Micafungin Pharmacokinetics in Obese Patients

NCT03102658 | Completed Phase 4

• 1 other identifier: UMCN-AKF 16.02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Micafungin concentration in plasma to examen the area under the plasma concentration versus time curve (AUC0-48)

  The exposure to micafungin in obese will be compared with that in non-obese subjects.

  Up to 3 months

Secondary Outcomes (1)

• Long-term exposure to micafungin after repeated dose

  Up to 6 months

Study Arms (3)

Obese subjects 100mg

EXPERIMENTAL

8 subjects with a BMI\>40kg/m2 will receive 100mg Micafungin

Drug: Micafungin

Obese subjects 200mg

ACTIVE COMPARATOR

8 subjects with a BMI\>40kg/m2 will receive 200mg Micafungin

Drug: Micafungin

non-obese subjects

ACTIVE COMPARATOR

8 non obese subjects with a BMI \>18.5 and \<25 kg/m2 will receive 100mg Micafungin

Drug: Micafungin

Interventions

Micafungin DRUG

Administration of study drug

Also known as: Mycamine

Obese subjects 100mg; Obese subjects 200mg; non-obese subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects BMI:
• 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;
• If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant;
• Subject is able and willing to sign the Informed Consent before screening evaluations.

You may not qualify if:

• 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;
• Subject has a normal blood pressure and pulse rate, determined by the investigator;
• 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.
• Documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation;
• History of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration);
• Inability to understand the nature of the trial and the procedures required;
• Use of medication that has known interaction with study drug as determined by the investigator up to 4 weeks prior to study drug administration.
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs or clinical laboratory determinations;
• Clinical relevant liver enzymes (alkaline phosphatase, alanine aminotransferase, aspartate transaminase) abnormalities at screening;
• 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;
• Blood transfusion within 8 weeks prior to study drug administration;
• Inability to be venipunctured and/or tolerate venous access;
• 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;
• Any other sound medical, psychiatric and/or social reason as determined by the investigator.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• St. Antonius Hospital: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (2)

St Antoniusziekenhuis

Nieuwegein, Netherlands

Location

Radboudumc CRCN

Nijmegen, Netherlands

Location

Related Publications (1)

• Wasmann RE, Smit C, Ter Heine R, Koele SE, van Dongen EPH, Wiezer RMJ, Burger DM, Knibbe CAJ, Bruggemann 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.

  PMID: 30649375 RESULT

Related Links

• paper

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Roger Brüggemann, PharmD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: April 6, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 19, 2020

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)