Pharmacokinetics of Posaconazole (Noxafil®) as Prophylaxis for Invasive Fungal Infections — PIRAÑA  

Acute Graft Versus Host Disease Clinical Trial

Official title: Pharmacokinetics of Posaconazole (Noxafil®) as Prophylaxis for Invasive Fungal Infections

Status Completed

Clinical Trial Summary

This study evaluates the the pharmacokinetics of posaconazole (new solid oral and IV) given as prophylaxis to patients who are at risk for developing fungal infections after receiving conditioning therapy (except strictly non-myeloablative (NMA)) for allogeneic Stem Cell Transplant (SCT), remission induction chemotherapy for acute myeloid leukemia (AML) or myelo dysplastic syndrome (MDS) or being treated for severe graft versus host disease (GvHD) and determines the impact of mucositis on the pharmacokinetics of posaconazole new solid oral.

Clinical Trial Description

In 2014, the new intravenous and solid oral formulation of posaconazole were marketed. This offers new treatment possibilities, specifically in patients previously unable to attain adequate exposure to posaconazole solution. To the opinion of the researchers, only limited data are available on the pharmacokinetics (PK) of the new formulations of posaconazole, however, these use strictly selected patients or healthy volunteers, but more importantly, specific aspects related to the PK remain unsolved. Despite the fact that adequate exposure is attained using the new solid oral formulation, it is hypothesized that oral bioavailability of posaconazole may be impacted during mucositis. Whether mucosal barrier injury impacts the absorption of posaconazole or alters presystemic clearance is still unknown. Therefore, it seems prudent to conduct a trial in a group of patients that will experience a severe degree of mucositis to identify changes in absorption of posaconazole and resolving the impact of various stages of mucositis on the PK of posaconazole by linking PK of posaconazole to markers of mucositis (citrulline). This research may also serve as a model for other drugs and allows for direct translations in improving patient care. For this purpose it is needed to determine the PK using both IV and PO dosing of posaconazole. ;

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Acute Myeloid Leucaemia
• Allogeneic Stem Cell Transplant
• Graft vs Host Disease
• Invasive Fungal Infections
• Mycoses
• Myelo Dysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

• NCT number: NCT02805946
• Study type: Interventional
• Source: Radboud University
• Status: Completed
• Phase: Phase 4
• Start date: April 28, 2017
• Completion date: September 7, 2019