The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects

Study identifier:OM-EPA-007

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-Label, Randomized, 2-Way Crossover Study to Evaluate the Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects

Medical condition

Hypertriglyceridemia

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Simvastatin, acetylsalicylic acid (ASA), omefas

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Nov 2011

Primary Completion Date: 01 Mar 2012

Study Completion Date: 01 Mar 2012

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2015 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

Subjects must fulfil all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
1. Healthy adult male or female volunteers, 18-55 years of age, inclusive.
2. Body mass index (BMI) ≥ 18 and ≤ 29.9 (kg/m2).
3. Medically healthy with clinically insignificant screening results.
Hemoglobin must be ≥ the lower limit of normal.
4. Continuous non-smokers who haven't used nicotine-containing products for at
least 6 months prior to the first dose.
5. Voluntarily consent to participate in the study and to follow the
restrictions and procedures outlined for the study.
6. Females must be of non-childbearing potential, and have undergone
sterilization procedures at least 6 months prior to the first dose or be
postmenopausal with amenorrhea for at least 2 years prior to first dosing
and follicle stimulating hormone (FSH) serum levels ≥ 40 mIU/mL.

Exclusion Criteria

Subjects may be excluded from the study if there is evidence of any of the following criteria at screening, check-in, or at any time during the study, as appropriate:
1. History or presence of significant cardiovascular, pulmonary, hepatic,
renal, haematological, gastrointestinal (GI), endocrine, immunologic,
dermatologic, neurological, or psychiatric disease in the opinion of the PI.
2. Personal or familial history of bleeding disorder(s), thromboembolic
disease, clinical GI bleeding, or any history of GI surgery except
uncomplicated appendectomy or cholecystectomy, or colorectal surgery for
polyps, nonmalignant tumors, or diverticula.
3. Positive urine drug/alcohol testing at screening or check-in.
4. Positive result for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), or hepatitis C antibodies (HCV).
5. History or presence of alcoholism or drug abuse within the past 2 years.
6. Subject has been on a special diet (for whatever reason) within the 28
days prior to the assigned first dose of study drug or anytime during the
study.
7. Known sensitivity or allergy to soybeans, fish, and/or shellfish.
8. Hypersensitivity or idiosyncratic reaction to compounds related to
simvastatin (i.e., HMG-CoA reductase inhibitors) and/or Epanova® and/or
aspirin.
9. Subject is a female who is pregnant or lactating.
10. Use of any prescription medication within 14 days prior to the first dose.
11. Use of any over-the-counter (OTC) medication, including herbal products (e.g., bromelains, danshen, dong quai [Angelica sinensis], garlic, ginko biloba, ginseng, and St. John's wort, NSAIDs), vitamin K or food supplements (especially omega-3-fatty acids) within the 7 days prior to first dosing.
12. Use of any drugs known to significantly inhibit [strong or moderate] or
induce liver enzymes involved in drug metabolism [CYP P450]) within 30 days
prior to check-in.
13. Donation of blood or significant blood loss within 56 days prior to check-
in.
14. Donation of plasma within 7 days prior to check-in.
15. Participation in another clinical trial within 30 days prior to check-in.

No locations available

Arms	Assigned Interventions
Experimental: Epanova and Simvastatin	Drug: Simvastatin 40 mg (1 tablet) simvastatin once a day Drug: acetylsalicylic acid (ASA) 81 mg aspirin (1 tablet), once a day, co-administered with simvastatin Other Name: aspirin Drug: omefas 4 g (4 capsules) Epanova once a day, co-administered with simvastatin and aspirin Other Name: Epanova
Active Comparator: Simvastatin	Drug: Simvastatin 40 mg (1 tablet) simvastatin once a day Drug: acetylsalicylic acid (ASA) 81 mg aspirin (1 tablet), once a day, co-administered with simvastatin Other Name: aspirin

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Michael H Davidson

Omthera Pharmaceuticals, Inc