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

NCT02310022 | Completed Phase 1

• 1 other identifier: MB-70001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of baseline changes of triglycerides and other related lipid protein parameter levels over 14 days

  14 Days

Study Arms (2)

Drug Omega 3

EXPERIMENTAL

4g (4 capsules) once a day, administered with food Other name MAT9001

Drug: Drug Omega 3

Drug Omega 3 Comparator

ACTIVE COMPARATOR

4g (4 capsules) once a day, administered with food Other name Omega 3 Active Comparator

Drug: Drug Omega-3 Comparator

Interventions

Drug Omega 3 DRUG

4 g (4 capsules) once a day, administered with food

Also known as: MAT9001

Drug Omega 3

Drug Omega-3 Comparator DRUG

4 g (4 capsules) once a day, administered with food

Also known as: Active Comparator

Drug Omega 3 Comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female subject, 18-70 years of age, inclusive.
• 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.
• Body mass index (BMI) ≥ 19 and ≤ 40 (kg/m2).
• 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.
• 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.
• 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.
• Total cholesterol levels ≤ 7.75 mmol/L (≤ 300 mg/dL).
• Hemoglobin ≥ 135 g/L for males or ≥ 120 g/L for females at screening.
• No clinically significant findings in a 12-lead electrocardiogram (ECG)
• Have no significant diseases.
• Willing to use an acceptable, effective method of contraception.
• Be informed of the nature of the study and give written consent prior to any study procedure.
• Have no clinically significant findings from a physical examination.

You may not qualify if:

• 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:
• 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.
• 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.
• Positive urine drug/alcohol testing at screening or check-in.
• Positive result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
• History or presence of alcoholism or drug abuse within the past 2 years.
• Known sensitivity or allergy to fish, shellfish, gelatin or omega-3 products.
• Subject is a female who is pregnant or lactating.
• Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to drug administration
• Donation of blood or significant blood loss within 56 days prior to check- in.
• Participation in another clinical trial within 30 days prior drug administration.

Sponsors & Collaborators

• Matinas Biopharma, Inc: lead

Study Sites (1)

Pharma Medica Reserach Inc

Toronto, Ontario, M1S 3V6, Canada

Location

Related Publications (1)

• 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.

  PMID: 28391875 DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

MAT9001

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eric Chen, MD

  Pharma Medica Research, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: December 5, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: August 1, 2016
• Last Updated: October 12, 2020

Record last verified: 2020-10

Locations

CA (1)