Hepatic InsufficiencyPhase 1NCT06176716
Phase 1 Hepatic Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride
A Phase 1 study testing ET-26 in people with Hepatic Insufficiency, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- ET-26
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2023to 30 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions
- 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
Who cannot join
- Average daily smoking in the 3 months prior to screening was greater than 5 cigarettes
- Patients with contraindications to deep sedation/general anesthesia or with a history of sedation/anesthesia accidents
- Subjects with a history of epilepsy
- Known to be allergic to methetomidate hydrochloride excipients for injection (mannitol, anhydrous disodium hydrogen phosphate);Or allergy (including drug allergy, allergic disease history, etc.)
- 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)
- History of drug abuse in the 3 months prior to the screening period, or use of benzodiazepines for more than 3 months
Show all 23Show fewer
- Donate blood or plasma within 30 days prior to screening, or blood loss ≥200 mL, or plasmapheresis
- 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
- 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)
- 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]
- Female subjects were lactating or had a positive blood pregnancy during the screening period or during the trial
- 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
- 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
- People who were expected to have a tendency to surgery or hospitalization during the trial period
- 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
- Urine drug screening positive (morphine, methamphetamine, ketamine, cannabis, ecstasy)
- People who have used propofol, other sedative/narcotic drugs and/or opioid analgesics or combinations containing analgesics within 72 hours prior to administration
- Those who had any other factors deemed unsuitable by the investigator for participation in the study
- 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
- 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)
- 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
- Patients with liver dysfunction: a history of liver transplantation
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130021
liyuan Zhao, MD, 0431-88782013, kjkzhaoliyuan@126.com
About this study
Official title: 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.
- Conditions
- Hepatic Insufficiency
- Being tested
- ET-26
- Keywords
- Clinical Pharmacology, Hepatic insufficiency
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET-26Drug
The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.
| Study group | Role | What they receive |
|---|---|---|
| participants with mild hepatic impairment (Child-Pugh A) | Experimental | Not described Receives: Drug: ET-26 |
| participants with moderate hepatic impairment (Child-Pugh B) | Experimental | Not described Receives: Drug: ET-26 |
| Normal hepatic function | Experimental | Not described Receives: Drug: ET-26 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Cmax
Measured: up to 5 minutes after infusion
Pharmacokinetic parameters
AUC0-inf
Measured: immediately after infusion to infinite time
Pharmacokinetic parameters
AUC0-t
Measured: immediately after infusion to 24 hours after infusion
Pharmacokinetic parameters
t1/2
Measured: up to 6 hours after infusion
Secondary outcomes (2)
Pharmacodynamic indicators
MOAA/S score
Measured: 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
BIS score
Measured: 10 minutes before administration to full wakefulness, once every 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start6 Dec 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, MD, Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176716
- Sponsor's protocol ID
- ET-26-HCl-CP-003
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu Y, Zheng W, Zhang H, Li L, Diao L, Yang X, Ding Y. Pharmacokinetics, safety, and pharmacodynamics of intravenous methoxyethyl etomidate hydrochloride (ET-26-HCl) in Chinese participants with hepatic impairment. Front Pharmacol. 2026 Jul 30;17:1827752. doi: 10.3389/fphar.2026.1827752. eCollection 2026.
PubMed 42597983
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06176716
- Acronym / sponsor ID
- ET-26-HCl-CP-003
- Conditions
- Hepatic Insufficiency
- Keywords
- Clinical Pharmacology, Hepatic insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| participants with mild hepatic impairment (Child-Pugh A) | Experimental | Drug: ET-26 |
| participants with moderate hepatic impairment (Child-Pugh B) | Experimental | Drug: ET-26 |
| Normal hepatic function | Experimental | Drug: ET-26 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions
- 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
Key exclusion criteria (23 listed)
- Average daily smoking in the 3 months prior to screening was greater than 5 cigarettes
- Patients with contraindications to deep sedation/general anesthesia or with a history of sedation/anesthesia accidents
- Subjects with a history of epilepsy
- Known to be allergic to methetomidate hydrochloride excipients for injection (mannitol, anhydrous disodium hydrogen phosphate);Or allergy (including drug allergy, allergic disease history, etc.)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ET-26The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s. | Drug | Normal hepatic function, participants with mild hepatic impairment (Child-Pugh A), participants with moderate hepatic impairment (Child-Pugh B) |
Primary outcome
Pharmacokinetic parameters
Time frame: up to 5 minutes after infusion
Cmax
Pharmacokinetic parameters
Time frame: immediately after infusion to infinite time
AUC0-inf
Pharmacokinetic parameters
Time frame: immediately after infusion to 24 hours after infusion
AUC0-t
Pharmacokinetic parameters
Time frame: up to 6 hours after infusion
t1/2
2 secondary outcomes
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
Pharmacodynamic indicators
Time frame: 10 minutes before administration to full wakefulness, once every 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 42597983Hu Y, Zheng W, Zhang H, Li L, Diao L, Yang X, Ding Y. Pharmacokinetics, safety, and pharmacodynamics of intravenous methoxyethyl etomidate hydrochloride (ET-26-HCl) in Chinese participants with hepatic impairment. Front Pharmacol. 2026 Jul 30;17:1827752. doi: 10.3389/fphar.2026.1827752. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanhua Ding, MD study director
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ET-26 in people with Hepatic Insufficiency, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanhua Ding, MD (18186879768 ext. 130021, dingyanhua2003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters (time frame: up to 5 minutes after infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06176716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.