A study looking at the effects of a new drug (FDY-501) in patients who have had a heart attack

Phase 1

• Conditions: MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Acute Myocardial Infarction

• Registration Number: EUCTR2017-000047-41-HU
• Lead Sponsor: Faraday Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-08
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. 18-80 year old male subjects
2. 18 to 80 year old female subjects who are not of childbearing potential
3. Accepted for Primary PCI with diagnosis of first STEMI, based on clinical and ECG criteria (ST-elevation at the Jpoint in two contiguous leads with the cut-off points: =0.2 millivolt (mV) in men or =0.15 mV in women in leads V2-V3 and/or =0.1 mV in other leads), within 12 hours of symptom onset
4. Assent/Informed consent to study participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. Previous myocardial infarction
2. Left bundle branch block (LBBB)
3. Previous coronary artery bypass graft surgery (CABG)
4. Major hemodynamic instability or uncontrolled ventricular arrhythmias
5. Known contraindication to CMR (e.g. pacemaker)
6. Patients with known thyroid disease, or known allergy to iodide
7. Subjects with past or current renal impairment requiring dialysis
8. Pregnant or females of childbearing potential
9. Body weight > 120 kg or Body Mass Index (BMI) > 35 kg/m2
10. Use of investigational drugs or devices within 30 days prior to enrollment into the study
11. Life expectancy of less than 1 year due to non-cardiac pathology
12. Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator
or any sub-Investigator would preclude safe completion of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety, efficacy and pharmacokinetics (PK) of 3 dose levels of FDY-5301 compared to placebo in patients presenting with an acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).;Secondary Objective: To examine the effect of FDY-5301 on heart function (assessed using cardiac MRI) and its effect on cardiac biomarkers (e.g. troponin I);Timepoint(s) of evaluation of this end point: 14 days post study drug;Primary end point(s): The primary outcome for this study will be the combined rate and incidence of several arrhythmias of interest for 14 days post study drug. These arrhythmias include ventricular fibrillation, sustained and non-sustained ventricular tachycardia and high degree AV block. Continuous cardiac monitoring will occur for 14 days post PCI by means of wearable patch devices.