Clinical trial NCT03078738: Safety and Pharmacokinetic Study of OMT-28 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: OMT-28
Atrial Fibrillation
SAD
MAD
First-in-Man
Cardiovascular
Lead sponsor: Omeicos Therapeutics GmbH
Sponsor class: INDUSTRY
First posted: 2017-03-13
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Safety assessed by frequency and nature of treatment-emergent adverse events
timeFrame: From Day 1 to Day 21
Secondary outcomes:
measure: Pharmacokinetics (PK) measured by AUC0-t of OMT-28 in plasma in the SAD
timeFrame: From Day 1 to Day 21
measure: Pharmacokinetics (PK) measured by AUC0-∞ of OMT-28 in plasma in the SAD
timeFrame: From Day 1 to Day 21
measure: Pharmacokinetics (PK) measured by Cmax of OMT-28 in plasma in the SAD
timeFrame: From Day 1 to Day 21
measure: Pharmacokinetics (PK) measured by AUC0-24h of OMT-28 in plasma after single dosing in the SAD
timeFrame: From Day 1 to Day 28
measure: Pharmacokinetics (PK) measured by AUC0-τ after multiple dosing on Day 7 and 14 in the MAD
timeFrame: From Day 7 to Day 14
measure: Pharmacokinetics (PK) of OMT28 measured Cmax after multiple dosing on Day 7 and 14 in the MAD
timeFrame: From Day 7 to Day 14
measure: Pharmacokinetics (PK) in Food Effect and Gender Part measured by AUC0-t of OMT-28 in plasma
timeFrame: From Day 1 to Day 21 (Gender) and Day 28 (F&E)
measure: Pharmacokinetics (PK) in Food Effect and Gender Part measured by AUC0-∞ of OMT-28 in plasma
timeFrame: From Day 1 to Day 21 (Gender) and Day 28 (F&E)
measure: Pharmacokinetics (PK) of OMT28 in Food Effect and Gender Part measured by Cmax of OMT-28 in plasma
timeFrame: From Day 1 to Day 21 (Gender) and Day 28 (F&E)
measure: Change-from-baseline of QTcF (∆QTcF)
timeFrame: From baseline to Day 28
measure: Change from-baseline of heart rate
timeFrame: From baseline to Day 28
measure: Change from-baseline of PR interval in ECG
timeFrame: From baseline to Day 28
measure: Change from-baseline of QRS interval (∆HR, ∆PR and ∆QRS)
timeFrame: From baseline to Day 28
Other outcomes:
Locations:
city: Monchengladbach
country: Germany
facility: CRS-Mönchengladbach
Study officials:
affiliation: CRS-Mönchengladbach
name: Frank Schaumann, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: