HypertriglyceridemiaPhase 1/2PK/PDNCT02310022
A PK and PD Study of Two Formulations of Omega-3 One Gram Capsules
A Phase 1/2 study testing Drug Omega 3 and Drug Omega-3 Comparator in people with Hypertriglyceridemia, run by Matinas Biopharma, Inc at 1 site in Canada.
Trial summary
Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3 medication comparator. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Drug Omega 3 and Drug Omega-3 Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Aug 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must fulfil all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3 medication comparator.
Read the 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.
- Conditions
- Hypertriglyceridemia
- Being tested
- Drug Omega 3, Drug Omega-3 Comparator
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Omega 3Drug
Also called MAT9001
4 g (4 capsules) once a day, administered with food
Drug Omega-3 ComparatorDrug
Also called Active Comparator
4 g (4 capsules) once a day, administered with food
| Study group | Role | What they receive |
|---|---|---|
| Drug Omega 3 | Experimental | 4g (4 capsules) once a day, administered with food Other name MAT9001 Receives: 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 Receives: Drug: Drug Omega-3 Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ]
Measured: 14 Days
Secondary outcomes (1)
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
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matinas Biopharma, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Chen, MD, Study director, Pharma Medica Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310022
- Sponsor's protocol ID
- MB-70001
- Acronym
- PK/PD
- Status last verified
- Oct 2020
- First submitted
- 14 Nov 2014
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28391875
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02310022
- Acronym / sponsor ID
- PK/PD / MB-70001
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Matinas Biopharma, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative bioavailability and pharmacodynamics effects of MAT9001 versus an active omega-3 medication 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Omega 3 | Experimental | Drug: Drug Omega 34g (4 capsules) once a day, administered with food Other name MAT9001 |
| Drug Omega 3 Comparator | Active comparator | Drug: Drug Omega-3 Comparator4g (4 capsules) once a day, administered with food Other name Omega 3 Active Comparator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must fulfil all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug Omega 3Also: MAT90014 g (4 capsules) once a day, administered with food | Drug | Drug Omega 3 |
| Drug Omega-3 ComparatorAlso: Active Comparator4 g (4 capsules) once a day, administered with food | Drug | Drug Omega 3 Comparator |
Primary outcome
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 ]
1 secondary outcome
Comparison of baseline changes of triglycerides and other related lipid protein parameter levels over 14 days
Time frame: 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Derived from this study: PubMed 28391875Maki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Chen, MD study director
Pharma Medica Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Drug Omega 3 and Drug Omega-3 Comparator in people with Hypertriglyceridemia, run by Matinas Biopharma, Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability comparison after single and multiple doses over a 24 hour period at day 1 and day 14 (time frame: 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.