None listed
Conditions
Brief summary
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.
Interventions
Day 1: Two doses of 300mg SCH 056592 administered orally. The two doses of SCH 056592 will be given 12 hours apart.
Day 2 to 28: 300mg SCH 056592 administered orally once daily.
Sponsors
Schering-Plough Pty limited
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Weighs more than 34 kg and of any race 2. Must be able to tolerate the administration of oral tablet medication. 3. Anticipated or documented prolonged neutropenia (absolute neutrophil count [ANC] <500/mm3 to [0.5 x 109/L]) at Baseline and likely to last for at least 7 days due to: a. Standard intensive induction chemotherapy, for a new diagnosis of Acute Myelogenous Leukaemia (AML); b. Reinduction chemotherapy for Acute Myelogenous Leukaemia (AML) in first relapse; or c. myelosuppressive induction therapy for myelodysplastic syndromes (MDS) 4. Additional disease definition which may replace condition noted in Inclusion Criterion No. 3. Hematopoietic progenitor cell transplant subjects receiving immunosuppressive therapy for prevention or treatment of graft-versus-host disease 5. Must be free of any clinically significant disease (other than the primary hematologic disease) that would interfere with the administration of study medication or study evaluations.
Exclusion criteria
1. Must not have a history of type I hypersensitivity or idiosyncratic reactions to azole agents. 2. Must not have moderate or severe liver dysfunction at Baseline. 3. Must not have an electrocardiogram (ECG) with a prolonged QTc interval (QTc greater than 500 msec). 4. Must not have taken posaconazole within 10 days prior to study enrolment. 5. Must not have taken prohibited medications prior to study entry. 6. Must not have received systemic antifungal therapy (oral, intravenous, or inhaled) within 30 days of study enrolment for reasons other than antifungal prophylaxis. 7. Must not have a known (including a possible, probable, or proven fungal infection per EORTC/MSG criteria) or suspected invasive or systemic fungal infection at Baseline. 8. Must not have gastric Graft-Versus-Host Disease (GVHD) Grade 2 or greater.
Outcome results
None listed