Pharmacokinetics and Safety of Solid Oral Posaconazole(SCH 56592) in Subjects at High Risk for Invasive Fungal Infections
- Conditions
- High Risk for Invasive Fungal Infection due to:- Expected neutropenia (low white blood cell count) due to chemotherapy for Acute Myelogenous Leukaemia (AML) or Myelodysplastic Syndrome (MDS)High Risk for Invasive Fungal Infection due to:- Hematopoietic stem cell transplant (HSCT) recipients undergoing treatment for graft-versus-host disease (GVHD)High Risk for Invasive Fungal Infection due to:- Expected neutropenia (low white blood cell count) due to chemotherapy for Acute Myelogenous Leukaemia (AML) or Myelodysplastic Syndrome (MDS)- Hematopoietic stem cell transplant (HSCT) recipients undergoing treatment for graft-versus-host disease (GVHD)Infection - Other infectious diseases
- Registration Number
- ACTRN12611000364976
- Lead Sponsor
- Schering-Plough Pty limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 160
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the drug absorption (Pharmacokinetic) profile of SCH 056592 in adults who have a weakened immune system because of a low white blood cell count (neutropenia) after chemotherapy or patients who have had a bone marrow or stem cell transplant (SCT) and are on immunosuppressant drugs to prevent rejection. Assessment will be through the collection of trough (low) blood samples.[Assessed at Day 1 (before the first dose of study drug), Day 2 (approx. 12 hours after the second dose of study drug given on Day 1), and then approx. 24 hours following the previous day?s dose of study drug at Day 3, Day 8 (+/-1 day), Day 14 (+/-1 day), Day 21 (+/-1 day), and Day 28 (+/-1 day).]
- Secondary Outcome Measures
Name Time Method