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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
49
IV
DaVita Research
Denver, Colorado, United States
Clinical Pharmacology Miami
Miami, Florida, United States
DaVita Clinical Research
Minneapolis, Minnesota, United States
Pharmacokinetics variables for BAL4815 (in plasma): AUC72 and Cmax
Area under the concentration-time curve from 0 to 72 hours (AUC72) and Maximum concentration (Cmax)
Time frame: Day 1, Part 1
Pharmacokinetics variables for BAL4815 (in plasma): AUCinf, AUClast, and Cmax
Area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf), Area under the plasma concentration-time curve from time of dosing to the last quantifiable concentration (AUClast)
Time frame: Day 1, Part 2
Pharmacokinetics variables for BAL4815 (in plasma): AUCinf and AUClast
Time frame: Day 1, Part 1
Pharmacokinetics variables for BAL4815 (in plasma): tmax, t1/2, Vz, and CLtot , Ae, Ae% , CLR
Time to attain maximum concentration (tmax), Apparent terminal elimination half-life (t ½), Apparent volume of distribution during terminal phase (Vz), Total clearance (CLtot), Cumulative amount of unchanged drug excreted in urine (Ae), Percent of drug excreted in urine (Ae%), Renal clearance of the drug from plasma (CLR)
Time frame: Day 1, Parts 1 and 2
Pharmacokinetics unbound (u) variables for BAL4815 (in plasma and in urine): AUC inf,u, AUC72,u, AUClast,u, Cmax,u, Vz,u, CLtot,u, CLR,u
Time frame: Day 1, Parts 1 and 2
Pharmacokinetics variables for End Stage Renal Disease (ESRD) subjects for BAL4815: AUC72, Cmax, and tmax
Time frame: Day 15, Part 1
Pharmacokinetics variables for BAL8728 (in plasma and urine): AUCinf, AUClast, AUC72, Cmax, tmax , t1/2, Vz, CLtot, Ae, Ae% , CLR
Time frame: Day 1, Parts 1 and 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacokinetics variables for End Stage Renal Disease (ESRD) subjects for BAL8728: AUC72, Cmax, and tmax
Time frame: Day 15, Part 1
Safety assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs)
Time frame: Part 1: Continuous, up to Day 24; Part 2: Continuous, up to Day 15