A recently completed phase I clinical trial in healthy volunteers evaluated an intravenous formulation of the drug candidate. Pharmacokinetic data from that trial suggest that the half-life of CK-1827452 is sufficiently long to support development of an oral alternative.
Andrew Wolff, Cytokinetics’ senior vice president of clinical R&D and chief medical officer, stated, “The data from this trial will inform oral formulation development. Our plan is to finalize an oral formulation in order to evaluate a treatment paradigm unavailable with current inotropic agents which can only be administered intravenously.”
Cytokinetics expects that CK-1827452 will enter an international phase II clinical trials program in patients with heart failure in the second half of 2006. This program is planned to evaluate the compound in a variety of patients, including those with stable heart failure, inducible ischemia, impaired renal function and acute heart failure.