Substance Balance Trial of Methoxyethyl Etomidate Hydrochloride
China6 participantsStarted 2023-07-17
Plain-language 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. 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.
Who can participate
Age range
18 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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 ;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
pharmacokinetic parameters
Timeframe: Up to 168 hours after drug administration.
. 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 ;
. those who are not suitable for arterial blood sampling, such as Allen's test positive;
. 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;
. 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;