Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT03078738
• Recruitment Status: Completed
• First Posted: March 13, 2017
• Last Update Posted: September 28, 2018
• Sponsor: Omeicos Therapeutics GmbH
• Information provided by (Responsible Party): Omeicos Therapeutics GmbH

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: OMT-28; Other: Matching Placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: SAD, MAD and Gender parts: double blind randomized. Food Effect part: open label, crossover design
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: February 8, 2017
• Actual Primary Completion Date: March 12, 2018
• Actual Study Completion Date: March 12, 2018

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Microcrystalline cellulose
Placebo Comparator: Placebo-Gender; Single dose of matching Placebo Oral, healthy non-child bearing potential female	Other: Matching Placebo; Microcrystalline cellulose; Other Name: Microcrystalline cellulose

Outcome Measures

Primary Outcome Measures :

1. Safety assessed by frequency and nature of treatment-emergent adverse events [ Time Frame: From Day 1 to Day 21 ]

Secondary Outcome Measures :

1. Pharmacokinetics (PK) measured by AUC0-t of OMT-28 in plasma in the SAD [ Time Frame: From Day 1 to Day 21 ]
2. Pharmacokinetics (PK) measured by AUC0-∞ of OMT-28 in plasma in the SAD [ Time Frame: From Day 1 to Day 21 ]
3. Pharmacokinetics (PK) measured by Cmax of OMT-28 in plasma in the SAD [ Time Frame: From Day 1 to Day 21 ]
4. 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 ]
5. 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 ]
6. 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 ]
7. 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) ]
8. 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) ]
9. Pharmacokinetics (PK) of OMT28 in Food Effect and Gender Part measured by Cmax of OMT-28 in plasma [ Time Frame: From Day 1 to Day 21 (Gender) and Day 28 (F&E) ]
10. Change-from-baseline of QTcF (∆QTcF) [ Time Frame: From baseline to Day 28 ]
11. Change from-baseline of heart rate [ Time Frame: From baseline to Day 28 ]
12. Change from-baseline of PR interval in ECG [ Time Frame: From baseline to Day 28 ]
13. Change from-baseline of QRS interval (∆HR, ∆PR and ∆QRS) [ Time Frame: From baseline to Day 28 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Germany

CRS-Mönchengladbach

Monchengladbach, Germany

Sponsors and Collaborators

Omeicos Therapeutics GmbH

Investigators

• Principal Investigator: Frank Schaumann, Dr. med; CRS-Mönchengladbach

More Information

• Responsible Party: Omeicos Therapeutics GmbH
• ClinicalTrials.gov Identifier: NCT03078738 History of Changes
• Other Study ID Numbers: OMT28-C0101
• First Posted: March 13, 2017
• Last Update Posted: September 28, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Omeicos Therapeutics GmbH:

OMT-28; Atrial Fibrillation; SAD; MAD; First-in-Man; Cardiovascular