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

Primary Purpose

Severe Hypertriglyceridemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epanova (4 g) and Lovaza (4 g)
Lovaza (4 g) and Epanova (4 g)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Hypertriglyceridemia focused on measuring Eicosapentaenoic Acid, Docosahexaenoic Acid, Hypertriglyceridemia, Omega-3 acid ethyl esters, Omega-3 carboxylic acids, Epanova, Lovaza, bioavailability, pharmacokinetics, low-fat meal, high-fat meal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Radiant Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Epanova-Lovaza-Epanova-Lovaza

Lovaza-Epanova-Lovaza-Epanova

Arm Description

Outcomes

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)
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2010
Last Updated
June 19, 2015
Sponsor
AstraZeneca
Collaborators
Radiant Research
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1. Study Identification

Unique Protocol Identification Number
NCT01208961
Brief Title
Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation
Acronym
ECLIPSE
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Radiant Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hypertriglyceridemia
Keywords
Eicosapentaenoic Acid, Docosahexaenoic Acid, Hypertriglyceridemia, Omega-3 acid ethyl esters, Omega-3 carboxylic acids, Epanova, Lovaza, bioavailability, pharmacokinetics, low-fat meal, high-fat meal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epanova-Lovaza-Epanova-Lovaza
Arm Type
Active Comparator
Arm Title
Lovaza-Epanova-Lovaza-Epanova
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Epanova (4 g) and Lovaza (4 g)
Other Intervention Name(s)
Note that omefas corresponds to omega-3 carboxylic acids
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lovaza (4 g) and Epanova (4 g)
Other Intervention Name(s)
Note that omefas corresponds to omega-3 carboxylic acids
Intervention Description
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
Primary Outcome Measure Information:
Title
AUC(0-t): Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (the Final Time With a Concentration ≥ LOQ)
Description
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.
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.
Title
AUC(Inf): Area Under the Plasma Concentration-time Curve From 0 to Infinity
Description
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.
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.
Title
C(Max): Maximum Plasma Concentration
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23312053
Citation
Davidson MH, Johnson J, Rooney MW, Kyle ML, Kling DF. A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova((R)) compared to Lovaza((R)) in a pharmacokinetic single-dose evaluation) study. J Clin Lipidol. 2012 Nov-Dec;6(6):573-84. doi: 10.1016/j.jacl.2012.01.002. Epub 2012 Jan 24.
Results Reference
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Epanova® Compared to Lovaza® In a Pharmacokinetic, Single-dose, Evaluation

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