NCT03078738

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Omeicos Therapeutics GmbH · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-02-08
• Primary completion: 2018-03-12
• Completion: 2018-03-12
• First posted: 2017-03-13
• Last updated: 2018-09-28

Locations

1 site across 1 country: Germany