Morbid Obesity
Conditions
Brief summary
Because micafungin is generally well tolerated and appears to have limited interaction with other drugs, it is a potential important agent in the treatment of invasive fungal infections. Although micafungin is approved for the treatment of invasive candidiasis, dosing guidelines for micafungin in (morbidly) obese patients are not available. Subsequently, the pharmacokinetic profile of micafungin (as well as other echinocandins) in this specific patient population is still largely unknown. To build a valid pharmacokinetic model, obese patients with a BMI ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 100 mg or 200mg micafungin (besides standard anti-bacterial prophylaxis) and samples for a pharmacokinetic curve will be taken. These PK-values can then be compared to the PK in a normal-weight group which will receive 100mg micafungin
Detailed description
Obese patients with a BMI ≥ 40 kg/m2 undergoing endoscopic gastric bypass surgery will receive a 100 mg or a 200mg dose of micafungin. A PK curve will be determined after administration at t=0.5, 0.95, 1.25, 1.5, 2, 4, 8, 12, 24, and (if feasible) 48 hours post infusion. Blood samples (4 mL) on PK days will be taken to obtain at least 2.0 mL of plasma.
Interventions
DRUGMicafungin
Administration of study drug
Sponsors
St. Antonius Hospital
Astellas Pharma Inc
Radboud University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects BMI: * obese groups: subject must have a BMI \> 40 kg/m2 at the time of inclusion, * 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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Micafungin concentration in plasma to examen the area under the plasma concentration versus time curve (AUC0-48) | Up to 3 months | The exposure to micafungin in obese will be compared with that in non-obese subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term exposure to micafungin after repeated dose | Up to 6 months | Predict long-term exposure (AUC0-tau) after repeated dosing by popPK modeling and simulation. |
Countries
Netherlands
Outcome results
None listed