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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Hypertriglyceridemia

Treatments: Drug: rosuvastatin 40 mg tablet; Drug: Epanova™ QD (2 x 1 g capsules); Drug: Multiple (20) oral doses of 2 g Vascepa® every 12 hours; Drug: Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02859129

OM-EPA-009

Details and patient eligibility

About

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

Full description

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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 4 patient groups

Rosuvastatin

Experimental group

Description:

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

Treatment:

Drug: rosuvastatin 40 mg tablet

Epanova®

Experimental group

Description:

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

Treatment:

Drug: Epanova™ QD (2 x 1 g capsules)

Epanova® + Crestor®

Experimental group

Description:

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

Treatment:

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

Vascepa®

Active Comparator group

Description:

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

Treatment:

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