Clinical Trial of the Effect of Methoxyethyl Etomidate Hydrochloride on the QT Interval of the Heart (NCT06822153) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial of the Effect of Methoxyethyl Etomidate Hydrochloride on the QT Interval of the Heart
China18 participantsStarted 2023-11-09
Plain-language summary
A single intravenous injection of 0.8mg/kg or 2.8mg/kg Et-26-hcl was given to 18 subjects. The effect of plasma concentration on QT interval was evaluated by C-QTc effect model, and the pharmacokinetic characteristics and safety of ET-26 and etomidate acid were evaluated.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Healthy adult male and female subjects;
✓. Age: 18-45 years old;
✓. Body weight: body mass index (BMI) between 19.0 and 28.0 kg/m2, with a body weight of at least 50 kg for male subjects and 45 kg for female subjects;
✓. voluntarily sign informed consent;
✓. Subjects were able to communicate well with investigators and complete the trial in accordance with the protocol.
Exclusion criteria
✕. those with clinically significant abnormalities in comprehensive physical examination, vital signs, and laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, serum cortisol);
✕. abnormal and clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia as judged by the investigator;