Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride

NCT06822166 | Completed Phase 1

• 1 other identifier: ET-26-HCL-CP-006
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic Parameter(ET-26/ etomidate acid)

  Cmax

  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 (3)

• modified observer's assessment of alert（MOAA/S） score

  up to 10 minutes after drug administration.

• bispectral index

  up to 10 minutes after drug administration.

• Eyelash reflex

  up to 2 minutes after drug administration.

Study Arms (3)

Sequence A

EXPERIMENTAL

rifampicin +ET-26

Drug: rifampicin; Drug: ET-26

Sequence B

EXPERIMENTAL

Fluconazole+ET-26

Drug: Fluconazole; Drug: ET-26

Sequence C

EXPERIMENTAL

Omeprazole enteric-coated capsules+midazolam+ET-26

Drug: Omeprazole; Drug: midazolam; Drug: ET-26

Interventions

rifampicin DRUG

rifampicin capsule，600 mg

Sequence A

Fluconazole DRUG

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

Sequence B

Omeprazole DRUG

Omeprazole enteric-coated capsules: 20 mg

Sequence C

midazolam DRUG

midazolam injection 0.05 mg/kg was administered intravenously

Sequence C

ET-26 DRUG

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

Sequence A; Sequence B; Sequence C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adult male and female subjects aged 18-45 years (inclusive);
• 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;
• 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.

You may not qualify if:

• Auxiliary examination:
• if the results of physical examination, vital signs, 12-lead electrocardiogram, cortisol test, and laboratory tests are abnormal and clinically meaningful;
• potentially difficult airway;
• hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
• Medication history:
• use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening;
• use of any prescribed medication within 14 days before dosing;
• 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:
• any history of clinically severe illness or any disease or condition that the investigator believes may affect the trial results;
• patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;
• 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;
• underwent any surgery within 6 months before screening;
• allergic constitution; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;
• Living habits:

Sponsors & Collaborators

• Ahon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

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

Jinan, Shandong, 250014, China

Location

MeSH Terms

Interventions

Rifampin; Fluconazole; Omeprazole; Midazolam

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Benzodiazepines; Benzazepines

Study Officials

• Wei Zhao, Doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 12, 2025
• Study Start: December 4, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

CN (1)