Pharmacokinetics of posaconazole given as a single intravenous dose to obese subjects: Dosing Obese with Noxafil® Under a Trial (DONUT).

Phase 4

Completed

• Conditions: Fungal infection / aspergillose; 10017528

• Registration Number: NL-OMON45475
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-09-01
• Results First Posted: 2019-12-06
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

1. Subjects BMI:
o obese groups: subject must have a BMI >=35 kg/m2 at the time of inclusion,
o non-obese group: subject must have a BMI >=18.5 and < 25kg/m2 at the time of inclusion.;2. Subject is at least 18 years of age on the day of screening and not older than 65 years of age on the day of dosing;
3. If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant;;4. Subject is able and willing to sign the Informed Consent before screening evaluations.
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, hematology and urinalysis testing within 6 weeks prior to study drug administration. Results of biochemistry, hematology and urinalysis testing 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 medicinal products or excipients similar to those found in the posaconazole 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. Any other sound medical, psychiatric and/or social reason as determined by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A farmacokinetic model using Non Linear Mixed Effects Modelling (NONMEM). Model<br /><br>validation using bootstrap<br /><br>method. The final model will be used for Monte Carlo simulation for<br /><br>multiple-dosing regimens and higher dosages.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>