Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride

Phase 1

Completed

• Conditions: Interaction Drug Food
• Interventions: Drug: rifampicin; Drug: Fluconazole; Drug: Omeprazole; Drug: midazolam; Drug: ET-26

• Registration Number: NCT06822166
• Lead Sponsor: Ahon Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-04
• Primary Completion: 2024-01-23
• Study Completion: 2024-01-23
• Study First Submitted: 2025-01-24
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-11
• Study First Posted: 2025-02-12
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	rifampicin	rifampicin +ET-26
Sequence B	Fluconazole	Fluconazole+ET-26
Sequence C	Omeprazole	Omeprazole enteric-coated capsules+midazolam+ET-26
Sequence C	midazolam	Omeprazole enteric-coated capsules+midazolam+ET-26
Sequence A	ET-26	rifampicin +ET-26
Sequence C	ET-26	Omeprazole enteric-coated capsules+midazolam+ET-26
Sequence B	ET-26	Fluconazole+ET-26

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameter(ET-26/ etomidate acid)	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.	Cmax

Secondary Outcome Measures

Name	Time	Method
modified observer's assessment of alert（MOAA/S） score	up to 10 minutes after drug administration.	The lowest score was 0, indicating full anesthetic sedation, and the highest score was 5, indicating full consciousness.
bispectral index	up to 10 minutes after drug administration.	BIS values range from 0 to 100, with higher values indicating more wakefulness and lower values indicating more severe cortical inhibition.
Eyelash reflex	up to 2 minutes after drug administration.	Gently touching the subject's eyelashes with a cotton swab can cause the subject to blink, that is, there is an eyelash reflex. When the eyelash reflex disappears, the patient has entered a state of anesthesia

Trial Locations

Locations (1)

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province); 🇨🇳 Jinan, Shandong, China