Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride

NCT ID: NCT06822166

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2024-01-23

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.

Conditions

Interaction Drug Food

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sequence A

rifampicin +ET-26

Group Type: EXPERIMENTAL

rifampicin

Intervention Type: DRUG

rifampicin capsule，600 mg

ET-26

Intervention Type: DRUG

the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds

Sequence B

Fluconazole+ET-26

Group Type: EXPERIMENTAL

Fluconazole

Intervention Type: DRUG

Fluconazole capsules: 400 mg for the first dose and 200 mg for the remaining doses

ET-26

Intervention Type: DRUG

the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds

Sequence C

Omeprazole enteric-coated capsules+midazolam+ET-26

Group Type: EXPERIMENTAL

Omeprazole

Intervention Type: DRUG

Omeprazole enteric-coated capsules: 20 mg

midazolam

Intervention Type: DRUG

midazolam injection 0.05 mg/kg was administered intravenously

ET-26

Intervention Type: DRUG

the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds

Interventions

rifampicin

rifampicin capsule，600 mg

Intervention Type: DRUG

Fluconazole

Fluconazole capsules: 400 mg for the first dose and 200 mg for the remaining doses

Intervention Type: DRUG

Omeprazole

Omeprazole enteric-coated capsules: 20 mg

Intervention Type: DRUG

midazolam

midazolam injection 0.05 mg/kg was administered intravenously

Intervention Type: DRUG

ET-26

the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ahon Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Zhao, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)

Locations

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)

Jinan, Shandong, China

Countries

China

Other Identifiers

ET-26-HCL-CP-006

Identifier Type: -

Identifier Source: org_study_id