A PK and PD Study of Two Formulations of Omega-3 One Gram Capsules (PK/PD)

A Pharmacokinetic and Pharmacodynamic Study of Two Formulations of Omega-3 One Gram Capsules After Single and Multi-Dose Administrations Under Fed Conditions

Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3 medication comparator.

Study Overview

• Status: Completed
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Drug: Drug Omega 3; Drug: Drug Omega-3 Comparator

Detailed Description

The primary objective is to determine the comparative bioavailability and pharmacodynamics effects of single and multiple doses of MAT9001 versus an active omega-3 medication comparator.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M1S 3V6
      • Pharma Medica Reserach Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects must fulfil all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:

1. Adult male or female subject, 18-70 years of age, inclusive.
2. Light- or non-smoking, male and female subjects, 18 to 70 years of age. Note: subjects that regularly smoke greater than 10 cigarettes per day will not be considered light-smokers and should not be included. Additionally, the use of any cigars, pipes, vapor inhalers or any other tobacco containing product is prohibited within 6 months prior to drug administration.
3. Body mass index (BMI) ≥ 19 and ≤ 40 (kg/m2).
4. No clinically significant findings in vital signs measurements. The acceptable range for seated systolic blood pressure is 90-150 mmHg and for diastolic blood pressure is 50-95 mmHg.
5. No clinically significant abnormal laboratory values that, in the opinion of the investigator, would compromise the subject's safety or the integrity of the study results.
6. Either have: elevated triglyceride levels (2.26 to 4.52 mmol/L [200 to 400 mg/dL]), or · triglyceride levels 2.26 to 3.95 mmol/L (200 to 350 mg/dL) and are on stable statin therapy.
7. Total cholesterol levels ≤ 7.75 mmol/L (≤ 300 mg/dL).
8. Hemoglobin ≥ 135 g/L for males or ≥ 120 g/L for females at screening.
9. No clinically significant findings in a 12-lead electrocardiogram (ECG)
10. Have no significant diseases.
11. Willing to use an acceptable, effective method of contraception.
12. Be informed of the nature of the study and give written consent prior to any study procedure.
13. Have no clinically significant findings from a physical examination.

Exclusion Criteria:

Subjects may be excluded from the study if there is evidence of any of the following criteria at screening, check-in, or at any time during the study, as appropriate:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurological, or psychiatric disease in the opinion of the PI.
2. Personal or familial history of bleeding disorder(s), thromboembolic disease, clinical GI bleeding, or any history of GI surgery except uncomplicated appendectomy or cholecystectomy, or colorectal surgery for polyps, nonmalignant tumors, or diverticula.
3. Positive urine drug/alcohol testing at screening or check-in.
4. Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
5. History or presence of alcoholism or drug abuse within the past 2 years.
6. Known sensitivity or allergy to fish, shellfish, gelatin or omega-3 products.
7. Subject is a female who is pregnant or lactating.
8. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to drug administration
9. Donation of blood or significant blood loss within 56 days prior to check- in.
10. Participation in another clinical trial within 30 days prior drug administration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug Omega 3; 4g (4 capsules) once a day, administered with food Other name MAT9001	Drug: Drug Omega 3; 4 g (4 capsules) once a day, administered with food; Other Names: MAT9001
Active Comparator: Drug Omega 3 Comparator; 4g (4 capsules) once a day, administered with food Other name Omega 3 Active Comparator	Drug: Drug Omega-3 Comparator; 4 g (4 capsules) once a day, administered with food; Other Names: Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioavailability comparison after single and multiple doses over a 24 hour period at day 1 and day 14	Area under the plasma concentration curve versus time curve (AUC0-tau) versus time curve (AUC0-tau) for both treatments measured over the 24 hour period on day 1 and day 14 [ Time Frame: 14 days ]	14 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of baseline changes of triglycerides and other related lipid protein parameter levels over 14 days	To compare the change from baseline triglyceride and other related lipid/lipoprotein parameter levels between:· MAT9001 and an active omega-3 medication comparator; after multi-dose administrations in subjects under fed conditions	14 Days

Collaborators and Investigators

• Sponsor: Matinas Biopharma, Inc
• Investigators: Study Director: Eric Chen, MD, Pharma Medica Research, Inc.

Publications and helpful links

General Publications

• Maki KC, Bobotas G, Dicklin MR, Huebner M, Keane WF. Effects of MAT9001 containing eicosapentaenoic acid and docosapentaenoic acid, compared to eicosapentaenoic acid ethyl esters, on triglycerides, lipoprotein cholesterol, and related variables. J Clin Lipidol. 2017 Jan-Feb;11(1):102-109. doi: 10.1016/j.jacl.2016.10.010. Epub 2016 Oct 18.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (Estimate): December 5, 2014

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: MB-70001