A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(Omega-3-carboxylic Acids)
Condition: Healthy
Intervention: D5884; Placebo
Intervention description: 1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian; st cohort: Dose 1(2g) D5884(n=3) in Japanese
nd cohort: Dose 2(4g) D5884(n=3) in Japanese
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 86.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; D5884; Japanese; Caucasian

Summary:

      The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884
      following administration of single and multiple doses in healthy male Japanese subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult male, 20 to 45 years of age (inclusive)

          2. Body mass index (BMI) ≥18.5 and ≤25 kg/m2 for Japanese subjects, ≥18.5 and ≤30 kg/m2
             for Caucasian subjects. BMI calculations to be conducted on height and weight values
             obtained at Visit 1

          3. Medically healthy with clinically insignificant screening results (eg, laboratory
             profile, medical history, ECGs, physical examination). Haemoglobin has to be ≥ the
             lower limit of the study site reference range, 12-lead ECG must have QT interval
             corrected for heart rate using Fridericia's formula(QTcF) >340 msec and <450 msec

          4. No habitual use of drug(s) and non-tobacco/nicotine-containing products for a minimum
             of 6 months prior to dosing

          5. Subjects must be willing and able to give written informed consent by signing an
             Institutional Review Board(IRB)-approved informed consent form (ICF) prior to
             admission to this study and follow the restrictions and procedures outlined for the
             study.

          6. Mean fasting Triglyceride(TG) at -4 and -2 weeks of <150 mg/dL, and %TG change of <30%
             between Weeks -4 and -2

        Exclusion Criteria:

          1. Participation in another clinical study with an investigational product(IP) during the
             4 months prior to enrolment

          2. Past history of psychological or physical disorder which may affect the objectives of
             this study, in the opinion of the PI

          3. An individual who has abnormal laboratory values (ie, suggesting hepatic, renal,
             cardiovascular or endocrine disorders or diabetes mellitus), or an inappropriate
             current or past medical history for participation based on the decision of the
             principal investigator(PI)

          4. A history or presence of significant cardiovascular, pulmonary, hepatic, renal,
             haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or
             psychiatric disease

          5. A positive urine drug/alcohol test at screening or admission (Visit 3, Day -1). (The
             drug test includes testing for phencyclidine, benzodiazepine, cocaine, amphetamines,
             cannabis, opiates, barbiturates and tricyclic anti-depressants. The alcohol test is an
             alcohol breath assessment.)

          6. A positive test for syphilis, human immunodeficiency virus, hepatitis B surface
             antigen or hepatitis C virus antibodies.

          7. Had used fish oil, other EPA- and/or DHA-containing supplements within 2 months of the
             planned time of admission

          8. Current evidence, or a history of alcoholism or drug abuse within the 2 years prior to
             admission

          9. A known sensitivity or allergy to soybeans, fish and/or shellfish

         10. A hypersensitivity or idiosyncratic reaction to compounds related to EPA and/or DHA

         11. Had used any prescription medication within 14 days prior to admission

         12. Had used any over-the-counter (OTC) medication, including herbal products (bromelains,
             danshen, dong quai [Angelica sinensis], garlic, ginko biloba, ginseng, and St. John's
             wort), within the 7 days prior to admission

         13. Had used any drugs known to significantly inhibit [strong or moderate] or induce liver
             enzymes involved in drug metabolism [cytochrome P450]) within 30 days prior to
             admission

         14. Had donated blood or had had significant blood loss in excess of 200 mL within 1 month
             prior to admission or in excess of 400 mL within 3 months prior to admission

         15. Had donated plasma within 7 days prior to admission

         16. History of drug abuse or past history of alcohol abuse or habit of taking
             nicotine-containing product(s) on a daily basis

         17. Those who have difficulty in giving blood during blood sampling via the peripheral
             vein

         18. Any potential subjects who are considered as not eligible for the study in the opinion
             of the PI and/or the sub-investigator