Cytokinetics Announces the Initiation of Third Phase IIa Clinical Trial of CK-1827452
News Sep 15, 2008
Cytokinetics, Incorporated announced the initiation of its third Phase IIa clinical trial evaluating CK-1827452, a novel cardiac myosin activator being developed by the company for the potential treatment of patients with either acutely decompensated or chronic heart failure. CK-1827452 is the subject of a Collaboration and Option Agreement between Cytokinetics and Amgen Inc.
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 280 ng/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 twelve patients.