Healthy Volunteers Clinical Trial
Official title:
A Phase 1 Open Label, 2 Part, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole
This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in healthy subjects with normal renal function.
In Part 1, eligible subjects will be enrolled into one of 2 groups based on their renal
function. All subjects will receive a single 1-hour infusion of isavuconazole and will
remain confined for 4 days. Subjects with normal renal function will return to the clinic
for several outpatient visits over 15 days after dosing. Subjects with renal disease will
complete the same outpatient visits which correspond to scheduled dialysis dates and then be
readmitted to the clinic on study Day 15 to receive a second 1-hour infusion of
isavuconazole followed by their normal dialysis procedure and then remain confined for 4
days. ECGs, vital signs, blood draws will be obtained throughout the study for safety and to
assess the amount of study drug in the body as well as study drug removed in subjects
undergoing dialysis.
In Part 2, eligible subjects will be enrolled into one of 4 groups based on their renal
function. All subjects will receive a single 1-hour infusion of isavuconazole and remain
confined for 4 days. Subjects will return to the clinic for several outpatient visits over
15 days after dosing. ECGs, vital signs, blood draws will be obtained throughout the study
for safety and to assess the amount of study drug in the body.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
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