Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
Study NCT ID:
NCT06822166
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2025-01-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D015725', 'term': 'Fluconazole'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2025-02-11', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': 'Cmax'}], 'secondaryOutcomes': [{'measure': "modified observer's assessment of alert（MOAA/S） score", 'timeFrame': 'up to 10 minutes after drug administration.', 'description': 'The lowest score was 0, indicating full anesthetic sedation, and the highest score was 5, indicating full consciousness.'}, {'measure': 'bispectral index', 'timeFrame': 'up to 10 minutes after drug administration.', 'description': 'BIS values range from 0 to 100, with higher values indicating more wakefulness and lower values indicating more severe cortical inhibition.'}, {'measure': 'Eyelash reflex', 'timeFrame': 'up to 2 minutes after drug administration.', 'description': "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"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interaction Drug Food']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. healthy adult male and female subjects aged 18-45 years (inclusive);\n2. 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;\n3. 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.\n\nExclusion Criteria:\n\n\\-\n\nAuxiliary examination:\n\n1. if the results of physical examination, vital signs, 12-lead electrocardiogram, cortisol test, and laboratory tests are abnormal and clinically meaningful;\n2. potentially difficult airway;\n3. hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;\n\n Medication history:\n4. use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening;\n5. use of any prescribed medication within 14 days before dosing;\n6. use of over-the-counter drugs, Chinese herbal medicines or food supplements such as vitamins and calcium supplements within 7 days before administration;\n\n History of disease and surgery:\n7. any history of clinically severe illness or any disease or condition that the investigator believes may affect the trial results;\n8. patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;\n9. 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;\n10. underwent any surgery within 6 months before screening;\n11. allergic constitution; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;\n\n Living habits:\n12. 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;\n13. smoked more than 5 cigarettes per day in the 3 months before screening or could not quit smoking during the study;\n14. had a history of drug abuse or drug abuse within 3 months before screening; Or the baseline urine drug test was positive;\n15. habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeinated beverages and inability to quit during the trial;\n\n Others:\n16. those who have difficulty in blood collection, can not tolerate venipuncture or arterial blood collection;\n17. participated in any other clinical trial within 3 months before screening;\n18. vaccinated within 1 month before screening or planned to be vaccinated during the trial period;\n19. pregnant or lactating women;\n20. 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;\n21. had blood loss or donation \\>400 mL within 3 months before screening, or received blood transfusion within 1 month;\n22. subjects with any factors considered by the investigator to be ineligible for the trial.'}, 'identificationModule': {'nctId': 'NCT06822166', 'briefTitle': 'Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride', 'organization': {'class': 'OTHER', 'fullName': 'Ahon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Single-center, Open-label, Single-sequence, Self-crossover Controlled Phase I Clinical Study Evaluating Methoxyethyl Etomidate Hydrochloride Drug Interactions in Healthy Subjects', 'orgStudyIdInfo': {'id': 'ET-26-HCL-CP-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'rifampicin +ET-26', 'interventionNames': ['Drug: rifampicin', 'Drug: ET-26']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'description': 'Fluconazole+ET-26', 'interventionNames': ['Drug: Fluconazole', 'Drug: ET-26']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence C', 'description': 'Omeprazole enteric-coated capsules+midazolam+ET-26', 'interventionNames': ['Drug: Omeprazole', 'Drug: midazolam', 'Drug: ET-26']}], 'interventions': [{'name': 'rifampicin', 'type': 'DRUG', 'description': 'rifampicin capsule，600 mg', 'armGroupLabels': ['Sequence A']}, {'name': 'Fluconazole', 'type': 'DRUG', 'description': 'Fluconazole capsules: 400 mg for the first dose and 200 mg for the remaining doses', 'armGroupLabels': ['Sequence B']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': 'Omeprazole enteric-coated capsules: 20 mg', 'armGroupLabels': ['Sequence C']}, {'name': 'midazolam', 'type': 'DRUG', 'description': 'midazolam injection 0.05 mg/kg was administered intravenously', 'armGroupLabels': ['Sequence C']}, {'name': 'ET-26', 'type': 'DRUG', 'description': 'the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds', 'armGroupLabels': ['Sequence A', 'Sequence B', 'Sequence C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Wei Zhao, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahon Pharmaceutical Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}