PHARMACOKINETICS AND SAFETY OF ORAL POSACONAZOLE (SCH56592) IN SUBJECTS AT HIGH RISK FOR INVASIVE FUNGAL DISEASE.  (PROTOCOL Nº P05615 PHASE1B)

Not Applicable

• Conditions: -B99 Other and unspecified infectious diseases; Other and unspecified infectious diseases; B99

• Registration Number: PER-110-10
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

• 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

Exclusion Criteria

• 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
<br>Outcome name:Posaconazole steady-state concentrations of posaconazole in the plasma reached after regular and repeated dosing were used to estimate pharmacokinetic (PK) parameters for each participant where Cavg was defined as area under the plasma concentration versus time curve divided by the dosing interval.<br><br>Blood samples for the assessment of Cavg were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.<br><br><br>Measure:Average Concentration (Cavg) of Posaconazole Tablet<br>Timepoints:Predose on Day 1 up to 24 hours postdose on Day 8<br>