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

NCT02859129 | Completed Phase 1

• 1 other identifier: OM-EPA-009
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertriglyceridemia

Keywords

Epanova; omega-3 carboxylic acids; Vascepa; Eicosapentaenoic acid ethyl ester; Crestor; rosuvastatin

Outcome Measures

Primary Outcomes (2)

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

  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.

  Days 1 and 24

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

  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.

  Days 1 and 24

Secondary Outcomes (3)

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

  Days 1 and 24

• 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

  Days 1 and 24

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

  Days 1 and 24

Other Outcomes (4)

• 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®

  Days 1 and 24

• AEs, vital signs, ECG, laboratory tests

  through study completion (14 days)

• 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®

  Days 1 and 24

Study Arms (4)

Rosuvastatin

EXPERIMENTAL

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

Drug: rosuvastatin 40 mg tablet

Epanova®

EXPERIMENTAL

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)

Epanova® + Crestor®

EXPERIMENTAL

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

Vascepa®

ACTIVE COMPARATOR

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

Interventions

rosuvastatin 40 mg tablet DRUG

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

Also known as: Crestor

Rosuvastatin

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)

Also known as: omega-3 carboxylic acids

Epanova®

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

Also known as: omega-3 carboxylic acids, Crestor

Epanova® + 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).

Also known as: icosapent ethyl

Vascepa®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Celerion

Neptune City, New Jersey, 07753, United States

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Rosuvastatin Calcium; Tablets; eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Michael D Davidson, MD

  Omthera Pharmaceuticals/AstraZeneca

  STUDY DIRECTOR

• Sandra M Connolly, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: August 8, 2016
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

US (1)