This open-label Phase IIa clinical trial is designed to evaluate an intravenous formulation of CK-1827452 in patients with stable heart failure undergoing clinically indicated coronary angiography in the cardiac catheterization laboratory.
The primary objective of this trial is to evaluate the potential effects of CK-1827452 on myocardial efficiency, defined as the ratio of ventricular performance to myocardial oxygen consumption. The secondary objectives of this trial are to measure the potential effects of CK-1827452 on ventricular performance, myocardial oxygen consumption, hemodynamics, pressure-volume relationships and systolic ejection time.
Preclinical studies have suggested that CK-1827452 increases ventricular performance in the absence of substantial changes in myocardial oxygen consumption, thereby increasing myocardial efficiency. This trial of CK-1827452 is designed to investigate this finding further in patients with stable heart failure. The protocol for this clinical trial provides for the enrollment of two cohorts of patients.
The first cohort, consisting of six patients, will undergo a dose escalation Phase, beginning with a target plasma concentration of approximately 280ng/ml. Based on the tolerability and pharmacodynamic effects observed in this initial cohort, the investigators will select a single dosing regimen to administer to the second cohort, consisting of 12 patients.
Andrew Wolff, chief medical officer of Cytokinetics, said: “This clinical trial is a significant step towards a fuller understanding of the effects of CK-1827452 in patients with heart failure. Because of its novel mechanism, this drug candidate has the potential to demonstrate properties in this trial that could differentiate it from existing inotropic drugs.”