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Trial record 70 of 730 for:    Area Under Curve AND Bioavailability

Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration (FOLIA)

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ClinicalTrials.gov Identifier: NCT04122560
Recruitment Status : Not yet recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
St. Antonius Hospital
Information provided by (Responsible Party):
Radboud University

Brief 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 design.

A full pharmacokinetic curve will be obtained until 48 hours after intravenous administration.


Condition or disease Intervention/treatment Phase
Fluconazole Candidiasis Invasive Fungal Infections Obesity Drug: Fluconazole 200mg tab Drug: Fluconazole 2 MG/ML Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparing a 2 groups of obese subjects vs 1 group of non-obese subjects
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration (FOLIA)
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Fluconazole

Arm Intervention/treatment
Experimental: Obese subjects

Drug: Fluconazole tablet (diflucan) 200mg Single dose by oral administration of 400mg

Drug: Fluconazole injection (diflucan) 400mg Single dose by intravenous infusion 400mg

Drug: Fluconazole 200mg tab
PO dose of 400mg
Other Name: Diflucan

Drug: Fluconazole 2 MG/ML
IV dose of 400mg
Other Name: Diflucan

Active Comparator: Non-obese subjects

Drug: Fluconazole tablet (diflucan) 200mg Single dose by oral administration of 400mg

Drug: Fluconazole injection (diflucan) 400mg Single dose by intravenous infusion 400mg

Drug: Fluconazole 200mg tab
PO dose of 400mg
Other Name: Diflucan

Drug: Fluconazole 2 MG/ML
IV dose of 400mg
Other Name: Diflucan




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of fluconazole augmented dose [ 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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects BMI:

    1. obese groups: subject must have a BMI ≥35 kg/m2 at the time of inclusion or has undergone bariatric surgery;
    2. non-obese group: subject must have a BMI ≥18.5 and <30 kg/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. Subject able and willing to sign the Informed Consent before screening evaluations.
  4. 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:

  5. 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.

Exclusion Criteria:

  1. Documented history of sensitivity to fluconazole or similar azole-compound;
  2. Documented history of the long QT syndrome (LQTS);
  3. History of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration);
  4. 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;
  5. 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;
  6. Blood transfusion within 8 weeks prior to study drug administration;
  7. Treatment with the concerning study drug up to 7 days before administration of the study drug;
  8. Any other sound medical, psychiatric and/or social reason as determined by the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122560


Locations
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Netherlands
St. Antonius hospital
Nieuwegein, Netherlands
Radboudumc Not yet recruiting
Nijmegen, Netherlands
Contact: Angela Colbers, PhD    0243616405      
Sponsors and Collaborators
Radboud University
St. Antonius Hospital

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04122560     History of Changes
Other Study ID Numbers: UMCN-AKF-18.07
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Radboud University:
fluconazole
candidiasis
invasive fungal infections
mycoses
antifungal agents
Additional relevant MeSH terms:
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Candidiasis
Mycoses
Invasive Fungal Infections
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors