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Micafungin Pharmacokinetics in Obese Patients (MICADO)

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ClinicalTrials.gov Identifier: NCT03102658
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
St. Antonius Hospital
Astellas Pharma Inc
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE January 5, 2017
First Posted Date  ICMJE April 6, 2017
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
Micafungin concentration in plasma to examen the area under the plasma concentration versus time curve (AUC0-48) [ Time Frame: Up to 3 months ]
The exposure to micafungin in obese will be compared with that in non-obese subjects.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
Long-term exposure to micafungin after repeated dose [ Time Frame: Up to 6 months ]
Predict long-term exposure (AUC0-tau) after repeated dosing by popPK modeling and simulation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Micafungin Pharmacokinetics in Obese Patients
Official Title  ICMJE Micafungin (Mycamine®) Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (MICADO).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Morbid Obesity
Intervention  ICMJE Drug: Micafungin
Administration of study drug
Other Name: Mycamine
Study Arms  ICMJE
  • Experimental: Obese subjects 100mg
    8 subjects with a BMI>40kg/m2 will receive 100mg Micafungin
    Intervention: Drug: Micafungin
  • Active Comparator: Obese subjects 200mg
    8 subjects with a BMI>40kg/m2 will receive 200mg Micafungin
    Intervention: Drug: Micafungin
  • Active Comparator: non-obese subjects
    8 non obese subjects with a BMI >18.5 and <25 kg/m2 will receive 100mg Micafungin
    Intervention: Drug: Micafungin
Publications * Wasmann RE, Smit C, Ter Heine R, Koele SE, van Dongen EPH, Wiezer RMJ, Burger DM, Knibbe CAJ, Brüggemann RJM. Pharmacokinetics and probability of target attainment for micafungin in normal-weight and morbidly obese adults. J Antimicrob Chemother. 2019 Apr 1;74(4):978-985. doi: 10.1093/jac/dky554.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2017)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03102658
Other Study ID Numbers  ICMJE UMCN-AKF 16.02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE
  • St. Antonius Hospital
  • Astellas Pharma Inc
Investigators  ICMJE
Principal Investigator: Roger Brüggemann, PharmD, PhD Radboud University
PRS Account Radboud University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP