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Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

This study is currently recruiting participants.
Verified March 2017 by Omeicos Therapeutics GmbH
Sponsor:
ClinicalTrials.gov Identifier:
NCT03078738
First Posted: March 13, 2017
Last Update Posted: March 13, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Omeicos Therapeutics GmbH
  Purpose
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.

Condition Intervention Phase
Healthy Volunteers Drug: OMT-28 Other: Matching Placebo Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Omeicos Therapeutics GmbH:

Primary Outcome Measures:
  • Safety assessed by frequency and nature of treatment-emergent adverse events [ Time Frame: From Day 1 to Day 21 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 92
Actual Study Start Date: February 8, 2017
Estimated Study Completion Date: February 12, 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMT-28-SAD
OMT-28-SAD, Single ascending dose levels 1 - 5 of OMT-28 (15, 45, 120, 240, 360 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-MAD
Multiple ascending dose of dose levels 1 - 4 of OMT-28 over 14 days 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- Food Effect
Single dose of OMT-28 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 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 - 5 of matching placebo, Oral, healthy young male
Other: Matching Placebo
Microcrystalline cellulose
Other Name: Microcrystalline cellulose
Placebo Comparator: Placebo MAD
Multiple dose levels 1 - 4 of matching placebo over 14 days Oral, healthy young male
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
Other: Matching Placebo
Microcrystalline cellulose
Other Name: Microcrystalline cellulose

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:

  1. a single ascending dose (SAD) part
  2. a multiple ascending dose (MAD) part
  3. a single dose, double cross-over food effect (FE) part.
  4. 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.
  Eligibility

Information from the National Library of Medicine

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
Criteria

Inclusion Criteria:

  1. In general good physical health as determined by medical and surgical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests
  2. 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.
  3. SAD, MAD, and FE part: male of 18 to 45 years (inclusive) of age.
  4. Gender effect part: female of 18 to 45 years (inclusive) of age.

Exclusion Criteria:

  1. More than moderate smoker (> 10 cigarettes/day).
  2. More than moderate alcohol consumption (> 35 g of ethanol regularly per day or > 245 g regularly per week).
  3. Use of any medication
  4. 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.
  Contacts and Locations
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): NCT03078738


Contacts
Contact: Luciana Summo, PhD 3094894818 l.summo@omeicos.com

Locations
Germany
CRS-Mönchengladbach Recruiting
Monchengladbach, Germany
Contact: Frank Schaumann, Dr med         
Contact    0800 0216100    probandeninfo.mg@crs-group.de   
Sponsors and Collaborators
Omeicos Therapeutics GmbH
Investigators
Principal Investigator: Frank Schaumann, Dr. med CRS-Mönchengladbach
  More Information

Responsible Party: Omeicos Therapeutics GmbH
ClinicalTrials.gov Identifier: NCT03078738     History of Changes
Other Study ID Numbers: OMT28-C0101
First Submitted: February 16, 2017
First Posted: March 13, 2017
Last Update Posted: March 13, 2017
Last Verified: March 2017
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

Keywords provided by Omeicos Therapeutics GmbH:
OMT-28
Atrial Fibrillation
SAD
MAD
First-in-Man
Cardiovascular