Plazomicin Pharmacokinetics in Indian Complicated Urinary Tract Infections Patients: A Subgroup Analysis From 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 (AUC 0‐24 ) and maximum concentration (C max ) compared to the 10 mg/kg dose, which showed greater variability. At the 10 mg/kg dose, Indian participants had a mean AUC 0‐24 of 163.0 mg•h/L, while non–Indian participants had a mean AUC 0‐24 of 185.0 mg•h/L. The estimated mean plazomicin AUC 0‐24 values were comparable between Indian and non–Indian participants. The mean C max for Indian participants was 17.2 mg•h/L, and for non–Indian participants it was 15.7 mg•h/L. Dose–normalized AUC 0‐24 and C max point estimates were 110% and 103%, respectively. This showed comparable plazomicin exposure in Indian and non–Indian patients.