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OpenTrials
Completed

NCT Number: NCT02859129

Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)

This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Neptune City, New Jersey, 07753, United States

About this study

The PK of rosuvastatin will be monitored following single-dose administration of rosuvastatin with and without multiple-dose administration of 4 g Epanova™ for 13 consecutive days in order to detect a possible interaction between rosuvastatin and Epanova™. The PK of total EPA, total DHA and total EPA+DHA will also be monitored following multiple-dose administration of Epanova™ with and without single-dose administration of 40 mg rosuvastatin. A single dose administration for rosuvastatin has been judged sufficient to yield plasma concentrations that will be detectable with an adequate validated analytical method and characterize adequately the PK of rosuvastatin.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female (non-childbearing potential)
  • Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening
  • Non-smoker
  • Medically healthy with no clinically significant laboratory profiles, vital signs or ECGs

Exclusion criteria

  • mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study
  • History or presence of myopathy and/or hypothyroidism.
  • History or presence of transaminase elevations
  • History or presence of hypersensitivity or idiosyncratic reaction to rosuvastatin, to other HMG-CoA reductase inhibitors, to Epanova™, to Vascepa®, or to related compounds
  • Known sensitivity or allergy to soybeans, fish, and/or shellfish.
  • Has consumed fish within 7 days prior to check-in.
  • Female subjects who are pregnant or lactating.
  • Positive urine drug and alcohol results at screening or check-in.
  • Positive urine cotinine at screening and check-in
  • Use of any drugs known to be inducers of CYP enzymes and/or P-gp
  • Donation of blood or significant blood loss within 56 days prior to the first dose of study medication.
  • Plasma donation within 7 days prior to the first dose of study medication.
  • Participation in another clinical trial within 28 days prior to the first dose of study medication.

Treatment and study plan

rosuvastatin 40 mg tablet

Drug

Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1).

Other names: Crestor

Epanova™ QD (2 x 1 g capsules)

Drug

Multiple oral doses of 2 g (2 x 1 g capsules) Epanova™ QD for 10 consecutive days (Days 4 to 13)

Other names: omega-3 carboxylic acids

Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose

Drug

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 names: omega-3 carboxylic acids, Crestor

Multiple (20) oral doses of 2 g Vascepa® every 12 hours

Drug

Multiple oral doses of 2 g (2 x 1 g capsules) Vascepa® every 12 hours for 20 consecutive days (Days 1 to 20).

Other names: icosapent ethyl

Primary outcomes

  1. ln-transformed Cmax,ss of baseline-adjusted total EPA, total DHA, and total EPA+DHA

    Time frame: Days 1 and 24

    ln-transformed Cmax,ss of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.

  2. ln-transformed AUC0-tau of baseline-adjusted total EPA, total DHA, and total EPA+DHA

    Time frame: Days 1 and 24

    ln-transformed AUC0-tau of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.

Secondary outcomes

  1. ln-transformed Cmax,ss of unadjusted total EPA, total DHA, and total EPA+DHA

    Time frame: Days 1 and 24

    ln-transformed Cmax,ss of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.

  2. dose proportionality of baseline-adjusted total EPA, total DHA, and total EPA+DHA systemic exposure will be assessed following multiple doses of Epanova™ 2 g and 4 g

    Time frame: Days 1 and 24

    In Cohort 1 only, dose proportionality of baseline-adjusted total EPA, total DHA, and total EPA+DHA systemic exposure will be assessed following multiple doses of Epanova™ 2 g and 4 g using an analysis of variance (ANOVA) on dose normalized data.

  3. ln-transformed AUC0-tau of unadjusted total EPA, total DHA, and total EPA+DHA

    Time frame: Days 1 and 24

    ln-transformed AUC0-tau of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA using a linear mixed effect model.

Other outcomes

  1. ln-transformed AUC0-24 exposure of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA following multiple doses of Epanova™ compared to multiple doses of Vascepa®

    Time frame: Days 1 and 24

    The systemic exposure of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA following multiple doses of Epanova™ compared to multiple doses of Vascepa® will be assessed by analyzing the ln-transformed AUC0-24. In addition to an ANOVA, an analysis of covariance (ANCOVA) including the baseline value as a covariate will be performed.

  2. AEs, vital signs, ECG, laboratory tests

    Time frame: through study completion (14 days)

    all AEs, physical examinations, vital signs (heart rate, blood pressure, respiratory rate, and temperature), 12-lead ECGs, and laboratory safety tests (hematology, serum chemistry, coagulation, and urinalysis).

  3. ln-transformed Cavg of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA following multiple doses of Epanova™ compared to multiple doses of Vascepa®

    Time frame: Days 1 and 24

    The systemic exposure of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA following multiple doses of Epanova™ compared to multiple doses of Vascepa® will be assessed by analyzing the ln-transformed Cavg. In addition to an ANOVA, an analysis of covariance (ANCOVA) including the baseline value as a covariate will be performed.

  4. ln-transformed Cmax,ss of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA following multiple doses of Epanova™ compared to multiple doses of Vascepa®

    Time frame: Days 1 and 24

    The systemic exposure of baseline-adjusted (primary analysis) and unadjusted (secondary analysis) total EPA, total DHA, and total EPA+DHA following multiple doses of Epanova™ compared to multiple doses of Vascepa® will be assessed by analyzing the ln-transformed Cmax,ss. In addition to an ANOVA, an analysis of covariance (ANCOVA) including the baseline value as a covariate will be performed.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: ECLIPSEIII

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 8, 2016
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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