PHARMACOKINETICS AND SAFETY OF ORAL POSACONAZOLE (SCH56592) IN SUBJECTS AT HIGH RISK FOR INVASIVE FUNGAL DISEASE. (PROTOCOL Nº P05615 PHASE1B)
- Conditions
- -B99 Other and unspecified infectious diseasesOther and unspecified infectious diseasesB99
- Registration Number
- PER-110-10
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 5
• 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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method