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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310022
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Matinas Biopharma, Inc

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

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: Drug Omega 3 Drug: Drug Omega-3 Comparator Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic and Pharmacodynamic Study of Two Formulations of Omega-3 One Gram Capsules After Single and Multi-Dose Administrations Under Fed Conditions
Study Start Date : November 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Active Comparator




Primary Outcome Measures :
  1. Bioavailability comparison after single and multiple doses over a 24 hour period at day 1 and day 14 [ Time Frame: 14 Days ]
    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 ]


Secondary Outcome Measures :
  1. Comparison of baseline changes of triglycerides and other related lipid protein parameter levels over 14 days [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310022


Locations
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Canada, Ontario
Pharma Medica Reserach Inc
Toronto, Ontario, Canada, M1S 3V6
Sponsors and Collaborators
Matinas Biopharma, Inc
Investigators
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Study Director: Eric Chen, MD Pharma Medica Research, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matinas Biopharma, Inc
ClinicalTrials.gov Identifier: NCT02310022    
Other Study ID Numbers: MB-70001
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases