Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals
The primary objective of this study is to determine the effect of Epanova® on the pharmacokinetic and anticoagulant activity of warfarin.
The secondary objective of this study is to compare the systemic exposure of EPA and DHA following multiple-dose administration of Epanova®, a free fatty acid mixture, to Lovaza®, a mixture of fatty acid ethyl esters, under low-fat meal conditions since these products are likely to be administered to patients with cardiovascular disease who are recommended to consume low-fat meals.
|Hypertriglyceridemia||Drug: warfarin Drug: omefas Drug: omega-3-acid ethyl esters||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-label, 2-cohort Study to Evaluate the Effect of Multiple Doses of Epanova® on the Single Dose Pharmacokinetics and Pharmacodynamics of Warfarin and to Compare the Systemic Exposure of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Following Multiple-dose Administrations of Epanova® Compared to Lovaza® in Healthy Normal Subjects|
- Pharmacokinetics of R- and S- warfarin [ Time Frame: 168 hours ]The primary endpoints of this study will be the area under the curve (AUC)0-t, AUC0-inf, and maximum concentration (Cmax) of R- and S warfarin and the maximum International Normalized Ratio (INRmax) over 168 hours postdose and INR AUC0-168 when warfarin is administered with and without Epanova®.
- Pharmacodynamics of R- and S- warfarin [ Time Frame: 168 hours ]The INRmax over 168 hours postdose and INR AUC0-168 when warfarin is administered with and without Epanova®.
- Total EPA+DHA [ Time Frame: 24 hours ]The AUC0-tau and Cmax of baseline-adjusted total EPA+DHA following multiple doses (14 days) of Epanova® and Lovaza®.
|Study Start Date:||August 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Experimental: Warfarin and Epanova||
A single 25 mg dose of warfarin
Other Name: coumarin-based anticoagulantDrug: omefas
4 x 1 g capsule dose of Epanova®
Other Name: Epanova
|Active Comparator: Lovaza||
Drug: omega-3-acid ethyl esters
4 x 1 g capsule dose of Lovaza®
Other Name: Lovaza
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431690
|United States, Arizona|
|Tempe, Arizona, United States, 85283|
|Study Director:||Michael H Davidson, MD, FACC||Omthera Pharmaceuticals, Inc|