Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: OMT-28; Other: Matching Placebo

• Registration Number: NCT03078738
• Lead Sponsor: Omeicos Therapeutics GmbH

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.

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 Timeline

• Study Start: 2017-02-08
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-13
• Primary Completion: 2018-03-12
• Study Completion: 2018-03-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
OMT-28-Gender	OMT-28	Single dose of OMT-28 (4 mg) Oral, healthy non-child bearing potential female
OMT-28-MAD	OMT-28	Multiple ascending dose of dose levels 1 - 3 of OMT-28 over 14 days (4, 12, 36 mg) Oral, healthy young male
Placebo-SAD	Matching Placebo	Single dose levels 1 - 3 of matching placebo, Oral, healthy young male
OMT-28- Food Effect	OMT-28	Single dose of OMT-28 (4 mg) Oral, healthy young male
OMT-28-SAD	OMT-28	OMT-28-SAD, Single ascending dose levels 1 - 3 of OMT-28 (15, 30, 60 mg) Oral, healthy young male
Placebo MAD	Matching Placebo	Multiple dose levels 1 - 3 of matching placebo over 14 days Oral, healthy young male
Placebo-Gender	Matching Placebo	Single dose of matching Placebo Oral, healthy non-child bearing potential female

Primary Outcome Measures

Name	Time	Method
Safety assessed by frequency and nature of treatment-emergent adverse events	From Day 1 to Day 21

Secondary Outcome Measures

Name	Time	Method
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
Pharmacokinetics (PK) of OMT28 measured Cmax after multiple dosing on Day 7 and 14 in the MAD	From Day 7 to Day 14
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)
Pharmacokinetics (PK) in Food Effect and Gender Part measured by AUC0-∞ of OMT-28 in plasma	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	From Day 1 to Day 21 (Gender) and Day 28 (F&E)
Change-from-baseline of QTcF (∆QTcF)	From baseline to Day 28
Change from-baseline of heart rate	From baseline to Day 28
Change from-baseline of PR interval in ECG	From baseline to Day 28
Change from-baseline of QRS interval (∆HR, ∆PR and ∆QRS)	From baseline to Day 28
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

Trial Locations

Locations (1)

CRS-Mönchengladbach; 🇩🇪 Monchengladbach, Germany