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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: OMT-28; Other: Matching Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Monchengladbach, Germany
    • CRS-Mönchengladbach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OMT-28-SAD; OMT-28-SAD, Single ascending dose levels 1 - 3 of OMT-28 (15, 30, 60 mg) Oral, healthy young male	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
EXPERIMENTAL: OMT-28-MAD; Multiple ascending dose of dose levels 1 - 3 of OMT-28 over 14 days (4, 12, 36 mg) Oral, healthy young male	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
EXPERIMENTAL: OMT-28- Food Effect; Single dose of OMT-28 (4 mg) Oral, healthy young male	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
EXPERIMENTAL: OMT-28-Gender; Single dose of OMT-28 (4 mg) Oral, healthy non-child bearing potential female	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
PLACEBO_COMPARATOR: Placebo-SAD; Single dose levels 1 - 3 of matching placebo, Oral, healthy young male	Other: Matching Placebo; Microcrystalline cellulose; Other Names: Microcrystalline cellulose
PLACEBO_COMPARATOR: Placebo MAD; Multiple dose levels 1 - 3 of matching placebo over 14 days Oral, healthy young male	Other: Matching Placebo; Microcrystalline cellulose; Other Names: Microcrystalline cellulose
PLACEBO_COMPARATOR: Placebo-Gender; Single dose of matching Placebo Oral, healthy non-child bearing potential female	Other: Matching Placebo; Microcrystalline cellulose; Other Names: Microcrystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety assessed by frequency and nature of treatment-emergent adverse events	From Day 1 to Day 21

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK) measured by AUC0-t of OMT-28 in plasma in the SAD	From Day 1 to Day 21
Pharmacokinetics (PK) measured by AUC0-∞ of OMT-28 in plasma in the SAD	From Day 1 to Day 21
Pharmacokinetics (PK) measured by Cmax of OMT-28 in plasma in the SAD	From Day 1 to Day 21
Pharmacokinetics (PK) measured by AUC0-24h of OMT-28 in plasma after single dosing in the SAD	From Day 1 to Day 28
Pharmacokinetics (PK) measured by AUC0-τ after multiple dosing on Day 7 and 14 in the MAD	From Day 7 to Day 14
Pharmacokinetics (PK) of OMT28 measured Cmax after multiple dosing on Day 7 and 14 in the MAD	From Day 7 to Day 14
Pharmacokinetics (PK) in Food Effect and Gender Part measured by AUC0-t of OMT-28 in plasma	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	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	From Day 1 to Day 21 (Gender) and Day 28 (F&E)
Change-from-baseline of QTcF (∆QTcF)	From baseline to Day 28
Change from-baseline of heart rate	From baseline to Day 28
Change from-baseline of PR interval in ECG	From baseline to Day 28
Change from-baseline of QRS interval (∆HR, ∆PR and ∆QRS)	From baseline to Day 28

Collaborators and Investigators

• Sponsor: Omeicos Therapeutics GmbH
• Investigators: Principal Investigator: Frank Schaumann, Dr. med, CRS-Mönchengladbach

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2017
• Primary Completion (ACTUAL): March 12, 2018
• Study Completion (ACTUAL): March 12, 2018

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (ACTUAL): March 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Cardiovascular; SAD; MAD; OMT-28; First-in-Man
• Other Study ID Numbers: OMT28-C0101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No