Methoxyethyl Etomidate Hydrochloride (ET‐26): A Phase I Clinical Trial Assessing Drug–Drug Interactions in Healthy Subjects
Methoxyethyl etomidate hydrochloride (ET‐26) is a novel intravenous general anesthetic designed to address the clinical limitations of etomidate. This Phase I clinical trial assessed the pharmacokinetics, pharmacodynamics, drug–drug interaction (DDI) potential, and safety of ET‐26 in 68 healthy subj...
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| Published in: | Journal of clinical pharmacology Vol. 65; no. 11; pp. 1443 - 1450 |
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| Main Authors: | , , , , , , , , , , , |
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01.11.2025
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| ISSN: | 0091-2700, 1552-4604, 1552-4604 |
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| Abstract | Methoxyethyl etomidate hydrochloride (ET‐26) is a novel intravenous general anesthetic designed to address the clinical limitations of etomidate. This Phase I clinical trial assessed the pharmacokinetics, pharmacodynamics, drug–drug interaction (DDI) potential, and safety of ET‐26 in 68 healthy subjects across three sequences, evaluating interactions with rifampin (CYP2C19/3A4 inducer), fluconazole (CYP2C19/3A4 inhibitor), and omeprazole/midazolam. ET‐26 pharmacokinetic analyses showed that compared with administration of ET‐26 alone, co‐administration of rifampin resulted in a 10% decrease in the geometric mean ratio (GMR) of the AUC0‐∞ for ET‐26 (GMR 90.0%, 90% CI 85.4%‐94.8%), while co‐administration fluconazole increased the AUC0‐∞ by 18.5% (GMR 118.5%, 90% CI 111.4%‐126.2%). ET‐26 slightly increased the AUC0‐∞ by 18.5% for omeprazole (GMR 118.5%, 90% CI 111.4%‐126.1%) and 11.1% for midazolam (GMR 111.1%, 90% CI 104.9%‐117.8%). The 90% CI for key parameters largely fell within no‐effect boundaries, indicating no clinically significant DDIs. Pharmacodynamic assessments showed consistent sedation profiles across sequences, with mild additive effects with midazolam. Safety evaluations identified treatment‐emergent adverse events such as injection site pain and myoclonus, more frequent with fluconazole. No serious adverse events were observed. These findings suggest ET‐26 exhibits a favorable safety and pharmacokinetic profile with no significant DDIs observed in clinical, supporting its potential as a safer alternative to etomidate for general anesthesia. |
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| AbstractList | Methoxyethyl etomidate hydrochloride (ET-26) is a novel intravenous general anesthetic designed to address the clinical limitations of etomidate. This Phase I clinical trial assessed the pharmacokinetics, pharmacodynamics, drug-drug interaction (DDI) potential, and safety of ET-26 in 68 healthy subjects across three sequences, evaluating interactions with rifampin (CYP2C19/3A4 inducer), fluconazole (CYP2C19/3A4 inhibitor), and omeprazole/midazolam. ET-26 pharmacokinetic analyses showed that compared with administration of ET-26 alone, co-administration of rifampin resulted in a 10% decrease in the geometric mean ratio (GMR) of the AUC0-∞ for ET-26 (GMR 90.0%, 90% CI 85.4%-94.8%), while co-administration fluconazole increased the AUC0-∞ by 18.5% (GMR 118.5%, 90% CI 111.4%-126.2%). ET-26 slightly increased the AUC0-∞ by 18.5% for omeprazole (GMR 118.5%, 90% CI 111.4%-126.1%) and 11.1% for midazolam (GMR 111.1%, 90% CI 104.9%-117.8%). The 90% CI for key parameters largely fell within no-effect boundaries, indicating no clinically significant DDIs. Pharmacodynamic assessments showed consistent sedation profiles across sequences, with mild additive effects with midazolam. Safety evaluations identified treatment-emergent adverse events such as injection site pain and myoclonus, more frequent with fluconazole. No serious adverse events were observed. These findings suggest ET-26 exhibits a favorable safety and pharmacokinetic profile with no significant DDIs observed in clinical, supporting its potential as a safer alternative to etomidate for general anesthesia.Methoxyethyl etomidate hydrochloride (ET-26) is a novel intravenous general anesthetic designed to address the clinical limitations of etomidate. This Phase I clinical trial assessed the pharmacokinetics, pharmacodynamics, drug-drug interaction (DDI) potential, and safety of ET-26 in 68 healthy subjects across three sequences, evaluating interactions with rifampin (CYP2C19/3A4 inducer), fluconazole (CYP2C19/3A4 inhibitor), and omeprazole/midazolam. ET-26 pharmacokinetic analyses showed that compared with administration of ET-26 alone, co-administration of rifampin resulted in a 10% decrease in the geometric mean ratio (GMR) of the AUC0-∞ for ET-26 (GMR 90.0%, 90% CI 85.4%-94.8%), while co-administration fluconazole increased the AUC0-∞ by 18.5% (GMR 118.5%, 90% CI 111.4%-126.2%). ET-26 slightly increased the AUC0-∞ by 18.5% for omeprazole (GMR 118.5%, 90% CI 111.4%-126.1%) and 11.1% for midazolam (GMR 111.1%, 90% CI 104.9%-117.8%). The 90% CI for key parameters largely fell within no-effect boundaries, indicating no clinically significant DDIs. Pharmacodynamic assessments showed consistent sedation profiles across sequences, with mild additive effects with midazolam. Safety evaluations identified treatment-emergent adverse events such as injection site pain and myoclonus, more frequent with fluconazole. No serious adverse events were observed. These findings suggest ET-26 exhibits a favorable safety and pharmacokinetic profile with no significant DDIs observed in clinical, supporting its potential as a safer alternative to etomidate for general anesthesia. Methoxyethyl etomidate hydrochloride (ET‐26) is a novel intravenous general anesthetic designed to address the clinical limitations of etomidate. This Phase I clinical trial assessed the pharmacokinetics, pharmacodynamics, drug–drug interaction (DDI) potential, and safety of ET‐26 in 68 healthy subjects across three sequences, evaluating interactions with rifampin (CYP2C19/3A4 inducer), fluconazole (CYP2C19/3A4 inhibitor), and omeprazole/midazolam. ET‐26 pharmacokinetic analyses showed that compared with administration of ET‐26 alone, co‐administration of rifampin resulted in a 10% decrease in the geometric mean ratio (GMR) of the AUC 0‐∞ for ET‐26 (GMR 90.0%, 90% CI 85.4%‐94.8%), while co‐administration fluconazole increased the AUC 0‐∞ by 18.5% (GMR 118.5%, 90% CI 111.4%‐126.2%). ET‐26 slightly increased the AUC 0‐∞ by 18.5% for omeprazole (GMR 118.5%, 90% CI 111.4%‐126.1%) and 11.1% for midazolam (GMR 111.1%, 90% CI 104.9%‐117.8%). The 90% CI for key parameters largely fell within no‐effect boundaries, indicating no clinically significant DDIs. Pharmacodynamic assessments showed consistent sedation profiles across sequences, with mild additive effects with midazolam. Safety evaluations identified treatment‐emergent adverse events such as injection site pain and myoclonus, more frequent with fluconazole. No serious adverse events were observed. These findings suggest ET‐26 exhibits a favorable safety and pharmacokinetic profile with no significant DDIs observed in clinical, supporting its potential as a safer alternative to etomidate for general anesthesia. Methoxyethyl etomidate hydrochloride (ET‐26) is a novel intravenous general anesthetic designed to address the clinical limitations of etomidate. This Phase I clinical trial assessed the pharmacokinetics, pharmacodynamics, drug–drug interaction (DDI) potential, and safety of ET‐26 in 68 healthy subjects across three sequences, evaluating interactions with rifampin (CYP2C19/3A4 inducer), fluconazole (CYP2C19/3A4 inhibitor), and omeprazole/midazolam. ET‐26 pharmacokinetic analyses showed that compared with administration of ET‐26 alone, co‐administration of rifampin resulted in a 10% decrease in the geometric mean ratio (GMR) of the AUC0‐∞ for ET‐26 (GMR 90.0%, 90% CI 85.4%‐94.8%), while co‐administration fluconazole increased the AUC0‐∞ by 18.5% (GMR 118.5%, 90% CI 111.4%‐126.2%). ET‐26 slightly increased the AUC0‐∞ by 18.5% for omeprazole (GMR 118.5%, 90% CI 111.4%‐126.1%) and 11.1% for midazolam (GMR 111.1%, 90% CI 104.9%‐117.8%). The 90% CI for key parameters largely fell within no‐effect boundaries, indicating no clinically significant DDIs. Pharmacodynamic assessments showed consistent sedation profiles across sequences, with mild additive effects with midazolam. Safety evaluations identified treatment‐emergent adverse events such as injection site pain and myoclonus, more frequent with fluconazole. No serious adverse events were observed. These findings suggest ET‐26 exhibits a favorable safety and pharmacokinetic profile with no significant DDIs observed in clinical, supporting its potential as a safer alternative to etomidate for general anesthesia. Methoxyethyl etomidate hydrochloride (ET-26) is a novel intravenous general anesthetic designed to address the clinical limitations of etomidate. This Phase I clinical trial assessed the pharmacokinetics, pharmacodynamics, drug-drug interaction (DDI) potential, and safety of ET-26 in 68 healthy subjects across three sequences, evaluating interactions with rifampin (CYP2C19/3A4 inducer), fluconazole (CYP2C19/3A4 inhibitor), and omeprazole/midazolam. ET-26 pharmacokinetic analyses showed that compared with administration of ET-26 alone, co-administration of rifampin resulted in a 10% decrease in the geometric mean ratio (GMR) of the AUC for ET-26 (GMR 90.0%, 90% CI 85.4%-94.8%), while co-administration fluconazole increased the AUC by 18.5% (GMR 118.5%, 90% CI 111.4%-126.2%). ET-26 slightly increased the AUC by 18.5% for omeprazole (GMR 118.5%, 90% CI 111.4%-126.1%) and 11.1% for midazolam (GMR 111.1%, 90% CI 104.9%-117.8%). The 90% CI for key parameters largely fell within no-effect boundaries, indicating no clinically significant DDIs. Pharmacodynamic assessments showed consistent sedation profiles across sequences, with mild additive effects with midazolam. Safety evaluations identified treatment-emergent adverse events such as injection site pain and myoclonus, more frequent with fluconazole. No serious adverse events were observed. These findings suggest ET-26 exhibits a favorable safety and pharmacokinetic profile with no significant DDIs observed in clinical, supporting its potential as a safer alternative to etomidate for general anesthesia. |
| Author | Yang, Xiao‐Ran Zhao, Wei Lv, Wen‐Shuo Yang, Xin‐Mei Ke, Bo‐Wen Ye, Pan‐Pan Yang, Fan Zheng, Yi van denAnker, John Li, Li‐Ze Zhao, Bao‐Zhong Song, Lin‐Lin |
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| Keywords | pharmacokinetics Phase 1 clinical trial drug–drug interaction intravenous anesthetic etomidate analogs |
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| Notes | Xiao‐Ran Yang, Yi Zheng, Bo‐Wen Ke, and Wei Zhao contributed equally to this study. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 |
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| SubjectTerms | Adult Adverse events Anesthesia Anesthetics, Intravenous - administration & dosage Anesthetics, Intravenous - adverse effects Anesthetics, Intravenous - pharmacokinetics Anesthetics, Intravenous - pharmacology Area Under Curve Clinical trials Cross-Over Studies Cytochrome P-450 CYP2C19 - metabolism Drug interaction Drug Interactions drug–drug interaction Etomidate Etomidate - administration & dosage Etomidate - adverse effects Etomidate - analogs & derivatives Etomidate - pharmacokinetics Etomidate - pharmacology etomidate analogs Female Fluconazole Fluconazole - administration & dosage Fluconazole - pharmacokinetics Fluconazole - pharmacology Healthy Volunteers Humans intravenous anesthetic Male Midazolam Midazolam - pharmacokinetics Midazolam - pharmacology Middle Aged Myoclonus Omeprazole Omeprazole - pharmacokinetics Omeprazole - pharmacology Pharmacodynamics Pharmacokinetics Phase 1 clinical trial Rifampin Rifampin - pharmacokinetics Rifampin - pharmacology Young Adult |
| Title | Methoxyethyl Etomidate Hydrochloride (ET‐26): A Phase I Clinical Trial Assessing Drug–Drug Interactions in Healthy Subjects |
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