Spots Global Cancer Trial Database for A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
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Trial Identification
Brief Title: A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Official Title: A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
Study ID: NCT03241550
Conditions
Study Description
Brief Summary: The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients. The PK data will be utilized to establish a pediatric population PK model of isavuconazole, the active moiety of isavuconazonium sulfate.
Detailed Description:
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Miller Children's Hospital, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
CHOC Children's Hospital of Orange County, Orange, California, United States
Nicklaus Children's Hospital, Miami, Florida, United States
Emory University School of Medicine, Atlanta, Georgia, United States
Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
University of Louisville, Louisville, Kentucky, United States
Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, United States
Children's Mercy Kansas City, Kansas City, Missouri, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
University Hospital of Cleveland, Cleveland, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
The Children's Hospital at TriStar Centennial Medical Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Texas Children's Hospital, Houston, Texas, United States
Contact Details
Name: Senior Medical Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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