The trial has studied healthy volunteers in a single, escalating dose format, to determine the safety, dose range and pharmacokinetics of the drug candidate. The results demonstrate significant biological effect on clotting time and a desirable safety profile following oral administration.
MPC-0920 was shown to be absorbed with a very close correlation between the plasma concentration of drug in plasma and an effect on blood clotting as measured by an increase in pro-thrombin time. There were no apparent drug-related adverse events during the study.
The primary objectives of the Phase I trial were to examine the safety and pharmacokinetics of MPC-0920 and a secondary objective was to study the biological activity of MPC-0920. Unlike most Phase I studies, this study showed that a significant biological activity was present and highly correlated to the observed plasma concentration. Myriad intends to aggressively seek a commercial partner for MPC-0920 rather than pursuing further regulatory development independently.