A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients (NCT03241550) | Clinical Trial Compass
CompletedPhase 1
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
United States49 participantsStarted 2017-10-02
Plain-language 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.
Who can participate
Age range1 Year – 17 Years
SexALL
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Inclusion Criteria:
* 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 admi…
What they're measuring
1
Pharmacokinetics (PK) of isavuconazole in plasma: Cmax at steady state