Exposure to posaconazole given intravenous compared to oral.

Phase 1

• Conditions: prophylaxis for patients at high risk for invasive fungal diseases; MedDRA version: 19.1Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-001182-87-BE
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-30
• Study Completion: 2019-02-09
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1.Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
2.Subject is at least 18 years of age on the day of providing informed consent.
3.Patient receives immunosuppressive therapy for acute GVHD, (non)myeloablative or reduced intensity conditioning regimens for SCT, or remission induction chemotherapy for AML/MDS.
4.In case of acute GVHD grade II-IV, patient has received less than 1 week of immunosuppressive therapy.
5.If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
6.Has an ALAT <200U/L, ALAT <225U/L, alkaline phosphatase <60 U/L and a bilirubin level <50 µmol/L.
7.Subject is capable of receiving oral tablets.
8.Subject is managed with a central venous or arterial catheter.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Documented history of sensitivity to medicinal products or excipients similar to those found in the posaconazole preparation.
2.Relevant history or presence of cardiovascular disorders (specific QTc time prolongation).
3.Inability to understand the nature of the trial and the procedures required.
4.Any sign or symptoms of invasive fungal disease or the use of antifungal drugs within the previous month.
5.Has previously participated in this trial.

Study & Design

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