Healthy VolunteersPhase 1NCT03078738
Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects
A Phase 1 study testing OMT-28 in people with Healthy Volunteers, run by Omeicos Therapeutics GmbH at 1 site in Germany.
Trial summary
The aim of this first-in-human study is to assess the safety, tolerability, PK and exploratory pharmacodynamics (PD) of single and multiple oral ascending doses of OMT-28 in healthy male subjects to support further clinical development of OMT-28 in the indication of atrial fibrillation (AF) and to obtain data on food… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- OMT-28
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- 8 Feb 2017to 12 Mar 2018
- Phase
- Phase 1
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The aim of this first-in-human study is to assess the safety, tolerability, PK and exploratory pharmacodynamics (PD) of single and multiple oral ascending doses of OMT-28 in healthy male subjects to support further clinical development of OMT-28 in the indication of atrial fibrillation (AF) and to obtain data on food and gender effects of OMT-28 to guide dosing for Phase II trials.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- OMT-28, Matching Placebo
- Keywords
- OMT-28, Atrial Fibrillation, SAD, MAD, First-in-Man, Cardiovascular
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMT-28Drug
Also called 17,18-epoxyeicosatetraenoic acid analog
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).
Matching PlaceboOther
Also called Microcrystalline cellulose
Microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| OMT-28-SAD | Experimental | OMT-28-SAD, Single ascending dose levels 1 - 3 of OMT-28 (15, 30, 60 mg) Oral, healthy young male Receives: Drug: OMT-28 |
| OMT-28-MAD | Experimental | Multiple ascending dose of dose levels 1 - 3 of OMT-28 over 14 days (4, 12, 36 mg) Oral, healthy young male Receives: Drug: OMT-28 |
| OMT-28- Food Effect | Experimental | Single dose of OMT-28 (4 mg) Oral, healthy young male Receives: Drug: OMT-28 |
| OMT-28-Gender | Experimental | Single dose of OMT-28 (4 mg) Oral, healthy non-child bearing potential female Receives: Drug: OMT-28 |
| Placebo-SAD | Placebo comparator | Single dose levels 1 - 3 of matching placebo, Oral, healthy young male Receives: Other: Matching Placebo |
| Placebo MAD | Placebo comparator | Multiple dose levels 1 - 3 of matching placebo over 14 days Oral, healthy young male Receives: Other: Matching Placebo |
| Placebo-Gender | Placebo comparator | Single dose of matching Placebo Oral, healthy non-child bearing potential female Receives: Other: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by frequency and nature of treatment-emergent adverse events
Measured: From Day 1 to Day 21
Secondary outcomes (13)
Pharmacokinetics (PK) measured by AUC0-t of OMT-28 in plasma in the SAD
Measured: From Day 1 to Day 21
Pharmacokinetics (PK) measured by AUC0-∞ of OMT-28 in plasma in the SAD
Measured: From Day 1 to Day 21
Pharmacokinetics (PK) measured by Cmax of OMT-28 in plasma in the SAD
Measured: From Day 1 to Day 21
Pharmacokinetics (PK) measured by AUC0-24h of OMT-28 in plasma after single dosing in the SAD
Measured: From Day 1 to Day 28
Pharmacokinetics (PK) measured by AUC0-τ after multiple dosing on Day 7 and 14 in the MAD
Measured: From Day 7 to Day 14
Pharmacokinetics (PK) of OMT28 measured Cmax after multiple dosing on Day 7 and 14 in the MAD
Measured: From Day 7 to Day 14
Pharmacokinetics (PK) in Food Effect and Gender Part measured by AUC0-t of OMT-28 in plasma
Measured: 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
Measured: 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
Measured: From Day 1 to Day 21 (Gender) and Day 28 (F&E)
Change-from-baseline of QTcF (∆QTcF)
Measured: From baseline to Day 28
Change from-baseline of heart rate
Measured: From baseline to Day 28
Change from-baseline of PR interval in ECG
Measured: From baseline to Day 28
Change from-baseline of QRS interval (∆HR, ∆PR and ∆QRS)
Measured: From baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start8 Feb 2017
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeicos Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Schaumann, Dr. med, Principal investigator, CRS-Mönchengladbach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078738
- Sponsor's protocol ID
- OMT28-C0101
- Status last verified
- Sep 2018
- First submitted
- 16 Feb 2017
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03078738
- Acronym / sponsor ID
- OMT28-C0101
- Conditions
- Healthy Volunteers
- Keywords
- OMT-28, Atrial Fibrillation, SAD, MAD, First-in-Man, Cardiovascular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Omeicos Therapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 13 Mar 2017 (actual)
- 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.
The aim of this first-in-human study is to assess the safety, tolerability, PK and exploratory pharmacodynamics (PD) of single and multiple oral ascending doses of OMT-28 in healthy male subjects to support further clinical development of OMT-28 in the indication of atrial fibrillation (AF) and to obtain data on food and gender effects of OMT-28 to guide dosing for Phase II trials.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| OMT-28-SAD | Experimental | Drug: OMT-28OMT-28-SAD, Single ascending dose levels 1 - 3 of OMT-28 (15, 30, 60 mg) Oral, healthy young male |
| OMT-28-MAD | Experimental | Drug: OMT-28Multiple ascending dose of dose levels 1 - 3 of OMT-28 over 14 days (4, 12, 36 mg) Oral, healthy young male |
| OMT-28- Food Effect | Experimental | Drug: OMT-28Single dose of OMT-28 (4 mg) Oral, healthy young male |
| OMT-28-Gender | Experimental | Drug: OMT-28Single dose of OMT-28 (4 mg) Oral, healthy non-child bearing potential female |
| Placebo-SAD | Placebo comparator | Other: Matching PlaceboSingle dose levels 1 - 3 of matching placebo, Oral, healthy young male |
| Placebo MAD | Placebo comparator | Other: Matching PlaceboMultiple dose levels 1 - 3 of matching placebo over 14 days Oral, healthy young male |
| Placebo-Gender | Placebo comparator | Other: Matching PlaceboSingle dose of matching Placebo Oral, healthy non-child bearing potential female |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| OMT-28Also: 17,18-epoxyeicosatetraenoic acid analogOMT-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). | Drug | OMT-28- Food Effect, OMT-28-Gender, OMT-28-MAD, OMT-28-SAD |
| Matching PlaceboAlso: Microcrystalline celluloseMicrocrystalline cellulose | Other | Placebo MAD, Placebo-Gender, Placebo-SAD |
Primary outcome
Safety assessed by frequency and nature of treatment-emergent adverse events
Time frame: From Day 1 to Day 21
13 secondary outcomes
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
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 28 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Frank Schaumann, Dr. med principal investigator
CRS-Mönchengladbach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OMT-28 in people with Healthy Volunteers, run by Omeicos Therapeutics GmbH at 1 site in Germany.
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 4 inclusion and 4 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 28 Sep 2018. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Safety assessed by frequency and nature of treatment-emergent adverse events (time frame: From Day 1 to Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2018.