FluconazolePhase 4FOLIANCT04122560
Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration
A Phase 4 study testing Fluconazole 200mg tab and Fluconazole 2 MG/ML in people with Fluconazole and Candidiasis, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
The pharmacokinetics of fluconazole are expected to be different in obese patients compared to non-obese patients. The investigators will determine fluconazole and free fluconazole concentrations in 16 obese patients and 8 healthy volunteers, who will receive oral and intravenous fluconazole in a semi-simultaneous… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fluconazole, Candidiasis, Invasive Fungal Infections
- What is being tested?
- Fluconazole 200mg tab and Fluconazole 2 MG/ML
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesNetherlands
- Study dates
- 30 Nov 2019to 23 Mar 2021
- 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 ≥35 kg/m2 at the time of inclusion or has undergone bariatric surgery;
- non-obese group: subject must have a BMI ≥18.5 and <30 kg/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;
- Subject able and willing to sign the Informed Consent before screening evaluations.
- If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
- For the non-obese subjects the following additional inclusion criteria applies:
- Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry and hematology within 6 weeks prior to study drug administration. Results of biochemistry and hematology should be within the laboratory's reference ranges (see Appendix A). 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.
Who cannot join
- Documented history of sensitivity to fluconazole or similar azole-compound;
- Documented history of the long QT syndrome (LQTS);
- History of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration);
- Use of medication that has known relevant interaction with study drug as determined by the investigator up to 1 weeks prior to study drug administration;
- 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;
- Treatment with the concerning study drug up to 7 days before administration of the study drug;
- Any other sound medical, psychiatric and/or social reason as determined by the investigator.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration (FOLIA)
The pharmacokinetics of fluconazole are expected to be different in obese patients compared to non-obese patients. The investigators will determine fluconazole and free fluconazole concentrations in 16 obese patients and 8 healthy volunteers, who will receive oral and intravenous fluconazole in a semi-simultaneous design.
A full pharmacokinetic curve will be obtained until 48 hours after intravenous administration.
Read the detailed description
The pharmacokinetics of fluconazole are expected to be different in obese patients compared to non-obese patients. Therefore, extrapolation of data from healthy volunteers and is not possible.
To investigate these differences 16 obese patients and 8 healthy subjects will be studied.
Patients will receive fluconazole by semi-simultaneous design. Blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter. A maximum of 100 milliliter blood in total will be drawn for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug.
Full pharmacokinetic curves will be taken after oral and intravenous administration. This pharmacokinetic analysis will enable the determination of bioavailability and enable the determination of intra-individual variability.
- Conditions
- Fluconazole, Candidiasis, Invasive Fungal Infections, Obesity
- Being tested
- Fluconazole 200mg tab, Fluconazole 2 MG/ML
- Keywords
- fluconazole, candidiasis, invasive fungal infections, mycoses, antifungal agents
- Medical subject headings
- Candidiasis, Invasive Fungal Infections, Obesity, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluconazole 200mg tabDrug
Also called Diflucan
PO dose of 400mg
Fluconazole 2 MG/MLDrug
Also called Diflucan
IV dose of 400mg
| Study group | Role | What they receive |
|---|---|---|
| Obese subjects | Experimental | Drug: Fluconazole tablet (diflucan) 200mg Single dose by oral administration of 400mg
Drug: Fluconazole injection (diflucan) 400mg Single dose by intravenous infusion 400mg Receives: Drug: Fluconazole 200mg tab; Drug: Fluconazole 2 MG/ML |
| Non-obese subjects | Active comparator | Drug: Fluconazole tablet (diflucan) 200mg Single dose by oral administration of 400mg
Drug: Fluconazole injection (diflucan) 400mg Single dose by intravenous infusion 400mg Receives: Drug: Fluconazole 200mg tab; Drug: Fluconazole 2 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of fluconazole
The concentration-time curve of fluconazole will be compared with that in non-obese subjects. Exposure is assessed by area-under-the-curve from zero to 48 hours (AUC0-48h)
Measured: 48 hours
Secondary outcomes (1)
Area under the plasma concentration versus time curve (AUC) of fluconazole augmented dose
The concentration-time curve of fluconazole will be compared with that in non-obese subjects. Exposure is assessed by area-under-the-curve from zero to 48 hours (AUC0-48h)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start30 Nov 2019
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FluconazoleStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparing a 2 groups of obese subjects vs 1 group of non-obese subjects
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122560
- Sponsor's protocol ID
- UMCN-AKF-18.07
- Acronym
- FOLIA
- Status last verified
- Jul 2021
- First submitted
- 3 Oct 2019
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration (FOLIA)
- ClinicalTrials.gov ID
- NCT04122560
- Acronym / sponsor ID
- FOLIA / UMCN-AKF-18.07
- Conditions
- Fluconazole, Candidiasis, Invasive Fungal Infections, Obesity
- Keywords
- fluconazole, candidiasis, invasive fungal infections, mycoses, antifungal agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- St. Antonius Hospital
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 10 Oct 2019 (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.
The pharmacokinetics of fluconazole are expected to be different in obese patients compared to non-obese patients. The investigators will determine fluconazole and free fluconazole concentrations in 16 obese patients and 8 healthy volunteers, who will receive oral and intravenous fluconazole in a semi-simultaneous design.
A full pharmacokinetic curve will be obtained until 48 hours after intravenous administration.
Detailed description
The pharmacokinetics of fluconazole are expected to be different in obese patients compared to non-obese patients. Therefore, extrapolation of data from healthy volunteers and is not possible.
To investigate these differences 16 obese patients and 8 healthy subjects will be studied.
Patients will receive fluconazole by semi-simultaneous design. Blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter. A maximum of 100 milliliter blood in total will be drawn for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug.
Full pharmacokinetic curves will be taken after oral and intravenous administration. This pharmacokinetic analysis will enable the determination of bioavailability and enable the determination of intra-individual variability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparing a 2 groups of obese subjects vs 1 group of non-obese subjects
| Arm | Type | Receives |
|---|---|---|
| Obese subjects | Experimental | Drug: Fluconazole 200mg tab, Drug: Fluconazole 2 MG/MLDrug: Fluconazole tablet (diflucan) 200mg Single dose by oral administration of 400mg Drug: Fluconazole injection (diflucan) 400mg Single dose by intravenous infusion 400mg |
| Non-obese subjects | Active comparator | Drug: Fluconazole 200mg tab, Drug: Fluconazole 2 MG/MLDrug: Fluconazole tablet (diflucan) 200mg Single dose by oral administration of 400mg Drug: Fluconazole injection (diflucan) 400mg Single dose by intravenous infusion 400mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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;
- Subject able and willing to sign the Informed Consent before screening evaluations.
- If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
- Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry and hematology within 6 weeks prior to study drug administration. Results of biochemistry and hematology should be within the laboratory's reference ranges (see Appendix A). 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 (8 listed)
- Documented history of sensitivity to fluconazole or similar azole-compound;
- Documented history of the long QT syndrome (LQTS);
- History of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration);
- Use of medication that has known relevant interaction with study drug as determined by the investigator up to 1 weeks prior to study drug administration;
- 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;
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 |
|---|---|---|
| Fluconazole 200mg tabAlso: DiflucanPO dose of 400mg | Drug | Non-obese subjects, Obese subjects |
| Fluconazole 2 MG/MLAlso: DiflucanIV dose of 400mg | Drug | Non-obese subjects, Obese subjects |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of fluconazole
Time frame: 48 hours
The concentration-time curve of fluconazole will be compared with that in non-obese subjects. Exposure is assessed by area-under-the-curve from zero to 48 hours (AUC0-48h)
1 secondary outcome
Area under the plasma concentration versus time curve (AUC) of fluconazole augmented dose
Time frame: 48 hours
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 14 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fluconazole 200mg tab and Fluconazole 2 MG/ML in people with Fluconazole and Candidiasis, 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 8 inclusion and 8 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 14 Jul 2021. 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?
Area under the plasma concentration versus time curve (AUC) of fluconazole (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2021.