PER-110-10已完成未知
PHARMACOKINETICS AND SAFETY OF ORAL POSACONAZOLE (SCH56592) IN SUBJECTS AT HIGH RISK FOR INVASIVE FUNGAL DISEASE. (PROTOCOL Nº P05615 PHASE1B)
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 90（—）
入选标准
- •Body weight >34 kg (75 lb) and of any race/ethnicity
- •Able to swallow oral tablets whole
- •Anticipated (likely to develop within 3-5 days) or documented neutropenia due to chemotherapy, chemotherapy for a new diagnosis of acute myelogenous leukemia (AML), or AML in first relapse; myelodysplastic syndromes (MDS) in transformation to AML; allogeneic hematopoietic stem cell transplant (HSCT) participants in the pre-engraftment period or in the post-engraftment period if they are receiving immunosuppressive therapy for graft versus host disease
排除标准
- •Female must not be pregnant, must not intend to become pregnant during the study, and must not be nursing
- •History of hypersensitivity to azoles
- •Moderate or severe liver dysfunction defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than three times the upper limit of normal (ULN), AND a total bilirubin level greater than two times the ULN
- •Electrocardiogram (ECG) with corrected QTc interval greater than 500 msec
- •Posaconazole within 10 days before study enrollment
- •Receipt of systemic antifungal therapy within 30 days of study enrollment for reasons other than antifungal prophylaxis
- •Evidence of known or suspected invasive or systemic fungal infection at baseline
- •Known or suspected history of Gilbert´s disease
- •Creatinine clearance levels below 30 mL/min
研究者
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