Micafungin Pharmacokinetics in Obese Patients

Phase 4

Completed

• Conditions: Morbid Obesity
• Interventions: Drug: Micafungin

• Registration Number: NCT03102658
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-06
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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, alanine aminotransferase, aspartate transaminase) 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese subjects 100mg	Micafungin	8 subjects with a BMI\>40kg/m2 will receive 100mg Micafungin
non-obese subjects	Micafungin	8 non obese subjects with a BMI \>18.5 and \<25 kg/m2 will receive 100mg Micafungin
Obese subjects 200mg	Micafungin	8 subjects with a BMI\>40kg/m2 will receive 200mg Micafungin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

St Antoniusziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Radboudumc CRCN; 🇳🇱 Nijmegen, Netherlands