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A Phase I clinical study to compare the pharmacokinetics, pharmacokinetics, and safety of intravenous administration of methoxyetomidate hydrochloride for injection in subjects with mild hepatic insufficiency (Child-pugh A), moderate hepatic insufficiency (Child-Pugh B), and normal hepatic function.Main OBJECTIVE: To evaluate the pharmacokinetic characteristics of metoetomidate hydrochloride for injection in subjects with mild liver dysfunction (Child-Pugh A), moderate liver dysfunction (Child-Pugh B) and normal liver function, and to provide evidence for the clinical application of metoetomidate hydrochloride in patients with liver dysfunction.Secondary objective: To evaluate the safety and pharmacokinetics of metoetomidate hydrochloride for injection in subjects with mild hepatic insufficiency (Child-Pugh A), moderate hepatic insufficiency (Child-Pugh B), and normal hepatic dysfunction.Exploratory objective: To investigate and analyze the relationship between the pharmacokinetic index (MOAA/S, BIS) and the pharmacokinetic parameters of metoetomidate hydrochloride in subjects with different liver function states in this study.The CYP2C19 genotype of the subjects in the study was analyzed, and the influence of gene polymorphism on pharmacokinetic parameters of metoetomidate hydrochloride was explored according to the data of CYP2C19 genotype.The relationship between in vivo exposure to methoxyetomidate hydrochloride and liver injury was analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participants with mild hepatic impairment (Child-Pugh A) | Experimental |
| |
| participants with moderate hepatic impairment (Child-Pugh B) | Experimental |
| |
| Normal hepatic function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ET-26 | Drug | The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | Cmax | up to 5 minutes after infusion |
| Pharmacokinetic parameters | AUC0-inf | immediately after infusion to infinite time |
| Pharmacokinetic parameters | AUC0-t | immediately after infusion to 24 hours after infusion |
| Pharmacokinetic parameters | t1/2 | up to 6 hours after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic indicators | MOAA/S score | once within 10 minutes before dosing, once 1 minutes (±5seconds) after dosing, and once 2minutes (±30 seconds) after stopping dosing and during full wakefulness |
| Pharmacodynamic indicators |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanhua Ding, MD | Contact | 18186879768 | 130021 | dingyanhua2003@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, MD | The First Hospital of Jilin University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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BIS score
| 10 minutes before administration to full wakefulness, once every 1 minute |