Invasive Mycoses
Conditions
Interventions
Trade Name: Noxafil 40 mg/ml suspensión oral
Pharmaceutical Form: Oral suspension
INN or Proposed INN: POSACONAZOLE
CAS Number: 171228-49-2
Current Sponsor code: POSACONAZOLE
Other descriptive name:
Sponsors
Fundación Investigación Biomédica Puerta de Hierro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patiens with an indication for antifungal prophylaxis with posaconazole for prolonged severe neutropenia after intensive chemotherapy for acute myeloid leukemia or myelodysplastic syndromes. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Excluded are patients with a history of invasive mycosis, recipients of allogeneic transplantation with or without graft-versus-host disease, with abnormal liver or renal function, prolonged QTc, ECOG >2, pregnant women, or those with some concomitant or previous treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to describe and compare the plasma-level pharmacokinetic profile of two oral formulations of posaconazole, oral suspension and solid tablets, administered sequentially to the same subjects;Secondary Objective: The secondary objectives of the study are to evaluate the gastrointestinal tolerability and treatment experience with both formulations for the patient, to evaluate laboratory safety results and to describe any potential episodes of breakthrough invasive mycosis that may occur during the study treatment.;Primary end point(s): Primary objective of the study is to compare the pharmacokinetic profile of posaconazole oral suspension and solid tablets when administered sequentially to the same subjects. The pharmacokinetic variables are: - Cmin: Minimal concentration - Cmax: Maximal observed concentration - Tmax: Time to Cmax - AUC: Area under the concentration/time curve - Cavg: AUC/dose interval;Timepoint(s) of evaluation of this end point: Pharmacokinetic samples will be taken: - Day 1 and 8 of treatment with both formulations on time 0, +2h, +8h, +24h. - End of treatment, a trough sample before last dose of study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives are to evaluate gastrointestinal tolerability and treatment experience for the subjects with both formulations, to evaluate laboratory toxicity, to register any potential episodes of breakthrough invasive mycosis during study treatment, and to do a final evaluation of survival after end of treatment.;Timepoint(s) of evaluation of this end point: In every study visit (daily in inpatients) and final evaluation 1 week after end of treatment. | — |
Countries
Spain
Contacts
Public ContactDr. Rafael F. Duarte
Fundación Investigación Biomédica Puerta de Hierro
Outcome results
None listed