Safety and Pharmacokinetics/ Pharmacodynamics of Methoxyethyl Etomidate Hydrochloride in Healthy … (NCT06764147) | Clinical Trial Compass
CompletedPhase 1
Safety and Pharmacokinetics/ Pharmacodynamics of Methoxyethyl Etomidate Hydrochloride in Healthy Elderly Subjects
China16 participantsStarted 2023-12-25
Plain-language summary
16 subjects were divided into two groups: One group consisted of healthy non-elderly subjects aged 18-64 years (including boundary value). The other group was healthy elderly subjects, aged ≥65 years old, of which no less than 3 cases were ≥75 years old, with 8 subjects in each group.Healthy non-elderly subjects will be included as matched control subjects. The gender of healthy non-elderly subjects was consistent with that of healthy elderly subjects. The mean body weight of the healthy non-elderly subjects was within the range of the mean body weight of the healthy elderly subjects ±10 kg.
All patients received a single intravenous injection of 0.8mg/kg ET-26. To evaluate the pharmacokinetic characteristics of ET-26 and provide guidance for the clinical application of ET-26-hcl.
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
. healthy adult male and female subjects aged ≥18 years;
. Body weight: body mass index (BMI) between 19.0 and 28.0 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;
. Blood pressure of healthy subjects should be between 90-139/60-89 mmHg, heart rate and pulse should be between 55-100 beats/min
. 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.
Exclusion criteria
. If the results of physical examination, vital signs, color Doppler echocardiography (only for healthy elderly subjects), cortisol test, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine) and 12-lead electrocardiogram were abnormal and clinically significant by investigator evaluation;
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: up to 6 hours after infusion
3
Pharmacokinetic parameters
Timeframe: up to 12 hours after infusion
4
Pharmacokinetic parameters
Timeframe: immediately after infusion to 24 hours after infusion
. 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;
. 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;
. have a history of any clinically serious diseases or diseases or conditions considered by the investigators to be likely to affect the results of the trial, including but not limited to a history of circulatory, 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;