Clinical trial NCT06822166: Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride
Official title: A Single-center, Open-label, Single-sequence, Self-crossover Controlled Phase I Clinical Study Evaluating Methoxyethyl Etomidate Hydrochloride Drug Interactions in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Interaction Drug Food
Lead sponsor: Ahon Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Sixty-eight healthy subjects were divided into three sequences: A, B and C. The effects of CYP2C19 inhibitor fluconazole and inducer rifampicin on ET-26-HCl injection were evaluated, and the effects of ET-26-HCl injection on pharmacokinetics of omeprazole and midazolam were evaluated.


Eligibility criteria: Inclusion Criteria:

1. healthy adult male and female subjects aged 18-45 years (inclusive);
2. Body weight: body mass index (BMI) between 18.0 and 30.0 kg/m2 (including the cut-off value), with a body weight of at least 50 kg for male subjects and 45 kg for female subjects;
3. The subjects had good communication with the investigators, signed the informed consent form voluntarily, and were able to complete the trial according to the protocol.

Exclusion Criteria:

-

Auxiliary examination:

1. if the results of physical examination, vital signs, 12-lead electrocardiogram, cortisol test, and laboratory tests are abnormal and clinically meaningful;
2. potentially difficult airway;
3. hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;

   Medication history:
4. use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening;
5. use of any prescribed medication within 14 days before dosing;
6. use of over-the-counter drugs, Chinese herbal medicines or food supplements such as vitamins and calcium supplements within 7 days before administration;

   History of disease and surgery:
7. any history of clinically severe illness or any disease or condition that the investigator believes may affect the trial results;
8. patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;
9. a history of severe cardiovascular disease, including but not limited to a history of organic heart disease, such as heart failure, myocardial infarction, angina, malignant arrhythmia, such as a history of torssion ventricular tachycardia, ventricular tachycardia, long QT syndrome, or symptoms of long QT syndrome and family history;
10. underwent any surgery within 6 months before screening;
11. allergic constitution; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;

    Living habits:
12. heavy drinking or regular drinking in the 6 months before screening, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or with a positive alcohol breath test at baseline;
13. smoked more than 5 cigarettes per day in the 3 months before screening or could not quit smoking during the study;
14. had a history of drug abuse or drug abuse within 3 months before screening; Or the baseline urine drug test was positive;
15. habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeinated beverages and inability to quit during the trial;

    Others:
16. those who have difficulty in blood collection, can not tolerate venipuncture or arterial blood collection;
17. participated in any other clinical trial within 3 months before screening;
18. vaccinated within 1 month before screening or planned to be vaccinated during the trial period;
19. pregnant or lactating women;
20. childbearing or sperm donation plan during the trial and half a year after the completion of the trial, or do not agree that the subjects and their spouses should take strict contraceptive measures during the trial and half a year after the completion of the trial;
21. had blood loss or donation \>400 mL within 3 months before screening, or received blood transfusion within 1 month;
22. subjects with any factors considered by the investigator to be ineligible for the trial.

Primary outcomes:
measure: Pharmacokinetic Parameter(ET-26/ etomidate acid)
timeFrame: within 1 hour before and 24 hours after the end of ET-26-HCl.from 1 hour before administration of omeprazole enteric-coated capsules until 24 hours after the end of administration.
Secondary outcomes:
measure: modified observer's assessment of alert（MOAA/S） score
timeFrame: up to 10 minutes after drug administration.
measure: bispectral index
timeFrame: up to 10 minutes after drug administration.
measure: Eyelash reflex
timeFrame: up to 2 minutes after drug administration.
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
state: Shandong
Study officials:
affiliation: The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
name: Wei Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: