Trial reportFrontiers in pharmacology2026
Pharmacokinetics, safety, and pharmacodynamics of intravenous methoxyethyl etomidate hydrochloride (ET-26-HCl) in Chinese participants with hepatic impairment.
Trial report in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06176716 (Phase I Clinical Study to Evaluate the Pharmacokinetics, Pharmacokinetics, and Safety of Intravenous Administration of Methoxyethyl Etomidate Hydrochloride for Injection in Subjects With Mild, Moderate, and Normal Hepatic Dysfunction.), which is not on this map. Not yet cited in PubMed.
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Phase I Clinical Study to Evaluate the Pharmacokinetics, Pharmacokinetics, and Safety of Intravenous Administration of Methoxyethyl Etomidate Hydrochloride for Injection in Subjects With Mild, Moderate, and Normal Hepatic Dysfunction.
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Authors and funding
7 authors.
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Abstract
Background: Intravenous methoxyethyl etomidate hydrochloride (ET-26-HCl) is a novel etomidate analogue. We aimed to investigate the pharmacokinetics, safety and pharmacodynamics of ET-26-HCl in individuals with hepatic impairment. Methods: In this open-label, parallel study, we compared the pharmacokinetics, pharmacodynamics and safety of a single intravenous bolus dose of 0.8 mg kg Results: Twenty-four participants completed the study. Compared with that of healthy participants, the arterial plasma AUC geometric means of ET-26-HCl were similar in patients with a moderate impairment and increased in those with mild impairment. The geometric mean ratios for the venous plasma AUC of ET-26-HCl were ∼1.31- and ∼1.48-fold greater in patients with mild and moderate impairment, respectively, than in healthy participants. Most AEs were mild to moderate. No serious AEs occurred. The degree of hepatic impairment had little effect on the MOAA/S and BIS of ET-26-HCl. Conclusion: Venous plasma ET-26-HCl exposure was ∼1.31- and ∼1.48-fold greater in patients with mild and moderate hepatic impairment, respectively, than in matched healthy controls. ET-26-HCl was generally safe and well tolerated by all participants in this study. Importantly, these findings should not be extrapolated to patients with severe hepatic impairment. Clinical Trial Registration: NCT06176716, https://clinicaltrials.gov/.
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