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 range18 Years
SexALL
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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;
. 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;