A Ph 1 Study of Epanova® in Healthy Chineses

NCT03574142 | Completed Phase 1

• 1 other identifier: D5881C00001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the safety, tolerability, and PK of single and multiple doses of Epanova in healthy male and female Chinese subjects and to allow comparison of these parameters with the Western population studied to date.

Conditions

Healthy Subjects

Keywords

Pharmacokinetics; Safety; Tolerability; Epanova; Omega-3 carboxylic acids; Chinese

Outcome Measures

Primary Outcomes (6)

• 1. Plasma concentrations versus time profile of EPA and DHA

  To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects

  Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20

• 2. Observed maximum plasma concentration (Cmax)

  To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects

  Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20

• 3. Time to reach maximum plasma concentration (tmax)

  To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects

  Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20

• 4. Terminal half-life

  To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects

  Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20

• 5. Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration (AUC0-t)), from time zero to 24 hours (AUC0-24h), and from time zero extrapolated to infinity (AUC)

  To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects

  Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20

• 6. Apparent clearance for parent drug estimated as dose divided by AUC (CL/F)

  To evaluate the PK of single and multiple oral doses of Epanova in Chinese healthy subjects

  Blood sample will be collected on Day-1, Day1(-1h, -5min Pre-dose and 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose),Day2,3,4,7,11,14,16,and Day17 (-5min Pre-dose, 1h, 2h, 3h, 4h, 5h, 6h, 7.5h, 9h, 12h, 16h Post-dose), Day18,19 and Day20

Secondary Outcomes (9)

• Number of subjects with adverse events.

  Adverse event will be collected from Visit 4(Day1) to Visit 23 (Day20).

• Safety as determined by evaluation of blood pressure in mmHg

  Blood presure will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).

• Safety as determined by evaluation of heart beat in beats per minute

  Heart beat will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).

• Safety as determined by evaluation of body temperature in degree Celsius

  Body temperature will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).

• Safety as determined by evaluation of respiratory rate in breaths per minute

  Respiratory rate will be collected from Visit1(any day between Day-28 to Day-2) to Visit23(Day20).

Study Arms (1)

Epanova

EXPERIMENTAL

Epanova® capsule, per oral

Drug: Epanova

Interventions

Epanova DRUG

A single dose of Epanova 4 g will be administered as 4 capsules (each containing 1 g of Epanova) followed by a 72-hour washout period in Chinese healthy subjects. Subsequently, multiple doses of Epanova 4 g will be administered once daily for 14 consecutive days.

Also known as: Omega-3 carboxylic acids

Epanova

Eligibility Criteria

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

You may qualify if:

• Subjects must be willing and able to give written informed consent by signing an IRB-approved Informed Consent Form (ICF) prior to admission to this study and follow the restrictions and procedures outlined for the study.
• Healthy adult males or females as determined by medical history, physical examination, and laboratory tests. Subjects are to be native Chinese, 18 to 45 years of age (inclusive) at the time of consent.
• Body mass index (BMI) ≥19 and ≤26 kg/m2 and weigh at least 50 kg.
• Medically healthy subjects with clinically insignificant screening results (eg, laboratory profiles, medical histories, electrocardiograms \[ECGs\], physical examination). Haemoglobin must be greater than the lower limit of normal. A 12-lead ECG with QTcF \>340 msec and \<450 msec.
• Acceptable supine blood pressure (BP) and heart rate as determined by the investigator (systolic BP ≤140 mm Hg, and diastolic BP ≤90 mm Hg).
• For women of childbearing potential (have not had tubal ligation, hysterectomy or surgical procedure for sterilisation), the results from a serum pregnancy test at screening and at Day -2 must be within the normal range. The subject must also agree to use an acceptable method of contraception throughout the trial. Women with an intact uterus are deemed postmenopausal if they are at least age 45, have had cessation of menses for at least 1 year, and have not taken hormones or oral contraceptives (including oestrogen or hormone replacement therapy) during the past 12 months.

You may not qualify if:

• Past history of psychological or physical disorder.
• An individual who has abnormal laboratory values or an inappropriate current or past medical history for participation based on the PI's decision.
• Has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• Has a positive urine drug/alcohol breath testing at the screening visit or on Day -2.
• Habitual users of drug(s) of abuse.
• Has tested positive for human immunodeficiency virus (HIV), hepatitis B (including surface antigen \[HbsAg\] positive healthy carrier), hepatitis C antibodies (HCV), or syphilis.
• Has used fish oil, other EPA and/or DHA containing supplements within 60 days of admission to the clinic.
• Has a known sensitivity or allergy to soybeans, fish, and/or shellfish.
• Has had a history of hypersensitivity or idiosyncratic reaction to compounds related to Epanova.
• Pregnant or lactating women.
• Those who have difficulty with blood sampling via a peripheral vein.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Beijing, 100029, China

Location

Study Officials

• Yang Lin, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label Study
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: June 29, 2018
• Study Start: June 4, 2018
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)