. Author manuscript; available in PMC: 2016 Jan 1.

Published in final edited form as: Pediatr Blood Cancer. 2014 Sep 9;62(1):65–71. doi: 10.1002/pbc.25133

TABLE II.

Blood plasma pharmacokinetic parameters for cytarabine and daunorubicin following CPX-351 administration in mice (preclinical) versus humans (clinical)

	Cytarabine		Daunorubicin
	Preclinical¹	Clinical²	Preclinical	Clinical
C_max (µg/mL)³	52 ± 16⁴	43 ± 8	24 ± 5	25 ± 5
AUC_0–48 (µg*hr/mL)⁵	322	1158 ± 385	160	553 ± 152
t_{1/2, Z} (hr)⁶	6.2	42.5 ± 26.4	5.9	22.1 ± 6.9

For preclinical pharmacokinetic analyses, female CD-1 mice were administered a single dose of CPX-351 at 5 units/kg;

For the clinical dataset, blood plasma was obtained from Phase I study patients with advanced hematologic malignancies following administration of single-dose CPX-351 at 101 units/m² by i.v. infusion over 90 minutes;

C_max, initial observed peak plasma concentration (preclinical) or observed maximum plasma concentration (clinical). Preclinical C_max based on observed data at 1hr;

⁴

Values are reported as mean ± SD;

⁵

AUC_0–48 based on trapezoidal summation;

⁶

t_{1/2, Z} calculated as ln2/λ where λ is the terminal elimination rate constant estimated from negative slope of log C×T curve between t=6 and t=16 hr time points.