT (prothrombin time), and aPTT (activated partial thromboplastin time) — Serial sampling up to 144 hours post dose
- Maximal Value (MAX) for INR, PT and aPTT — Serial sampling up to 144 hours post dose
- Time of maximal effect (Tmax) for INR, PT, and aPTT — Serial sampling up to 144 hours post dose
Countries
United States