Overview

Abelcet Radiotagging Protocol: Inhaled Lipid Complex AbelcetĀ® in Lung Transplant Recipients

Status:
Terminated
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to quantify the dose of aerosol medication deposited in the lungs of lung transplant recipients receiving a single nebulized treatment of aerosolized AbelcetĀ® (lipid complexed amphotericin-B). This study is being performed to determine the range of deposited doses and patterns of distribution that could be expected in this population so that the ultimate efficacy of this preparation can be evaluated. A radioisotope technique will be utilized to track the medication dose. The study will include 12 subjects who will perform one testing session lasting approximately 3 hours. An Investigational New Drug Application (IND) detailing this protocol has been submitted by the principal investigator (PI) and approved by the Food and Drug Administration [FDA] (72,521).
Phase:
Phase 3
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
Enzon Pharmaceuticals, Inc.
Treatments:
Amphotericin B
Liposomal amphotericin B