Exposure to fluconazole in obese patients.

Phase 1

• Conditions: Pharmacokinetics of fluconazole in obese subjects.; MedDRA version: 20.0Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-002613-35-NL
• Lead Sponsor: Radboud university medical centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-23
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Subjects BMI:
a.obese groups: subject must have a BMI =35 kg/m2 at the time of inclusion or has undergone bariatric surgery;
b.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.

For the non-obese subjects the following additional inclusion criteria applies:

4.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.
5.If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of obesity (BMI =35 kg/m2) and bariatric surgery on the pharmacokinetics, including oral bioavailability of fluconazole.;Secondary Objective: To develop a dosing regimen for obese patients.;Primary end point(s): Determine PK parameters (Bioavailability, Systemic Clearance, Volume of distribution of<br>central compartment, Volume of distribution of peripheral<br>compartment(s), Intercompartmental Glearance) after a single oral and<br>intravenous dose.;Timepoint(s) of evaluation of this end point: Day 1, 2 and 3

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Simulate PK to predict long-term exposure (after repeated dosing);Timepoint(s) of evaluation of this end point: Day 1, 2 and 3