Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions
Condition: Relative Bioavailability; AUC; Cmax; Pharmacokinetics
Intervention: D1400147; D14000136; D14000137; Epanova®
Intervention description: Treatment A; Treatment B; Treatment C; Treatment D
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Omega-3-carboxylic acids,; Phase I,; Healthy Subjects,; Pharmacokinetics,; Relative bioavailability

Summary:

      This study is a randomized, open-label, cross-over study in healthy subjects performed at a
      single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of
      the study is to compare the pharmacokinetics (PK) of three different prototype capsule
      formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg
      under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be
      used as basis for choice of formulation for further pharmaceutical development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated written informed consent prior to any study specific
             procedures.

          -  Healthy male and female (non-childbearing potential) subjects aged 18 to 55 years with
             suitable veins for cannulation or repeated venipuncture.

          -  Females must have a negative pregnancy test at screening and on admission to the
             clinical unit, must not be lactating and must be of non-childbearing potential,
             confirmed at screening by fulfilling one of the following criteria:

               -  Post-menopausal, defined as amenorrhea for at least 12 months or more following
                  cessation of all exogenous hormonal treatments, and follicle-stimulating hormone
                  (FSH) levels in the post-menopausal range.

               -  Documentation of irreversible surgical sterilization by hysterectomy, bilateral
                  oophorectomy or bilateral salpingectomy or tubal ligation.

          -  Have a body mass index (BMI) between 18.5 and 29.9 kg/m2 inclusive and weigh at least
             50 kg and no more than 100 kg inclusive.

        Exclusion Criteria:

          -  History of any clinically significant disease or disorder which, in the opinion of the
             investigator, may either put the potential subject at risk because of participation in
             the study, or influences the results or the potential subject's ability to participate
             in the study.

          -  History or presence of gastrointestinal, hepatic or renal disease, or any other
             condition known to interfere with absorption, distribution, metabolism, or excretion
             of drugs.

          -  Current smokers or those who have smoked or used nicotine products within the previous
             3 months.

          -  Consumption of poppy seeds within 7 days of first administration of IMP.

          -  Consumption of fish within 7 days prior to admission to the clinical unit.

          -  Used fish oil, other omega-3 fatty acids (EPA and/or DHA) containing supplements
             within 1 month of admission to the clinical unit.

          -  Have a known sensitivity or allergy to soybeans, fish and/or shellfish.