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

NCT02209766 | Completed Phase 1 Results

• 1 other identifier: D5881C00005
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; D5884; Japanese; Caucasian

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)

  Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)

  from first dosing (Day1) until follow-up (Day25)

Secondary Outcomes (12)

• Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose

  Day1-3, 4, 7, 11, 14, 17-18 and 25

• Tmax in Plasma Baseline-adjusted Total EPA, Single Dose

  Day1-3, 4, 7, 11, 14, 17-18 and 25

• Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose

  Day1-3, 4, 7, 11, 14, 17-18 and 25

• Tmax in Plasma Baseline-adjusted Total DHA, Single Dose

  Day1-3, 4, 7, 11, 14, 17-18 and 25

• Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose

  Day1-3, 4, 7, 11, 14, 17-18 and 25

Study Arms (2)

D5884

EXPERIMENTAL

D5884 capsule, Per oral(po)

Drug: D5884

Placebo

PLACEBO COMPARATOR

Placebo capsule, po

Drug: Placebo

Interventions

D5884 DRUG

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

D5884

Placebo DRUG

1. st cohort: Dose 1(2g) D5884(n=3) in Japanese 2. nd cohort: Dose 2(4g) D5884(n=3) in Japanese

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male, 20 to 45 years of age (inclusive)
• 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
• 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
• No habitual use of drug(s) and non-tobacco/nicotine-containing products for a minimum of 6 months prior to dosing
• 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.
• Mean fasting Triglyceride(TG) at -4 and -2 weeks of \<150 mg/dL, and %TG change of \<30% between Weeks -4 and -2

You may not qualify if:

• Participation in another clinical study with an investigational product(IP) during the 4 months prior to enrolment
• Past history of psychological or physical disorder which may affect the objectives of this study, in the opinion of the PI
• 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)
• A history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease
• 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.)
• A positive test for syphilis, human immunodeficiency virus, hepatitis B surface antigen or hepatitis C virus antibodies.
• Had used fish oil, other EPA- and/or DHA-containing supplements within 2 months of the planned time of admission
• Current evidence, or a history of alcoholism or drug abuse within the 2 years prior to admission
• A known sensitivity or allergy to soybeans, fish and/or shellfish
• A hypersensitivity or idiosyncratic reaction to compounds related to EPA and/or DHA
• Had used any prescription medication within 14 days prior to admission
• 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
• 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
• 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
• Had donated plasma within 7 days prior to admission

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

CPC Clinical Trial Hospital

Kagoshima, Kagoshima-ken, 8900081, Japan

Location

Results Point of Contact

• Title: Hideo Negi
• Organization: CO RIA TA, R&D

H.Negi@astrazeneca.com

+81 6 4803 3533

Study Officials

• Hiroyuki Fukase, MD

  CPC Clinical Trial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 6, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 17, 2016
• Results First Posted: May 17, 2016

Record last verified: 2016-04

Locations

JP (1)