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

Matinas BioPharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hypertriglyceridemia

Treatments: Drug: Drug Omega 3; Drug: Drug Omega-3 Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02310022

MB-70001

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Drug Omega 3

Experimental group

Description:

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

Treatment:

Drug: Drug Omega 3

Drug Omega 3 Comparator

Active Comparator group

Description:

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

Treatment:

Drug: Drug Omega-3 Comparator