Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®) - ECLIPSEIII
Study identifier:OM-EPA-009
ClinicalTrials.gov identifier:NCT02859129
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-Label, 2-Cohort Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®), to Assess the Dose Proportionality of Epanova™, and to Compare the Systemic Exposure of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Following Multiple Doses of Epanova™ and Vascepa® in Healthy Normal Subjects
Medical condition
Hypertriglyceridemia
Phase
Phase 1
Healthy volunteers
Yes
Study drug
rosuvastatin 40 mg tablet, Epanova™ QD (2 x 1 g capsules), Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose, Multiple (20) oral doses of 2 g Vascepa® every 12 hours
Sex
All
Actual Enrollment
114
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Sept 2013
Primary Completion Date: 01 Nov 2013
Study Completion Date: 01 Nov 2013
Study design
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Rosuvastatin Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1). | Drug: rosuvastatin 40 mg tablet Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1). Other Name: Crestor |
| Experimental: Epanova® Multiple oral doses of 2 g (2 x 1 g capsules) Epanova® QD for 10 consecutive days (Days 4 to 13) | Drug: Epanova™ QD (2 x 1 g capsules) Multiple oral doses of 2 g (2 x 1 g capsules) Epanova™ QD for 10 consecutive days (Days 4 to 13) Other Name: omega-3 carboxylic acids |
| Experimental: Epanova® + Crestor® Epanova® multiple oral doses of 4 g (4 x 1 g capsules) QD for 13 consecutive days (Days 14 to 26) with coadministration of single 40 mg (1 x 40 mg tablet) oral dose of rosuvastatin (Crestor®) with the 11th dose of 4 g Epanova® on Day 24 | Drug: Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose Multiple oral doses of 4 g Epanova™ QD for 13 consecutive days with coadministration of single 40 mg oral dose of rosuvastatin (Crestor®) with the 11th dose of Epanova™ on Day 24 Other Name: omega-3 carboxylic acids Other Name: Crestor |
| Active Comparator: Vascepa® Vascepa® multiple oral doses of 2 g (2 x 1 g capsules) every 12 hours for 20 consecutive days (Days 1 to 20). | Drug: Multiple (20) oral doses of 2 g Vascepa® every 12 hours Multiple oral doses of 2 g (2 x 1 g capsules) Vascepa® every 12 hours for 20 consecutive days (Days 1 to 20). Other Name: icosapent ethyl |
Contacts
Investigators
Principal Investigator
Michael D Davidson
Omthera Pharmaceuticals/AstraZeneca
