Status:
UNKNOWN
Phase 1 Hepatic Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride
Lead Sponsor:
Ahon Pharmaceutical Co., Ltd.
Conditions:
Hepatic Insufficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 insuf...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06176716
Start Date
December 6 2023
End Date
April 30 2024
Last Update
December 20 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
First Hospital of Jilin University
Changchun, Jilin, China, 130021