Trial | NCT03078738  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    omt-28 ...

  • Study Participants

    75
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:

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.
Study Started
Feb 08
2017
Primary Completion
Mar 12
2018
Study Completion
Mar 12
2018
Last Update
Sep 28
2018

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 names: 17,18-epoxyeicosatetraenoic acid analog

Other Matching Placebo

Microcrystalline cellulose

  • Other names: Microcrystalline cellulose

OMT-28-SAD Experimental

OMT-28-SAD, Single ascending dose levels 1 - 3 of OMT-28 (15, 30, 60 mg) Oral, healthy young male

OMT-28-MAD Experimental

Multiple ascending dose of dose levels 1 - 3 of OMT-28 over 14 days (4, 12, 36 mg) Oral, healthy young male

OMT-28- Food Effect Experimental

Single dose of OMT-28 (4 mg) Oral, healthy young male

OMT-28-Gender Experimental

Single dose of OMT-28 (4 mg) Oral, healthy non-child bearing potential female

Placebo-SAD Placebo Comparator

Single dose levels 1 - 3 of matching placebo, Oral, healthy young male

Placebo MAD Placebo Comparator

Multiple dose levels 1 - 3 of matching placebo over 14 days Oral, healthy young male

Placebo-Gender Placebo Comparator

Single dose of matching Placebo Oral, healthy non-child bearing potential female

Criteria 

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.
No Results Posted