Pharmacokinetics and Safety of Solid Oral Posaconazole(SCH 56592) in Subjects at High Risk for Invasive Fungal Infections (Phase 1b; Protocol No. P05615)

Schering-Plough Pty limited0 个研究点目标入组 160 人开始时间: 2011年4月8日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

发起方

Schering-Plough Pty limited