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

NCT ID: NCT02859129

Last Updated: 2016-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-11-30

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

Detailed 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.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rosuvastatin

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

Group Type: EXPERIMENTAL

rosuvastatin 40 mg tablet

Intervention Type: DRUG

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

Epanova®

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

Group Type: EXPERIMENTAL

Epanova™ QD (2 x 1 g capsules)

Intervention Type: DRUG

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

Epanova® + Crestor®

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Vascepa®

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

rosuvastatin 40 mg tablet

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

Intervention Type: DRUG

Epanova™ QD (2 x 1 g capsules)

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

Crestor; omega-3 carboxylic acids; omega-3 carboxylic acids; Crestor; icosapent ethyl

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael D Davidson, MD

Role: STUDY_DIRECTOR

Omthera Pharmaceuticals/AstraZeneca

Sandra M Connolly, MD

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion

Neptune City, New Jersey, United States

Countries

United States

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4425&filename=OMA_EPA_009_CSR.pdf

CSR Synopsis

Other Identifiers

OM-EPA-009

Identifier Type: -

Identifier Source: org_study_id