None listed
Conditions
Interventions
Posaconazole Type of group
Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. Measure:Average Concentration (Cavg) of Posaconazole Tablet Timepoints:Predose on Day 1 up to 24 hours postdose on Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Cmin was defined as posaconazole trough level immediately before a participant received the dose of posaconazole tablets on the specified day. Trough (Cmin) level blood samples for determination of posaconazole in plasma were collected for all participants on Day 1, Day 2, Day 3, and Day 8. On Day 1, the trough level sample was collected the before the first dose of study drug. On Day 2, trough samples were collected approximately 12 hours after the second dose of study drug was administered on Day 1. On all subsequent days, trough samples were collected approximately 24 hours following the previous days dose of study drug. Measure:Minimum Concentration (Cmin) of Posaconazole Tablet Timepoints:Predose on Day 1 up to 24 hours postdose on Day 8 ; Outcome name:Blood samples for the assessment of Cmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. Measure:Maximum Concentration (Cmax) of Posaconazole Tablet Timepoints:Predose on Day 1 up to 24 hours postdose on Day 8 ; Outcome name:Blood samples for the assessment of Tmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. Measure:Time to Maximum Concentration (Tmax) of Posaconazole Tablet Timepoints:Predose on Day 1 up to 24 hours postdose on Day 8 ; Outcome name:Blood samples for the assessment of CL/F, the rate at which posaconazole was removed from the body, were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose. Measure:Apparent Total Body Clearance (CL/F) for Posaconazole Tablet Timepoints:Predose on Day 1 up to 24 hours postdose on Day 8 ; Outcome name:Number of Participants Alive at Day 65 Measure:Number of Participants Surviving at Day 65 Timepoints:Day 65 ; Outcome name:AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a s | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed