A Ph1 Study in Healthy Male Japanese and Caucasian After Single and Multiple Doses of D5884(omega-3-carboxylic acids)

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