Fungal infection / aspergillose
Conditions
Interventions
Placing a venous cathether for blood sampling.
Single dose of posaconazol, adminstered according to SPC.
Sampling of a total of 60ml blood (including, PK curve, lab and hematology)
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects BMI: o obese groups: subject must have a BMI >=35 kg/m2 at the time of inclusion, o non-obese group: subject must have a BMI >=18.5 and
Exclusion criteria
Exclusion criteria: 1. Documented history of sensitivity to medicinal products or excipients similar to those found in the posaconazole preparation; 2. History of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration); 3. Use of medication that has known relevant interaction with study drug as determined by the investigator up to 1 weeks prior to study drug administration. 4. Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks prior to study drug administration; 5. Blood transfusion within 8 weeks prior to study drug administration; 6. Any other sound medical, psychiatric and/or social reason as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A farmacokinetic model using Non Linear Mixed Effects Modelling (NONMEM). Model validation using bootstrap method. The final model will be used for Monte Carlo simulation for multiple-dosing regimens and higher dosages. | — |
Countries
Netherlands
Outcome results
None listed