Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects
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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: NCT03078738 |
Recruitment Status :
Completed
First Posted : March 13, 2017
Last Update Posted : September 28, 2018
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Condition or disease | Intervention/treatment | Phase |
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Healthy Volunteers | Drug: OMT-28 Other: Matching Placebo | Phase 1 |
This first-in-human study will be carried out in one study center involving multiple steps. Up to 100 healthy male and female subjects will be enrolled. The study consists of 4 parts:
- a single ascending dose (SAD) part
- a multiple ascending dose (MAD) part
- a single dose, double cross-over food effect (FE) part.
- a single dose gender effect part (female subjects group) The safety and PK data will be evaluated by the DSMC after each cohort to decide on further dose escalation.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | SAD, MAD and Gender parts: double blind randomized. Food Effect part: open label, crossover design |
Primary Purpose: | Treatment |
Official Title: | A First-in-Human Randomized, Double-blind, Placebo-controlled, Fed-fasted, Gender, Single and Multiple Ascending Oral Dose Study, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OMT-28 in Healthy Subjects |
Actual Study Start Date : | February 8, 2017 |
Actual Primary Completion Date : | March 12, 2018 |
Actual Study Completion Date : | March 12, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: OMT-28-SAD
OMT-28-SAD, Single ascending dose levels 1 - 3 of OMT-28 (15, 30, 60 mg) Oral, healthy young male
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Drug: OMT-28
OMT-28 is a fully synthetic small molecule that belongs to the family of 17,18-epoxyeicosatetraenoic acids (17,18-EEQ) analogs, a natural metabolite of the omega-3 fatty acid eicosapentaenoic acid (EPA).
Other Name: 17,18-epoxyeicosatetraenoic acid analog |
Experimental: OMT-28-MAD
Multiple ascending dose of dose levels 1 - 3 of OMT-28 over 14 days (4, 12, 36 mg) Oral, healthy young male
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Drug: OMT-28
OMT-28 is a fully synthetic small molecule that belongs to the family of 17,18-epoxyeicosatetraenoic acids (17,18-EEQ) analogs, a natural metabolite of the omega-3 fatty acid eicosapentaenoic acid (EPA).
Other Name: 17,18-epoxyeicosatetraenoic acid analog |
Experimental: OMT-28- Food Effect
Single dose of OMT-28 (4 mg) Oral, healthy young male
|
Drug: OMT-28
OMT-28 is a fully synthetic small molecule that belongs to the family of 17,18-epoxyeicosatetraenoic acids (17,18-EEQ) analogs, a natural metabolite of the omega-3 fatty acid eicosapentaenoic acid (EPA).
Other Name: 17,18-epoxyeicosatetraenoic acid analog |
Experimental: OMT-28-Gender
Single dose of OMT-28 (4 mg) Oral, healthy non-child bearing potential female
|
Drug: OMT-28
OMT-28 is a fully synthetic small molecule that belongs to the family of 17,18-epoxyeicosatetraenoic acids (17,18-EEQ) analogs, a natural metabolite of the omega-3 fatty acid eicosapentaenoic acid (EPA).
Other Name: 17,18-epoxyeicosatetraenoic acid analog |
Placebo Comparator: Placebo-SAD
Single dose levels 1 - 3 of matching placebo, Oral, healthy young male
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Other: Matching Placebo
Microcrystalline cellulose
Other Name: Microcrystalline cellulose |
Placebo Comparator: Placebo MAD
Multiple dose levels 1 - 3 of matching placebo over 14 days Oral, healthy young male
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Other: Matching Placebo
Microcrystalline cellulose
Other Name: Microcrystalline cellulose |
Placebo Comparator: Placebo-Gender
Single dose of matching Placebo Oral, healthy non-child bearing potential female
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Other: Matching Placebo
Microcrystalline cellulose
Other Name: Microcrystalline cellulose |
- Safety assessed by frequency and nature of treatment-emergent adverse events [ Time Frame: From Day 1 to Day 21 ]
- Pharmacokinetics (PK) measured by AUC0-t of OMT-28 in plasma in the SAD [ Time Frame: From Day 1 to Day 21 ]
- Pharmacokinetics (PK) measured by AUC0-∞ of OMT-28 in plasma in the SAD [ Time Frame: From Day 1 to Day 21 ]
- Pharmacokinetics (PK) measured by Cmax of OMT-28 in plasma in the SAD [ Time Frame: From Day 1 to Day 21 ]
- Pharmacokinetics (PK) measured by AUC0-24h of OMT-28 in plasma after single dosing in the SAD [ Time Frame: From Day 1 to Day 28 ]
- Pharmacokinetics (PK) measured by AUC0-τ after multiple dosing on Day 7 and 14 in the MAD [ Time Frame: From Day 7 to Day 14 ]
- Pharmacokinetics (PK) of OMT28 measured Cmax after multiple dosing on Day 7 and 14 in the MAD [ Time Frame: From Day 7 to Day 14 ]
- Pharmacokinetics (PK) in Food Effect and Gender Part measured by AUC0-t of OMT-28 in plasma [ Time Frame: From Day 1 to Day 21 (Gender) and Day 28 (F&E) ]
- Pharmacokinetics (PK) in Food Effect and Gender Part measured by AUC0-∞ of OMT-28 in plasma [ Time Frame: From Day 1 to Day 21 (Gender) and Day 28 (F&E) ]
- Pharmacokinetics (PK) of OMT28 in Food Effect and Gender Part measured by Cmax of OMT-28 in plasma [ Time Frame: From Day 1 to Day 21 (Gender) and Day 28 (F&E) ]
- Change-from-baseline of QTcF (∆QTcF) [ Time Frame: From baseline to Day 28 ]
- Change from-baseline of heart rate [ Time Frame: From baseline to Day 28 ]
- Change from-baseline of PR interval in ECG [ Time Frame: From baseline to Day 28 ]
- Change from-baseline of QRS interval (∆HR, ∆PR and ∆QRS) [ Time Frame: From baseline to Day 28 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- In general good physical health as determined by medical and surgical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests
- Normal blood pressure (Systolic Blood Pressure (SBP) between 100 to 140 mmHg (both inclusive); Diastolic Blood Pressure (DBP) ≥55, ≤89 mmHg) measured after 5 min rest in supine position.
- SAD, MAD, and FE part: male of 18 to 45 years (inclusive) of age.
- Gender effect part: female of 18 to 45 years (inclusive) of age.
Exclusion Criteria:
- More than moderate smoker (> 10 cigarettes/day).
- More than moderate alcohol consumption (> 35 g of ethanol regularly per day or > 245 g regularly per week).
- Use of any medication
- One or more key safety laboratory parameters out of normal range Gender effect part Pregnant or breastfeeding women and of childbearing potential Previous assignment to treatment during this study.

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): NCT03078738
Germany | |
CRS-Mönchengladbach | |
Monchengladbach, Germany |
Principal Investigator: | Frank Schaumann, Dr. med | CRS-Mönchengladbach |
Responsible Party: | Omeicos Therapeutics GmbH |
ClinicalTrials.gov Identifier: | NCT03078738 |
Other Study ID Numbers: |
OMT28-C0101 |
First Posted: | March 13, 2017 Key Record Dates |
Last Update Posted: | September 28, 2018 |
Last Verified: | September 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
OMT-28 Atrial Fibrillation SAD |
MAD First-in-Man Cardiovascular |