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NCT Number: NCT03078738

Safety and Pharmacokinetic Study 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.

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Key information

Conditions

Healthy Volunteers Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS-Mönchengladbach

Mönchengladbach, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OMT-28

Drug

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 names: 17,18-epoxyeicosatetraenoic acid analog

Matching Placebo

Other

Microcrystalline cellulose

Other names: Microcrystalline cellulose

Primary outcomes

  1. Safety assessed by frequency and nature of treatment-emergent adverse events

    Time frame: From Day 1 to Day 21

Secondary outcomes

  1. Pharmacokinetics (PK) measured by AUC0-t of OMT-28 in plasma in the SAD

    Time frame: From Day 1 to Day 21

  2. Pharmacokinetics (PK) measured by AUC0-∞ of OMT-28 in plasma in the SAD

    Time frame: From Day 1 to Day 21

  3. Pharmacokinetics (PK) measured by Cmax of OMT-28 in plasma in the SAD

    Time frame: From Day 1 to Day 21

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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)

  9. 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)

  10. Change-from-baseline of QTcF (∆QTcF)

    Time frame: From baseline to Day 28

  11. Change from-baseline of heart rate

    Time frame: From baseline to Day 28

  12. Change from-baseline of PR interval in ECG

    Time frame: From baseline to Day 28

  13. Change from-baseline of QRS interval (∆HR, ∆PR and ∆QRS)

    Time frame: From baseline to Day 28

Sponsors and collaborators

Lead sponsor

Omeicos Therapeutics GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2017
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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