Morbid ObesityPhase 4MICADONCT03102658
Micafungin Pharmacokinetics in Obese Patients
A Phase 4 study testing Micafungin in people with Morbid Obesity, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Micafungin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jan 2017to Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- For the non-obese subjects the following additional exclusion criteria apply:
- 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.
Who cannot join
- 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.
- For the non-obese subjects the following additional exclusion criteria apply:
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs or clinical laboratory determinations;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
St Antoniusziekenhuis
Nieuwegein
Radboudumc CRCN
Nijmegen
About this study
Official title: Micafungin (Mycamine®) Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (MICADO).
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
Read the 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.
- Conditions
- Morbid Obesity
- Being tested
- Micafungin
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called Mycamine
Administration of study drug
| Study group | Role | What they receive |
|---|---|---|
| Obese subjects 100mg | Experimental | 8 subjects with a BMI>40kg/m2 will receive 100mg Micafungin Receives: Drug: Micafungin |
| Obese subjects 200mg | Active comparator | 8 subjects with a BMI>40kg/m2 will receive 200mg Micafungin Receives: Drug: Micafungin |
| non-obese subjects | Active comparator | 8 non obese subjects with a BMI >18.5 and <25 kg/m2 will receive 100mg Micafungin Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (1)
Long-term exposure to micafungin after repeated dose
Predict long-term exposure (AUC0-tau) after repeated dosing by popPK modeling and simulation.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startJan 2017
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital, Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Roger Brüggemann, PharmD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102658
- Sponsor's protocol ID
- UMCN-AKF 16.02
- Acronym
- MICADO
- Status last verified
- Sep 2017
- First submitted
- 5 Jan 2017
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30649375
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micafungin (Mycamine®) Pharmacokinetics Given as a Single Intravenous Dose to Obese Patients (MICADO).
- ClinicalTrials.gov ID
- NCT03102658
- Acronym / sponsor ID
- MICADO / UMCN-AKF 16.02
- Conditions
- Morbid Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- St. Antonius Hospital, Astellas Pharma Inc
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese subjects 100mg | Experimental | Drug: Micafungin8 subjects with a BMI>40kg/m2 will receive 100mg Micafungin |
| Obese subjects 200mg | Active comparator | Drug: Micafungin8 subjects with a BMI>40kg/m2 will receive 200mg Micafungin |
| non-obese subjects | Active comparator | Drug: Micafungin8 non obese subjects with a BMI >18.5 and <25 kg/m2 will receive 100mg Micafungin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicafunginAlso: MycamineAdministration of study drug | Drug | Obese subjects 100mg, Obese subjects 200mg, non-obese subjects |
Primary outcome
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.
1 secondary outcome
Long-term exposure to micafungin after repeated dose
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Results publication: PubMed 30649375Wasmann 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.
- paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Brüggemann, PharmD, PhD principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Micafungin in people with Morbid Obesity, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Micafungin concentration in plasma to examen the area under the plasma concentration versus time curve (AUC0-48) (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.