Phase 1 Completed N=15 Randomized Treatment

An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis

Source: ClinicalTrials.gov NCT02189252 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcomePrimary: Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA — 17000; 18000; 12500 hr*nmol/mL — p=0.2702

Summary

This is a randomized, open-label crossover study. The primary objective of this study is to compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA	17000; 18000; 12500	0.2702
PRIMARY Baseline-adjusted Cmax for Plasma Total EPA + Total DHA	1090; 1200; 712	0.0511
SECONDARY Baseline-adjusted AUC0-24 for Plasma Total EPA	3510; 3930; 1730	0.0210 sig
SECONDARY Baseline-adjusted Cmax for Plasma Total EPA	221; 255; 100	0.0025 sig
SECONDARY Baseline-adjusted AUC0-24 for Plasma Total DHA	1710; 1550; 2190	0.6833
SECONDARY Baseline-adjusted Cmax for Plasma Total DHA	116; 118; 128	0.9034
SECONDARY Baseline-adjusted AUC0-24 for Plasma Total DPA	244; 380; 108	0.0391 sig
SECONDARY Baseline-adjusted Cmax for Plasma Total DPA	23.0; 26.4; 11.1	0.0186 sig

Eligibility Criteria

Inclusion Criteria

Male or female, ≥18 years of age;
History of serum TG concentration ≥500 mg/dL within the past 5 years;
Have at least one episode of documented hospitalization for pancreatitis due to hypertriglyceridemia in his/her lifetime;
Have no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of physical examination, ECG, medical history, and routine laboratory test results;
Willing to maintain his/her current activity level and to follow either the NCEP TLC diet with a caloric target for weight maintenance or a prescribed low-fat diet during the screening, treatment, and washout periods (Visits 1 through 6b; Weeks -4 through 12);
Willing to eat the standardized breakfast, lunch, and dinner meals and snacks before and during Visits 4b and 6b (Weeks 4 and 12);
Willing to abstain from alcohol consumption and avoid vigorous physical activity for 48 hours prior to Visits 3 through 6b (Weeks 0 through 12); and
Subject understands the study procedures and is willing and able to sign the informed consent form to participate in the study and the Health Insurance Portability and Accountability Act authorization for release of relevant protected health information to the Investigators and study personnel.

Exclusion Criteria

An allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, fish, or any of the components of the standardized breakfast, lunch, or dinner meals or snacks (as described to them by study staff)
Poorly controlled hypertension (resting blood pressure ≥160 mmHg systolic and/or ≥100 mmHg diastolic) prior to randomization (Visit 3 [Week 0])
A history of cancer (other than basal cell carcinoma) in the last 2 years
A recent cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment), aortic aneurysm or resection, carotid endarterectomy, or revascularization procedure within the 6 months prior to Visit 1

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Data sourced from ClinicalTrials.gov (NCT02189252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.