Study OPL-0301-201 is intended to generate efficacy and safety data of OPL-0301 in participants with post-myocardial infarction (MI) left ventricular dysfunction (LVD)
OPL-0301 is intended to address the disease state of post-myocardial infarction (MI) left ventricular dysfunction (LVD). MI is a manifestation of atherosclerotic coronary artery disease, the pathogenesis of which is closely associated with vascular and endothelial dysfunction, and inflammation. Acute MI leads to acute LVD, which often persists, leading to poor cardiovascular outcomes. The therapeutic hypothesis is that these effects mediated by Sphingosine-1 Phosphate 1 (S1P1) receptor agonism with OPL-0301 will reduce infarct size and benefit post-MI left ventricular function, thereby supporting improved cardiovascular outcomes in this patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
Pharmaceutical form: Hard gelatin capsule; Route of administration: Oral
Infarct size as determined by cardiac magnetic resonance (CMR) at Day 90
To evaluate the effects of OPL-0301 versus placebo on infarct size in adults with post-myocardial infarction left ventricular dysfunction at day 90
Time frame: 90 days
Change in infarct size by cardiac magnetic resonance (CMR) from initial CMR assessment to Day 90
To evaluate the effects of OPL-0301 versus placebo on the change in infarct size in adults with post-myocardial infarction left ventricular dysfunction
Time frame: Initial to 90 days
Adverse events (AEs) and Serious adverse events (SAEs)
To assess the effects of OPL-0301 on safety and tolerability
Time frame: Baseline to 120 days
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