Table 2.

Pharmacokinetics in healthy volunteers from phase I clinical trials of plazomicin.

	Single 7.5 mg/kg dose (30 min infusion)	Single 15 mg/kg dose (30 min infusion)			Single 15 mg/kg dose (10 min infusion)
	P1-01a n = 6	P1-02b n = 16	P1-03c n = 54	P1-04d n = 6	P1-05e n = 6	P1-06f n = 15
AUC0–∞ (mg*h/L)	136 ± 17.2	246 ± 30.8	265 ± 66.5	269 (11.4)	246 ± 39	309 ± 45
Cmax (mg/L)	37.9 ± 5.01	85.2 ± 11.2	76.0 ± 19.6	92.1 (8.4)	144 ± 45	161 ± 31
Vd (L/kg)	0.43 ± 0.09	0.23 ± 0.03	0.24 ± 0.06	0.42 (21.0)	0.20 ± 0.03	0.161 ± 0.0203g
CLT (mL/min per kg)	0.93 ± 0.23	1.03 ± 0.10	0.996 ± 0.195	1.00 (17.1)	1.04 ± 0.17	0.824 ± 0.116
T1/2 (h)	NR	3.82 ± 0.35	3.5 ± 0.5	NR	3.4 ± 0.8	2.8 ± 0.6

Values reported are mean ± SD, except P1-06, which is geometric mean (CV%).

^aP1-01: [ClinicalTrials.gov identifier: NCT01462136], Komirenko et al.²⁷

^bP1-02: [ClinicalTrials.gov identifier: NCT03270553], Choi et al.²⁸

^cP1-03: [ClinicalTrials.gov identifier: NCT01514929], Gall et al.²⁹

^dP1-04: [ClinicalTrials.gov identifier: NCT03177278], Choi et al.³⁰

^eP1-05: [ClinicalTrials.gov identifier: NCT00822978], Cass et al.³¹

^fP1-06: [ClinicalTrials.gov identifier: NCT01034774], Cass et al.³²

^gV_ss = 0.248 L ± 0.0398 L after 5 days of 15 mg/kg.

AUC_0–∞, area under the curve 0–_∞ ; C_max, maximum concentration; CL_T, clearance (total); NR, not reported; T_1/2, half-life; V_d, volume of distribution; V_ss, volume of distribution at steady state