TABLE 3.

Statistical comparison of PK parameters for ESRD subjects dosed after hemodialysis versus healthy subjects^a

PK parameter	Cohortb	Geometric mean	Ratio of geometric mean	90% confidence interval for ratio of geometric mean
AUC0–last (μg · h/ml)	ESRD	9.21	1.03	0.86–1.24
	Healthy	8.91
AUC0–inf (μg · h/ml)	ESRD	10.10	1.05	0.87–1.26
	Healthy	9.61
Cmax (μg/ml)	ESRD	1.78	0.94	0.72–1.23
	Healthy	1.88
CL (liters/h)	ESRD	9.91	0.95	0.79–1.14
	Healthy	10.4

^aThe ANOVA model included log-transformed PK parameters as the response variables and matched pairs as the random effect, and the fixed effect term was ESRD status. AUC_0–last, area under the concentration-time curve from time zero to the last quantifiable concentration in plasma; AUC_0–inf, area under the concentration-time curve from time zero extrapolated to infinity in plasma; C_max, maximum observed concentration of omadacycline in plasma; CL, total body clearance; ESRD, end-stage renal disease; PK, pharmacokinetics.

^bESRD subjects dosed after hemodialysis served as the test cohort for this analysis and healthy subjects served as the reference cohort for this analysis.