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

• Status: Terminated
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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 Abelcet® (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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: Enzon Pharmaceuticals, Inc.
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

1. Single or double lung transplant recipients

2. Age > 18

3. Willing to be available at the testing center

4. Able to understand and complete informed consent

Exclusion Criteria:

1. Pregnant women, or women capable of bearing children who will not perform urine pregnancy test.

2. Nursing mothers.

3. Hypersensitivity to amphotericin B (Abelcet®) or technetium [Tc-99m] based radiopharmaceuticals.

4. Subjects with a past history of bronchospasm associated with aerosol drug use

5. Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications

6. Subjects with an FEV1 < 30% predicted or forced vital capacity (FVC) % predicted < 30%

7. Subjects requiring supplemental oxygen

8. Receipt of inhalational or IV amphotericin B within last 30 days

9. Subjects with known fungal infection, as per Mycoses Study Group (MSG) criteria, on therapy with antifungal drugs or diagnosed on the day of bronchoscopy

10. Serum creatinine > 1.9 mg/dl on the day of clinic visit

11. Liver enzymes ALT/AST/alk phos greater than two times the normal limit

12. Concurrent intravenous aminoglycoside use

13. Subjects with fever > 38.2°C

14. Subjects on mechanical ventilation.

15. Have participated in any studies involving radiopharmaceuticals within 14 days.