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Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03078738
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Omeicos Therapeutics GmbH

February 16, 2017
March 13, 2017
March 13, 2017
February 8, 2017
February 2018   (Final data collection date for primary outcome measure)
Safety assessed by frequency and nature of treatment-emergent adverse events [ Time Frame: From Day 1 to Day 21 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects
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.

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.
Interventional
Phase 1
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
Healthy Volunteers
  • 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
  • Other: Matching Placebo
    Microcrystalline cellulose
    Other Name: Microcrystalline cellulose
  • 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
    Intervention: Drug: OMT-28
  • Experimental: OMT-28-MAD
    Multiple ascending dose of dose levels 1 - 4 of OMT-28 over 14 days Oral, healthy young male
    Intervention: Drug: OMT-28
  • Experimental: OMT-28- Food Effect
    Single dose of OMT-28 Oral, healthy young male
    Intervention: Drug: OMT-28
  • Experimental: OMT-28-Gender
    Single dose of OMT-28 Oral, healthy non-child bearing potential female
    Intervention: Drug: OMT-28
  • Placebo Comparator: Placebo-SAD
    Single dose levels 1 - 5 of matching placebo, Oral, healthy young male
    Intervention: Other: Matching Placebo
  • Placebo Comparator: Placebo MAD
    Multiple dose levels 1 - 4 of matching placebo over 14 days Oral, healthy young male
    Intervention: Other: Matching Placebo
  • Placebo Comparator: Placebo-Gender
    Single dose of matching Placebo Oral, healthy non-child bearing potential female
    Intervention: Other: Matching Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
92
Same as current
February 12, 2018
February 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years to 45 Years   (Adult)
Yes
Contact: Luciana Summo, PhD 3094894818 l.summo@omeicos.com
Germany
 
 
NCT03078738
OMT28-C0101
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Omeicos Therapeutics GmbH
Omeicos Therapeutics GmbH
Not Provided
Principal Investigator: Frank Schaumann, Dr. med CRS-Mönchengladbach
Omeicos Therapeutics GmbH
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP