Pharmacokinetics and Safety of Solid Oral Posaconazole(SCH 56592) in Subjects at High Risk for Invasive Fungal Infections

Posaconazole (POS) is a systemic antifungal oral suspension approved for use as a treatment of refractory invasive fungal infection (rIFI), treatment of oro-pharyngeal thrush (candidiasis) and prevention (prophylaxis) of invasive fungal infection (IFI) in high-risk patients as a result of severe immuno-suppression. This includes those with neutropenia (low white blood cell count) after chemotherapy or patients who have had a bone marrow or stem cell transplant (HSCT) and are having treatment for graft-versus-host (GVHD) condition. It is recommended that Posaconazole (POS) oral liquid suspension is taken several times a day and/or with a high fat meal or nutritional supplement to ensure that the medication is absorbed into the body. Such food intake is difficult to achieve in immuno-compromised, acutely ill patients, particularly patients with active Graft-Versus-Host Disease or patients with leukaemia undergoing acute chemotherapy. A new solid oral formulation of Posaconazole (POS), SCH 056592, has been developed to optimize absorption in patients with limited food intake. It has been designed to release Posaconazole (POS) in the small intestine. This maximises its systemic absorption and overcomes the food-effect limitations of the oral suspension formulation. The purpose of this study is to evaluate the amount of drug absorption and safety of SCH 056592 in a broad population of subjects who would benefit from antifungal prophylaxis and 2) compare these findings with results from other studies to support the selection of a dose for registration of the solid oral formulation.