Phase 1 Renal Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride
China24 participantsStarted 2023-11-30
Plain-language summary
Twenty-four subjects were divided into three groups: subjects with mild renal insufficiency, subjects with moderate renal insufficiency and subjects with normal renal function, with 8 subjects in each group.Subjects with mild renal insufficiency and moderate renal insufficiency were enrolled first, and then subjects with normal renal function were matched according to age, weight and gender. All patients received a single intravenous injection of 0.8mg/kg ET-26. To compare the pharmacokinetic characteristics of ET-26 and etomidate acid in subjects with mild and moderate renal insufficiency and normal renal function, and to provide clinical guidance for the use of ET-26 in patients with mild and moderate renal insufficiency.
Who can participate
Age range
18 Years
Sex
ALL
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
. adult male and female subjects aged ≥18 years;
. 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, voluntarily signed the informed consent form and were able to complete the trial in accordance with the protocol; Subjects with renal insufficiency
. The glomerular filtration rate (GFR) should meet the following criteria: mild renal insufficiency 60-89 mL/min (including both ends), moderate renal insufficiency subjects 30-59 mL/min (including both ends);
. stable renal function with two absolute eGFR results (separated by at least 3 days) within the same CKD stage before administration;
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 24 hours after infusion
2
Pharmacokinetic parameters
Timeframe: immediately after infusion to 24 hours after infusion
. no medication within 14 days before screening or with a stable medication regimen for renal impairment or other comorbidities (no adjustment in medication type, dose, or frequency for at least 2 weeks);
. In addition to renal insufficiency and complications, the investigator judged the recipient's physical status according to medical history inquiry, physical examination, vital signs, cortisol test, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), and 12-lead electrocardiogram.
. 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 14 days before screening;
. a history of severe cardiovascular disease, including but not limited to organic heart disease, such as heart failure, myocardial infarction, angina pectoris, and malignant arrhythmia; Such as a history of torssion ventricular tachycardia, ventricular tachycardia, long QT syndrome or symptoms of long QT syndrome and family history (as indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes);
. patients with severe infection, trauma, major surgery, or digestive system surgery within 1 month before screening that affect drug absorption;
. those with allergic constitution, such as those with a known history of allergic to two or more substances; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;
. binge drinking or regular drinking in the 6 months before screening, defined as 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;
. smokers with an average of more than 5 cigarettes per day in the 3 months before screening or unable to quit smoking during the study;