PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)

Exclusion Criteria

• •Contraindications for CMRI imaging
• •WHO Groups 2, 3, 4 and 5 Pulmonary Hypertension
• •Unrepaired congenital heart defects and significant congenital heart defects (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) repaired less than 1 year prior to Screening (Visit 1) (Group 1 classification of Pulmonary Hypertension)
• •QTcF \> 500 msec
• •Acute myocardial infarction or acute coronary syndrome within the last 90 days
• •Cerebrovascular accident/transient ischemic attack (CVA/TIA) within the last 90 days
• •Hospitalization for left heart failure within the last 90 days
• •Clinically significant aortic or mitral valve disease defined as greater than mild regurgitation or mild stenosis; pericardial constriction; restrictive or constrictive cardiomyopathy; left ventricular dysfunction (LVEF \< 50%); left ventricular outflow obstruction; symptomatic coronary artery disease; autonomic hypotension; or fluid depletion
• •Chronic atrial fibrillation and life-threatening cardiac arrhythmias
• •Personal or family history of congenital prolonged QTc syndrome or sudden or sudden unexpected death due to a cardiac reason
• •Clinically significant anemia
• •Severe hepatic impairment or active chronic hepatitis
• •Receiving intravenous inotropes within 2 weeks prior to Screening
• •History of angina pectoris or other condition that was treated with long or short acting nitrates \<12 weeks of Screening
• •Received prednisone doses \>15mg/day or changes in immunosuppressive medications \< 12 weeks prior to Screening (Visit 1)
• •Recent (within 1 year) history of abusing alcohol or illicit drugs.
• •History of any primary malignancy, with no evidence of disease for at least 5 years
• •Treatment with any investigational drug or device within 30 days or 5 half-lives