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

Study identifier:D5881C00005

ClinicalTrials.gov identifier:NCT02209766

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics in Healthy Male Japanese (Single-blind, Randomized, Placebo-controlled) and Caucasian (Open-label) Subjects After Single and Once Daily Multiple Oral Doses of D5884

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

D5884, Placebo

Sex

Male

Actual Enrollment

Study type

Interventional

Age

20 Years - 45 Years

Date

Study Start Date: 01 Aug 2014

Primary Completion Date: 01 Nov 2014

Study Completion Date: 01 Nov 2014

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Apr 2016 by AstraZeneca

Collaborators

Inclusion and exclusion 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

Location

CPC Clinical Trial Hospital

Kagoshima, KAGOSHIMA, Japan, 8900081

Arms	Assigned Interventions
Experimental: D5884 D5884 capsule, Per oral(po)	Drug: D5884 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
Placebo Comparator: Placebo Placebo capsule, po	Drug: Placebo 1st cohort: Dose 1(2g) D5884(n=3) in Japanese 2nd cohort: Dose 2(4g) D5884(n=3) in Japanese