Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

NCT03078738 | Completed Phase 1 DMC

• 1 other identifier: OMT28-C0101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  From Day 1 to Day 21

Secondary Outcomes (13)

• 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

Study Arms (7)

OMT-28-SAD

EXPERIMENTAL

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-MAD

EXPERIMENTAL

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- Food Effect

EXPERIMENTAL

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

Drug: OMT-28

OMT-28-Gender

EXPERIMENTAL

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

Drug: OMT-28

Placebo-SAD

PLACEBO COMPARATOR

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

Other: Matching Placebo

Placebo MAD

PLACEBO COMPARATOR

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

Other: Matching Placebo

Placebo-Gender

PLACEBO COMPARATOR

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

Other: Matching Placebo

Interventions

OMT-28 DRUG

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).

Also known as: 17,18-epoxyeicosatetraenoic acid analog

OMT-28- Food Effect; OMT-28-Gender; OMT-28-MAD; OMT-28-SAD

Matching Placebo OTHER

Microcrystalline cellulose

Also known as: Microcrystalline cellulose

Placebo MAD; Placebo-Gender; Placebo-SAD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omeicos Therapeutics GmbH: lead

Study Sites (1)

CRS-Mönchengladbach

Mönchengladbach, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

17,18-epoxy-5,8,11,14-eicosatetraenoic acid; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank Schaumann, Dr. med

  CRS-Mönchengladbach

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: SAD, MAD and Gender parts: double blind randomized. Food Effect part: open label, crossover design
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 13, 2017
• Study Start: February 8, 2017
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)