Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-08

Study Completion Date

2018-03-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

SAD, MAD and Gender parts: double blind randomized. Food Effect part: open label, crossover design

Study Groups

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OMT-28-SAD

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

Group Type EXPERIMENTAL

OMT-28

Intervention Type 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).

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

Group Type EXPERIMENTAL

OMT-28

Intervention Type 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).

OMT-28- Food Effect

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

Group Type EXPERIMENTAL

OMT-28

Intervention Type 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).

OMT-28-Gender

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

Group Type EXPERIMENTAL

OMT-28

Intervention Type 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).

Placebo-SAD

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

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type OTHER

Microcrystalline cellulose

Placebo MAD

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

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type OTHER

Microcrystalline cellulose

Placebo-Gender

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

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type OTHER

Microcrystalline cellulose

Interventions

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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).

Intervention Type DRUG

Matching Placebo

Microcrystalline cellulose

Intervention Type OTHER

Other Intervention Names

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17,18-epoxyeicosatetraenoic acid analog Microcrystalline cellulose

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes