Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078738
• Other study ID #: OMT28-C0101
• Status: Completed
• Phase: Phase 1
• Start date: February 8, 2017
• Est. completion date: March 12, 2018

Study information

• Verified date: September 2018
• Source: Omeicos Therapeutics GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 12, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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:
• Matching Placebo
Microcrystalline cellulose

Locations

Country	Name	City	State
Germany	CRS-Mönchengladbach	Monchengladbach

Sponsors (1)

Lead Sponsor	Collaborator
Omeicos Therapeutics GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by frequency and nature of treatment-emergent adverse events		From Day 1 to Day 21
Secondary	Pharmacokinetics (PK) measured by AUC0-t of OMT-28 in plasma in the SAD		From Day 1 to Day 21
Secondary	Pharmacokinetics (PK) measured by AUC0-8 of OMT-28 in plasma in the SAD		From Day 1 to Day 21
Secondary	Pharmacokinetics (PK) measured by Cmax of OMT-28 in plasma in the SAD		From Day 1 to Day 21
Secondary	Pharmacokinetics (PK) measured by AUC0-24h of OMT-28 in plasma after single dosing in the SAD		From Day 1 to Day 28
Secondary	Pharmacokinetics (PK) measured by AUC0-t after multiple dosing on Day 7 and 14 in the MAD		From Day 7 to Day 14
Secondary	Pharmacokinetics (PK) of OMT28 measured Cmax after multiple dosing on Day 7 and 14 in the MAD		From Day 7 to Day 14
Secondary	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)
Secondary	Pharmacokinetics (PK) in Food Effect and Gender Part measured by AUC0-8 of OMT-28 in plasma		From Day 1 to Day 21 (Gender) and Day 28 (F&E)
Secondary	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)
Secondary	Change-from-baseline of QTcF (?QTcF)		From baseline to Day 28
Secondary	Change from-baseline of heart rate		From baseline to Day 28
Secondary	Change from-baseline of PR interval in ECG		From baseline to Day 28
Secondary	Change from-baseline of QRS interval (?HR, ?PR and ?QRS)		From baseline to Day 28