Phase 1 Hepatic Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride

December 17, 2023 updated by: Ahon Pharmaceutical Co., Ltd.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions
  2. Be able to complete the study according to the requirements of the test plan 3 Subjects (including partners) were willing to voluntarily use effective contraception from screening until 6 months after the last study drug administration 4 Male or female subjects aged 18-70 years (including cut-off) 5 The weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg.Body Mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 18-32 kg/m2 (including the threshold) 6 Blood pressure should be between 90-159/60-99 mmHg (including the cutoff);The heart rate should be between 55-100 beats/min (including the critical value);SpO2 suction air should be ≥95% 7 For subjects with normal liver function, normal or abnormal clinical laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) have no clinical significance 8 No potentially difficult airway (modified Markov score of grade I to II) 9 Subjects with normal liver function had no prior serious primary diseases of major organs, including but not limited to gastrointestinal, respiratory, kidney, liver, nervous, blood, endocrine, tumor, immune, mental, or cardiovascular and cerebrovascular diseases 10 Liver insufficiency with Child-Pugh grade A or B is liver insufficiency due to prior primary liver disease, including but not limited to non-alcoholic steatohepatitis, viral hepatitis (hepatitis B, hepatitis C), etc 11 Patients with liver dysfunction: have not taken medication within 4 weeks prior to screening, or require long-term treatment due to liver disease or other comorbidification and have a stable medication regimen (try to avoid CYP3A4 or CYP2C19 suppressors and strong inducers) 12 Patients with hepatic insufficiency: the glomerular filtration rate eGFR > 60mL/min/1.73m2

Exclusion Criteria:

  1. Average daily smoking in the 3 months prior to screening was greater than 5 cigarettes
  2. Patients with contraindications to deep sedation/general anesthesia or with a history of sedation/anesthesia accidents
  3. Subjects with a history of epilepsy
  4. Known to be allergic to methetomidate hydrochloride excipients for injection (mannitol, anhydrous disodium hydrogen phosphate);Or allergy (including drug allergy, allergic disease history, etc.)
  5. History of alcohol abuse in the 3 months prior to screening (average daily drinking > 2 units of alcohol (1 unit = 285 mL for beer, or 25 mL for spirits, or 100 mL for wine)
  6. History of drug abuse in the 3 months prior to the screening period, or use of benzodiazepines for more than 3 months
  7. Donate blood or plasma within 30 days prior to screening, or blood loss ≥200 mL, or plasmapheresis
  8. Subjects with normal liver function: Use of any prescription drug or Chinese herbal medicine in the 2 weeks prior to screening other than contraceptives, paracetamol, nonsteroidal anti-inflammatory drugs, local over-the-counter topical preparations
  9. Participants who participated in any drug clinical trials within 2 months prior to screening (Participants with liver dysfunction who participated in three or more drug clinical trials within 1 year prior to screening should also be excluded)
  10. ECG abnormalities were clinically significant and were judged by the investigator to be unsuitable for participation in the study [if tachycardia/bradycardia, degree II-III atrioventricular block, or prolonged QTcF interval requiring drug therapy (male ≥470 ms, female ≥480 ms),Corrected by Fridericia's formula) or otherwise clinically significant abnormalities determined by the clinician]
  11. Female subjects were lactating or had a positive blood pregnancy during the screening period or during the trial
  12. Subjects with normal liver function who tested positive for any of the indicators of hepatitis B surface antigen, hepatitis C antibody or hepatitis C core antigen, HIV antigen/antibody or syphilis antibody
  13. Patients with serious or clinically significant infections (such as respiratory or central nervous system infections), trauma, or major surgical operations within 4 weeks prior to screening
  14. People who were expected to have a tendency to surgery or hospitalization during the trial period
  15. People who have consumed any food or beverage containing alcohol (or positive breath test for alcohol), grapefruit/grapefruit juice, methylxanthine (e.g., coffee, tea, cola, chocolate), strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc., in the 1 day prior to administration
  16. Urine drug screening positive (morphine, methamphetamine, ketamine, cannabis, ecstasy)
  17. People who have used propofol, other sedative/narcotic drugs and/or opioid analgesics or combinations containing analgesics within 72 hours prior to administration
  18. Those who had any other factors deemed unsuitable by the investigator for participation in the study
  19. Patients with hepatic insufficiency: In addition to the primary liver disease itself, or any clinically significant clinical laboratory test abnormality and/or serious history that the investigator believes may affect the test results, including but not limited to gastrointestinal, respiratory, renal, neurological, hematological, endocrine, immune, psychiatric, or cardiovascular and cerebrovascular diseases
  20. patients with liver dysfunction: alpha-fetoprotein > 100 ng/mL;Hemoglobin (Hgb) < 80 g/L, platelet ≤50×109/L;Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 times the upper limit of normal (ULN)
  21. Patients with liver insufficiency: patients with liver failure, or patients with hepatic encephalopathy, hepatocellular carcinoma (except Barcelona stage 0), esophageal variceal hemorrhage and other complications of cirrhosis that researchers consider inappropriate
  22. Patients with liver dysfunction: a history of liver transplantation
  23. Patients with liver dysfunction: HIV antigen/antibody screening positive;If syphilis antibody is positive, the rapid plasma rereaction hormone test (RPR) test should be added, and if RPR is also positive, it should be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Normal hepatic function
Drug: ET-26
The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.
Experimental: participants with mild hepatic impairment (Child-Pugh A)
Drug: ET-26
The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.
Experimental: participants with moderate hepatic impairment (Child-Pugh B)
Drug: ET-26
The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters
Time Frame: up to 5 minutes after infusion
Cmax
up to 5 minutes after infusion
Pharmacokinetic parameters
Time Frame: immediately after infusion to infinite time
AUC0-inf
immediately after infusion to infinite time
Pharmacokinetic parameters
Time Frame: immediately after infusion to 24 hours after infusion
AUC0-t
immediately after infusion to 24 hours after infusion
Pharmacokinetic parameters
Time Frame: up to 6 hours after infusion
t1/2
up to 6 hours after infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacodynamic indicators
Time Frame: once within 10 minutes before dosing, once 1 minutes (±5seconds) after dosing, and once 2minutes (±30 seconds) after stopping dosing and during full wakefulness
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
Time Frame: 10 minutes before administration to full wakefulness, once every 1 minute
BIS score
10 minutes before administration to full wakefulness, once every 1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahon Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yanhua Ding, MD, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ET-26-HCl-CP-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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