Interaction Drug FoodPhase 1NCT06822166
Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride
A Phase 1 study testing rifampicin, Fluconazole and Omeprazole in people with Interaction Drug Food, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Interaction Drug Food
- What is being tested?
- rifampicin, Fluconazole and Omeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2023to 23 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- -
- 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:
Show all 28Show fewer
- 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:
- 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;
- smoked more than 5 cigarettes per day in the 3 months before screening or could not quit smoking during the study;
- had a history of drug abuse or drug abuse within 3 months before screening; Or the baseline urine drug test was positive;
- habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeinated beverages and inability to quit during the trial;
- Others:
- those who have difficulty in blood collection, can not tolerate venipuncture or arterial blood collection;
- participated in any other clinical trial within 3 months before screening;
- vaccinated within 1 month before screening or planned to be vaccinated during the trial period;
- pregnant or lactating women;
- 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;
- had blood loss or donation >400 mL within 3 months before screening, or received blood transfusion within 1 month;
- subjects with any factors considered by the investigator to be ineligible for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Jinan, Shandong, 250014
About this study
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
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
- Being tested
- rifampicin, Fluconazole, Omeprazole, midazolam, ET-26
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rifampicinDrug
rifampicin capsule，600 mg
FluconazoleDrug
Fluconazole capsules: 400 mg for the first dose and 200 mg for the remaining doses
OmeprazoleDrug
Omeprazole enteric-coated capsules: 20 mg
midazolamDrug
midazolam injection 0.05 mg/kg was administered intravenously
ET-26Drug
the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | rifampicin +ET-26 Receives: Drug: rifampicin; Drug: ET-26 |
| Sequence B | Experimental | Fluconazole+ET-26 Receives: Drug: Fluconazole; Drug: ET-26 |
| Sequence C | Experimental | Omeprazole enteric-coated capsules+midazolam+ET-26 Receives: Drug: Omeprazole; Drug: midazolam; Drug: ET-26 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameter(ET-26/ etomidate acid)
Cmax
Measured: 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
The lowest score was 0, indicating full anesthetic sedation, and the highest score was 5, indicating full consciousness.
Measured: up to 10 minutes after drug administration.
bispectral index
BIS values range from 0 to 100, with higher values indicating more wakefulness and lower values indicating more severe cortical inhibition.
Measured: up to 10 minutes after drug administration.
Eyelash reflex
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
Measured: up to 2 minutes after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start4 Dec 2023
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interaction Drug FoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Zhao, Doctor, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822166
- Sponsor's protocol ID
- ET-26-HCL-CP-006
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06822166
- Acronym / sponsor ID
- ET-26-HCL-CP-006
- Conditions
- Interaction Drug Food
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: rifampicin, Drug: ET-26rifampicin +ET-26 |
| Sequence B | Experimental | Drug: Fluconazole, Drug: ET-26Fluconazole+ET-26 |
| Sequence C | Experimental | Drug: Omeprazole, Drug: midazolam, Drug: ET-26Omeprazole enteric-coated capsules+midazolam+ET-26 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (28 listed)
- -
- 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;
- use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rifampicinrifampicin capsule，600 mg | Drug | Sequence A |
| FluconazoleFluconazole capsules: 400 mg for the first dose and 200 mg for the remaining doses | Drug | Sequence B |
| OmeprazoleOmeprazole enteric-coated capsules: 20 mg | Drug | Sequence C |
| midazolammidazolam injection 0.05 mg/kg was administered intravenously | Drug | Sequence C |
| ET-26the dose is 0.8 mg/kg, single dose, Infusion time was 60seconds ± 5seconds | Drug | Sequence A, Sequence B, Sequence C |
Primary outcome
Pharmacokinetic Parameter(ET-26/ etomidate acid)
Time frame: 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
3 secondary outcomes
modified observer's assessment of alert（MOAA/S） score
Time frame: up to 10 minutes after drug administration.
bispectral index
Time frame: up to 10 minutes after drug administration.
Eyelash reflex
Time frame: up to 2 minutes after drug administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhao, Doctor principal investigator
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rifampicin, Fluconazole and Omeprazole in people with Interaction Drug Food, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameter(ET-26/ etomidate acid) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.