Plazomicin Pharmacokinetics in Indian Complicated Urinary Tract Infections Patients: A Subgroup Analysis from a Phase 2 Study.

Multidrug-resistant Enterobacteriaceae are a primary cause of complicated urinary tract infections (cUTIs) worldwide. This study compared pharmacokinetic (PK) parameters of plazomicin among Indian versus non-India participants. This was a post hoc analysis of PK data from the Phase 2 study (ACHN-490-002), a multicenter, double-blind, randomized, comparator-controlled study. Eligible participants (aged 18-85 years, body weight ≤100 kg) with documented/suspected cUTI or acute pyelonephritis received either 10 or 15 mg/kg plazomicin. Among 91 participants, 70 were non-Indian and 21 were Indian. For the 15 mg/kg dose, plazomicin demonstrated a higher area under the plasma time-concentration curve from time 0 to 24 h (AUC0-24) and maximum concentration (Cmax) compared to the 10 mg/kg dose, which showed greater variability. At the 10 mg/kg dose, Indian participants had a mean AUC0-24 of 163.0 mg•h/L, while non-Indian participants had a mean AUC0-24 of 185.0 mg•h/L. The estimated mean plazomicin AUC0-24 values were comparable between Indian and non-Indian participants. The mean Cmax for Indian participants was 17.2 mg•h/L, and for non-Indian participants it was 15.7 mg•h/L. Dose-normalized AUC0-24 and Cmax point estimates were 110% and 103%, respectively. This showed comparable plazomicin exposure in Indian and non-Indian patients.