Pharmacokinetics, Pharmacodynamics, and Safety of ET-26 in Subjects with Mild to Moderate Renal Impairment.

ABSTRACT:

Background and objectives

ET-26 is a novel etomidate analog with reduced adrenal suppression. This study evaluated its pharmacokinetics (PK), pharmacodynamics (PD), and safety in subjects with mild to moderate renal impairment.

Methods

In this phase I trial, 24 subjects (normal renal function, mild renal impairment, moderate renal impairment; n = 8/group) received a single intravenous bolus ET-26 dose. PK parameters (C_max, AUC_0-∞, CL), urinary excretion, PD (time to unconsciousness, area under the curve [AUC] of the Bispectral Index [BIS]), and safety were assessed.

Results

Systemic exposure (AUC_0-∞) differed by < 16% between renal impairment and normal groups (geometric mean ratios: 84.70-86.85%). C_max was ~ 46% lower in re

SUBMITTER: Yang F 

PROVIDER: S-EPMC12756201 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature