Pharmacokinetics of the addition of an acidic beverage to posaconazole co-administered with a proton pump inhibitor in GVHD patients

Phase 4

Completed

Conditions: graft versus host ziekte
10017528

Registration Number: NL-OMON36495

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

*recipients of hematopoietic stem-cell transplantation (HSCT) with graft versus host disease (GVHD) using PPI
*start or use of posaconazole for invasive fungal infection (IFI) prophylaxis with concomitant PPI use for at least twelve days or one week when already using posaconazole

Exclusion Criteria

*current clinical significant invasive fungal infection requiring treatment
*inability to sign informed consent
*inability to take oral medication
*allergy to posaconazole, PPI or the acidic beverage
*start or discontinuation of a CYP3a4 inhibitor or P-glycoprotein inducer during the study period
*age < 18 years
*grade II or more diarrhea, mucositis, vomiting

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>difference in the bioavailability of posaconazole within patients on PPI with<br /><br>or without concomitant use of the acidic beverage in hematopoietic stem-cell<br /><br>transplantation patients with graft versus host disease.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate whether the plasma concentrations of posaconazole in<br /><br>graft-versus-host-disease (GVHD) patients, adversely affected by the<br /><br>co-administration of proton pump inhibitors (PPIs), can be restored by the<br /><br>acidic beverage.<br /><br>Feasibility of concomitant administration of posaconazole and the acidic<br /><br>beverage in GVHD patients. Plasma pharmacokinetics of posaconazole at the start<br /><br>and at steady-state in graft-versus-host-disease (GVHD) patients concomitantly<br /><br>using PPI.</p><br>