Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

Omeicos Therapeutics GmbH75 enrolled

Overview

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: 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

OMT-28DRUG

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).

Matching PlaceboOTHER

Microcrystalline cellulose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CRS-Mönchengladbach

Mönchengladbach, Germany

Outcomes

Primary Outcomes

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

Time frame: From Day 1 to Day 21

Secondary Outcomes

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

Time frame: From Day 1 to Day 21

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

Time frame: From Day 1 to Day 21

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

Time frame: From Day 1 to Day 21

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

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

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

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)

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)

Pharmacokinetics (PK) of OMT28 in Food Effect and Gender Part measured by Cmax of OMT-28 in plasma

Data from ClinicalTrials.gov

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