NCT04122560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

October 3, 2019

Last Update Submit

July 13, 2021

Conditions

FluconazoleCandidiasisInvasive Fungal InfectionsObesity

Keywords

fluconazolecandidiasisinvasive fungal infectionsmycosesantifungal agents

Outcome Measures

Primary Outcomes (1)

  • 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)

    48 hours

Secondary Outcomes (1)

  • Area under the plasma concentration versus time curve (AUC) of fluconazole augmented dose

    48 hours

Study Arms (2)

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

Drug: Fluconazole 200mg tabDrug: 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

Drug: Fluconazole 200mg tabDrug: Fluconazole 2 MG/ML

Interventions

Fluconazole 200mg tabDRUG

PO dose of 400mg

Also known as: Diflucan
Non-obese subjectsObese subjects
Fluconazole 2 MG/MLDRUG

IV dose of 400mg

Also known as: Diflucan
Non-obese subjectsObese subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Antonius hospital

Nieuwegein, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

CandidiasisInvasive Fungal InfectionsObesityMycoses

Interventions

Fluconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparing a 2 groups of obese subjects vs 1 group of non-obese subjects
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 10, 2019

Study Start

November 30, 2019

Primary Completion

March 23, 2021

Study Completion

March 23, 2021

Last Updated

July 14, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)