A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

Completed · Phase 1

Conditions studied: Hematological Malignancy

In brief

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.

Key facts

Study ID: NCT03241550
Run by: Astellas Pharma Global Development, Inc.
People needed: 49
Starts: 2017-10-02
Expected to finish: 2019-07-05
Last updated by the study team: 2024-11-19

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has sufficient venous access to permit administration of study drug (for the IV cohorts), collection of pharmacokinetic samples and monitoring of safety laboratories.
Female subject must either:
Be of non-childbearing potential: Clearly premenarchal or documented surgically sterile
Or, if of childbearing potential: Agree not to try to become pregnant during the study and for 28 days after the final study drug administration; and have a negative urine or serum pregnancy test at screening; and, if heterosexually active, agree to consistently use 2 forms of highly effective birth control (at least one of which must be a barrier method) starting at screening and throughout the study and for 28 days after the final study drug administration.
Female subject who is of childbearing potential must agree not to breastfeed starting at screening and throughout the study and for 28 days after the final study drug administration.
Female subject who is of childbearing potential must not donate ova starting at screening and throughout the study and for 28 days after the final study drug administration.
Male subject who is of childbearing potential and their female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (at least one of which must be a barrier method) starting at screening and continue throughout the study, and for 90 days after the final study drug administration.
Male subject who is of childbearing potential must not donate sperm starting at screening and throughout the study and, for 90 days after the final study drug administration.
Subject and subject's parent(s) or legal guardian agree that the subject will not participate in another interventional study while on treatment.
For oral cohorts: subject is able to swallow the oral capsule medication.

You may not qualify if…

Subject has familial short QT syndrome, is receiving medications that are known to shorten the QT interval, or has a clinically significant abnormal electrocardiogram (ECG).
Subject has evidence of hepatic dysfunction defined as:
Total bilirubin ≥ 3 times the upper limit of normal (ULN)
Alanine transaminase or aspartate transaminase ≥ 5 times the ULN
Known cirrhosis or chronic hepatic failure
Subject has used strong cytochrome P450 (CYP) 3A4 inhibitors or inducers such as ketoconazole, rifampin/rifampicin, long acting barbiturates, carbamazepine and St. John's wort in the 5 days prior to the first administration of study drug.
Subject has known history of allergy, hypersensitivity, or any serious reaction to any of the azole class antifungals.
Subject has any condition which makes the subject unsuitable for study participation.
Subject is unlikely to survive 30 days.
Subject has received investigational therapy, with the exception of oncology drug trials, within 28 days or 5 half-lives, whichever is longer, prior to screening.
For oral cohorts: The subject has gastrointestinal disease or has had a procedure that is expected to interfere with the oral absorption or tolerance of the study drug (e.g., functionally relevant gastrointestinal obstruction, mucositis/stomatitis, or frequent vomiting).
Subject previously dosed with isavuconazonium sulfate.

Where it is running

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

Full record on ClinicalTrials.gov

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