A Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) and Powder for Oral Suspension Formulations of Posaconazole (POS) in Immunocompromised Pediatric Subjects with Neutropenia (Protocol Number MK-5592)
Sponsor: |
Merck Sharp & Dohme Corp |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAP5251 |
U.S. Govt. ID: |
NCT02452034 |
Contact: |
Jean Sosna, RN: 212-305-2050 / js4403@cumc.columbia.edu |
The purpose of this study is to: 1) Test the safety and tolerability of the research study drug, MK-5592 posaconazole (POS), intravenously (IV) and in powder for oral suspension (PFS), 2) Evaluate the pharmacokinetics (how the study drug is absorbed and broken down in the body), of POS IV solution and POS PFS, and 3) Evaluate the taste and reaction to the taste of the study drug. Do you have documented or anticipated neutropenia expected to last for at least 7 days following the start of treatment for one of the following: Acute leukemia, myelodysplasia, severe aplastic anemia, recipients of autologous HSCT, high risk neuroblastoma, or hemophagocytic lymphohistiocytosis?
This study is closed
Investigator
Monica Bhatia, MD
Are you (or your child) from 2-17 years of age? |
Yes |
No |
Do you have documented or neutropenia expected to last for at least 7 days? |
Yes |
No |