Comparison of Encapsulated and Non-encapsulated Doxorubicin Pharmacokinetics Following Single Intravenous Administration of ATI-0918, an Encapsulated Liposomal Formulation, and DOXIL® in Female Rats

Purpose:

To compare the pharmacokinetics (PK) of encapsulated and non-encapsulated doxorubicin following a 6
mg/kg IV bolus dose of ATI-0918 or DOXIL® (CAELYX®) in female rats. ATI-0918 is being developed by Azaya Therapeutics to match the physiochemical properties and release specifications of DOXIL®, a doxorubicin hydrochloride liposome injection which is marketed in the United States as DOXIL® and elsewhere as CAELYX®. ATI-0918 in being investigated in a Phase I clinical trial.