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Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

NCT03078738 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-09-28

No results posted yet for this study

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 and gender effects of OMT-28 to guide dosing for Phase II trials.

Conditions

  • Healthy Volunteers

Interventions

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

Matching Placebo

Microcrystalline cellulose

Sponsors & Collaborators

  • Omeicos Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Frank Schaumann, Dr. med · CRS-Mönchengladbach

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2018-03-12
Completion
2018-03-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078738 on ClinicalTrials.gov