The study was designed to investigate the absolute bioavailability, and the effects of food on the bioavailability, of two oral formulations of CK-1827452.
Pharmacokinetic data from this study demonstrated absolute oral bioavailability of approximately 100% for each of the three conditions of oral administration.
These data suggest relatively little variability in oral absorption between patients and therefore predictable plasma levels with oral administration of CK-1827452, which may help to ensure the safety and tolerability of CK-1827452 during chronic oral administration. Oral absorption while fasting was rapid for the liquid solution and immediate-release solid formulation. All four conditions of administration were well tolerated, and there were no serious adverse events.
“We are pleased that this study demonstrated such high levels of bioavailability in humans for CK-1827452 when administered orally,” stated David Morgans Jr, Cytokinetics’ senior vice president of Preclinical R&D.
“These data are consistent with what we had observed in preclinical models and will inform further formulation development and manufacturing activities in 2007.”