Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation (ECLIPSE)

This study has been completed.
Sponsor:
Collaborator:
Radiant Research
Information provided by (Responsible Party):
Omthera Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01208961
First received: September 23, 2010
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.


Condition Intervention Phase
Severe Hypertriglyceridemia
Drug: Epanova (4 g) and Lovaza (4 g)
Drug: Lovaza (4 g) and Epanova (4 g)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Four-Way Crossover Study to Compare the Relative Bioavailability of a Single Dose of Epanova® With Lovaza® After a Low-Fat and High-Fat Meal

Resource links provided by NLM:


Further study details as provided by Omthera Pharmaceuticals, Inc:

Primary Outcome Measures:
  • AUC(0-t): Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (the Final Time With a Concentration ≥ LOQ) [ Time Frame: Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours. ] [ Designated as safety issue: No ]
    Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.

  • AUC(Inf): Area Under the Plasma Concentration-time Curve From 0 to Infinity [ Time Frame: Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours. ] [ Designated as safety issue: No ]
    Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.

  • C(Max): Maximum Plasma Concentration [ Time Frame: Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours. ] [ Designated as safety issue: No ]
    Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.


Enrollment: 54
Study Start Date: September 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epanova-Lovaza-Epanova-Lovaza Drug: Epanova (4 g) and Lovaza (4 g)
Single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals
Active Comparator: Lovaza-Epanova-Lovaza-Epanova Drug: Lovaza (4 g) and Epanova (4 g)
Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose ofEpanova (omefas),4x1g capsules, taken with high-fat meals

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women, aged ≥18.
  • Normal healthy volunteers based on medical history, clinical assessments, and laboratory assessments.
  • Body mass index 25-35 kg/m2.
  • Willingness to maintain current activity level.
  • Willingness to adhere to the Therapeutic Lifestyle Changes (TLC)diet during screening and treatment washout periods.

Exclusion Criteria:

  • Intolerance to omega-3 fatty acids, ethyl esters, or fish.
  • Unable or unwilling to eat the study meals.
  • Use of fish oil, other EPA or DHA containing supplements, or EPA and/or DHA fortified foods within 60 days of Visit 2, or during the study.
  • Consumption of any fish within 7 days of Visit 2, or during the study.
  • Use of flaxseed, perilla seed, hemp, spirulina, or black currant oils within 7 days of Visit 2, or during the study.
  • History of malabsorption syndrome, Crohn's disease, acute or chronic pancreatitis, pancreatic insufficiency, small bowel resection.
  • Women who are pregnant, lactating, or planning to become pregnant during the study period, or women of childbearing potential who are not using acceptable contraceptive methods. A woman is considered of childbearing potential if she is not surgically sterile or is less than 1 year since last menstrual period. Examples of acceptable contraceptive methods include abstinence, intrauterine device (IUD) or double barrier method, oral or injectable contraceptives.
  • Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
  • Exposure to any investigational product, within 28 days prior to Visit 1.
  • Any other condition the investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208961

Locations
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60654
Sponsors and Collaborators
Omthera Pharmaceuticals, Inc
Radiant Research
  More Information

Publications:
Responsible Party: Omthera Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01208961     History of Changes
Other Study ID Numbers: OM-EPA-001
Study First Received: September 23, 2010
Results First Received: July 16, 2013
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Omthera Pharmaceuticals, Inc:
Eicosapentaenoic Acid
Docosahexaenoic Acid
Hypertriglyceridemia
Omega-3 free fatty acids
Omega-3 ethyl ester acids
Epanova
Lovaza
bioavailability
pharmacokinetics
low-fat meal
high-fat meal

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014