fungal prophylaxis pharmacokinetics
Conditions
Interventions
- 10 subjects (group A) will start with posaconazole 300mg IV BID on day 1,
followed by 300mg IV QD on days 2-7, followed by 300mg PO QD on days 8-12,
followed by 200mg PO QD on days 13-16.
- 10 su
fungal infections
mucositis
pharmacokinetics
posaconazole
Sponsors
Afdeling Apotheek
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations. 2. Subject is at least 18 years of age on the day of providing informed consent. 3. Patient receives immunosuppressive therapy for acute GVHD, (non)myeloablative or reduced intensity conditioning regimens for SCT, or remission induction chemotherapy for AML/MDS. 4. In case of acute GVHD grade II-IV, patient has received less than 1 week of immunosuppressive therapy. 5. If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant. 6. Has an ALAT
Exclusion criteria
Exclusion criteria: 1. Documented history of sensitivity to medicinal products or excipients similar to those found in the posaconazole preparation. 2. Relevant history or presence of cardiovascular disorders (specific QTc time prolongation). 3. Inability to understand the nature of the trial and the procedures required. 4. Any sign or symptoms of invasive fungal disease or the use of antifungal drugs within the previous month. 5. Has previously participated in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Data will be analyzed using non-linear mixed effects modeling (NONMEM). NONMEM is a one-stage analysis that simultaneously fixed (e.g. clearance, volume of distribution, covariate effects)and random (e.g. inter- and intra-individual variability and residual error) effects. Since allowance can be made for individual differences, this method can be used with both intensive sampling and sparse data (and in the occasion of missing values: an unbalanced number of data points per patients). Multiple compartment models with first-order or saturable elimination will be tested. Between subject variability (BSV) and, when applicable, between occasion variability (BOV) will be included on all pharmacokinetic parameters. Residual unexplained variability (RUV) will be estimated with additive or proportional error models. The first-order conditional estimation method with interaction will be used. Citrulline will be tested as a binary covariate on bioavailability. Dose linearity | — |
Countries
Belgium
Outcome results
None listed