PharmacokineticsPhase 1NCT06822114
Substance Balance Trial of Methoxyethyl Etomidate Hydrochloride
A Phase 1 study testing Methoxyethyl Etomidate Hydrochloride in people with Pharmacokinetics, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study was a single-center, single-dose, open-label design with 6-8 healthy adult male subjects to evaluate the body material balance of [14C]ET-26. Each subject received a single intravenous injection of [14C]ET-26 at a dose of 50 µCi/48 mg. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Methoxyethyl Etomidate Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2023to 31 Jul 2023
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy Chinese men;
- The age of signing the informed consent: 18-45 years old;
- Body mass index of 19-26 kg/m2, body weight of 60 kg±5kg;
- fully understand the purpose and requirements of the study, and voluntarily sign the informed consent;
- Able to communicate well with investigators and complete the trial according to the protocol.
Who cannot join
- -
- Auxiliary examination:
- Those with clinically significant abnormalities in comprehensive physical examination, vital signs, laboratory tests, serum cortisol, 12-lead electrocardiogram, chest X-ray, digital anal examination, abdominal ultrasound ;
- potentially difficult airway ;
- resting corrected QT interval (QTcF) > 450 ms obtained by 12-lead electrocardiogram;
- hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG , or treponema pallidum antibody testing, human immunodeficiency virus antigen/antibody combination testing ;
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- those who are not suitable for arterial blood sampling, such as Allen's test positive;
- Medication history:
- patients who had taken any prescription drugs, over-the-counter drugs, Chinese herbal medicine, or food supplements from 14 days before screening to the time of drug administration;
- Use of any drugs that inhibit or induce liver drug enzymes or affect the body's cortisol level between 30 days before screening and before drug administration;
- History of disease and surgery:
- patients with a history of any clinically serious disease or disease or condition considered by the investigators to be likely to affect the results of the trial, including but not limited to a history of cardiovascular, respiratory, endocrine, nervous, digestive, urinary, or hematologic, immune, psychiatric, or metabolic diseases;
- patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;
- patients with anesthetic accident history, malignant high fever history or related family history;
- previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, long QT syndrome or symptoms of long QT syndrome and family history ;
- had a history or current respiratory disease, including respiratory insufficiency, obstructive lung disease, asthma, or bronchospasm requiring treatment within 3 months before screening; Or acute respiratory infection within one week before screening, with obvious symptoms such as fever, wheezing, nasal congestion and cough;
- patients who underwent major surgery within 6 months prior to screening or who had incompletely healed surgical incisions, including but not limited to any surgery with a significant risk of bleeding, prolonged general anesthesia, or open biopsy or significant traumatic injury;
- allergic constitution, such as known allergic history to two or more substances; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;
- patients with hemorrhoids or perianal diseases with regular/ongoing hematochezia, gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease;
- Living habits:
- habitual constipation or diarrhea;
- were heavy drinkers or regular drinkers in the 6 months before screening, i.e., drank more than 14 units of alcohol per week (1 unit =360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine), had an alcohol breath test ≥20 mg/dl at screening, or were unable to abstain from alcohol during the trial;
- smoked more than 5 cigarettes per day or were habitual users of nicotine-containing products in the 3 months before screening, or were unable to quit during the trial;
- abusing drugs or using soft drugs 3 months before screening or hard drugs 1 year before screening; Or positive urine drug test during screening period;
- habitual drinkers of grapefruit juice or excessive tea, coffee and/or caffeinated beverages who were unable to abstain during the trial;
- with strenuous exercise and other factors affecting drug absorption, distribution, metabolism and excretion;
- Others:
- workers who are exposed to radioactive conditions for a long time, or have had significant radiation exposure within 1 year before screening, or participated in radiopharyngology labeling tests;
- patients with a history of syncope, or difficulty in blood collection, or can not tolerate venipuncture blood collection;
- those who had taken any investigational drug or used any investigational device within 3 months before screening;
- vaccinated within 1 month before screening or planned to be vaccinated during the trial period;
- had plans to give birth or donate sperm within 1 year after signing the informed consent form, or did not agree to take strict contraceptive measures for the subjects and their spouses within 1 year after completing the study ;
- if they had lost blood or donated ≥400 mL within 3 months before screening, received a transfusion or blood component within 1 month, or were planning to donate blood during the trial;
- those who have special requirements for diet or cannot abide by the uniform diet; Or they refused to discontinue any beverage containing xanthine derivatives such as caffeine for 48 hours before drug administration until the end of the study; The subjects refused to stop eating animal offal, seafood, soy products and other foods with high purine content.
- had any other factors considered by the investigator to preclude participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: Substance Balance of [14C]ET-26 in Healthy Chinese Subjects
This study was a single-center, single-dose, open-label design with 6-8 healthy adult male subjects to evaluate the body material balance of [14C]ET-26. Each subject received a single intravenous injection of [14C]ET-26 at a dose of 50 µCi/48 mg. Blood, urine, and stool samples were collected at specified times during the study. The pharmacokinetic parameters were calculated, and the distribution of total radioactivity in venous whole blood and plasma was analyzed. The excretion rate and pathway were analyzed. The metabolic pathway and elimination pathway of ET-26 in human body were analyzed.
- Conditions
- Pharmacokinetics
- Being tested
- Methoxyethyl Etomidate Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxyethyl Etomidate HydrochlorideDrug
The dose is 50 μCi/48 mg，in the fasting state, a single intravenous injection was given slowly
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Methoxyethyl Etomidate Hydrochloride Receives: Drug: Methoxyethyl Etomidate Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetic parameters
Cmax
Measured: Up to 168 hours after drug administration.
Secondary outcomes (1)
MOAA/S score
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 20 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 start17 Jul 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, Doctor, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822114
- Sponsor's protocol ID
- ET-26-HCL-CP-001
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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
- Substance Balance of [14C]ET-26 in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT06822114
- Acronym / sponsor ID
- ET-26-HCL-CP-001
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (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.
This study was a single-center, single-dose, open-label design with 6-8 healthy adult male subjects to evaluate the body material balance of [14C]ET-26. Each subject received a single intravenous injection of [14C]ET-26 at a dose of 50 µCi/48 mg. Blood, urine, and stool samples were collected at specified times during the study. The pharmacokinetic parameters were calculated, and the distribution of total radioactivity in venous whole blood and plasma was analyzed. The excretion rate and pathway were analyzed. The metabolic pathway and elimination pathway of ET-26 in human body were analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Methoxyethyl Etomidate HydrochlorideMethoxyethyl Etomidate Hydrochloride |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy Chinese men;
- The age of signing the informed consent: 18-45 years old;
- Body mass index of 19-26 kg/m2, body weight of 60 kg±5kg;
- fully understand the purpose and requirements of the study, and voluntarily sign the informed consent;
- Able to communicate well with investigators and complete the trial according to the protocol.
Key exclusion criteria (35 listed)
- -
- Those with clinically significant abnormalities in comprehensive physical examination, vital signs, laboratory tests, serum cortisol, 12-lead electrocardiogram, chest X-ray, digital anal examination, abdominal ultrasound ;
- potentially difficult airway ;
- resting corrected QT interval (QTcF) > 450 ms obtained by 12-lead electrocardiogram;
- hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG , or treponema pallidum antibody testing, human immunodeficiency virus antigen/antibody combination testing ;
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 |
|---|---|---|
| Methoxyethyl Etomidate HydrochlorideThe dose is 50 μCi/48 mg，in the fasting state, a single intravenous injection was given slowly | Drug | experimental group |
Primary outcome
pharmacokinetic parameters
Time frame: Up to 168 hours after drug administration.
Cmax
1 secondary outcome
MOAA/S score
Time frame: Up to 20 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.
Liyan Miao, Doctor principal investigator
The First Affiliated Hospital of Soochow University
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 Methoxyethyl Etomidate Hydrochloride in people with Pharmacokinetics, 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 5 inclusion and 35 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 parameters (time frame: Up to 168 hours after drug 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.