Fungal infection / Candidiasis
Conditions
Interventions
Placing a venous cathether for blood sampling.
Single dose of micafungin, adminstered according to SPC.
Sampling of a total of 75ml 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 > 40 kg/m2 at the time of inclusion, ;o non-obese group: subject must have a BMI *18.5 and < 25kg/m2 at the time of inclusion.;2. Subject is at least 18 of age on the day of screening and not older than 65 years of age on the day of dosing;;3. If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant;;4. Subject is able and willing to sign the Informed Consent before screening evaluations.;For the non-obese subjects the following additional exclusion criteria apply:;5. Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, hematology and urinalysis testing within 4 weeks prior to study drug administration. Results of biochemistry, hematology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A). If laboratory results are not within the reference ranges, the subject is included based on the investigator*s judgment that the observed deviations are not clinically relevant. This should be clearly recorded;;6. Subject has a normal blood pressure and pulse rate, determined by the investigator;;7. Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to study drug administration.
Exclusion criteria
Exclusion criteria: 1. Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation;;2. History of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration);;3. Inability to understand the nature of the trial and the procedures required;;4. Use of medication that has known interaction with study drug as determined by the investigator up to 4 weeks prior to study drug administration.;For the non-obese subjects the following additional exclusion criteria apply:;5. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs or clinical laboratory determinations;;6. Clinical relevant liver enzymes (alkaline phosphatase, ALT, AST) abnormalities at screening;;7. 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;;8. Blood transfusion within 8 weeks prior to study drug administration;;9. Inability to be venipunctured and/or tolerate venous access;;10. Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), psychiatric disorders, gastro-intestinal disorders, renal disorders, hepatic disorders (Child-Pugh B or C), hormonal disorders (especially diabetes mellitus), coagulation disorders;;11. 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. Een farmacokinetisch model met de hulp van non-lineaire mixed effect modelleren zal de data beschrijven. Met behulp van bootstrap zullen we dit model valideren. The final model will be used for Monte Carlo simulation for multiple-dosing regimens and higher dosages. | — |
Countries
Netherlands
Outcome results
None listed