Comparative study of the pharmacokinetics, efficacy and safety of ET-26 in
elderly and non-elderly subjects: the results of a phase I clinical trial
#MMPMID41181598
Yang F
; Sun J
; Ye PP
; Lv WS
; Li LZ
; Zhao BZ
; Van Den Anker J
; Zheng Y
; Ke BW
; Yang XR
; Zhao W
Front Pharmacol
2025[]; 16
(?): 1665322
PMID41181598
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AIM: To evaluate the pharmacokinetics, pharmacodynamics, and safety of the novel
systemic intravenous anesthetic ET-26-an etomidate derivative designed to reduce
adrenal suppression-in healthy elderly and non-elderly subjects. METHODS: In this
Phase I, single-center, non-randomized, open-label trial, 16 volunteers were
enrolled: eight elderly (?65 years, including ?75 years) and eight non-elderly
(18-64 years), matched for gender and body weight. Each received a standardized
IV infusion of ET-26. Plasma concentrations were measured for plasma protein
binding, C(max,) and AUC; time to loss of consciousness (LOC) and safety were
assessed. RESULTS: In 16 subjects (8 elderly/8 non-elderly), ET-26 showed higher
exposure in the elderly (C(max) GMR 198.81%, 90% CI 126.51-312.45) and AUC0-? was
23.5% higher (90% CI: 107.6%-141.9%) with comparable pharmacodynamics (median LOC
time 1.933 min). Plasma protein binding remained stable (intergroup difference
?1.0%). Drug-related TEAEs (37.5%) were mild and self-limiting. CONCLUSION:
Despite elevated systemic exposure in elderly subjects, ET-26 demonstrates
comparable efficacy and retains a favorable tolerability profile across age
groups, eliminating the need for dose adjustments in elderly populations.
CLINICAL TRIAL REGISTRATION:
http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml?keywords=CTR20233784,
identifier CTR20233784.
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