Clinical Trial of the Effect of Methoxyethyl Etomidate Hydrochloride on the QT Interval of the Heart

Ahon Pharma

Status and phase

Completed

Phase 1

Conditions

QT Interval, Variation in

Treatments

Drug: ET-26 2.8mg/kg(high dose) group

Drug: ET-26 0.8mg/kg(low-dose) group

Study type

Interventional

Funder types

Other

Identifiers

NCT06822153

ET-26-HCL-CP-002

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Auxiliary examination:

those with clinically significant abnormalities in comprehensive physical examination, vital signs, and laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, serum cortisol);
potentially difficult airway (modified Mallampati score III-IV);
abnormal and clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia as judged by the investigator;
clinically significant abnormal 12-lead ECG, QTcF≥450 ms, PR interval ≥200 ms, QRS complex duration ≥120ms;
hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;

Medication history:
use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening (see Appendix 1 for details);
Use of any known QT-prolonging medication within 30 days before screening (see Appendix 1 for details);
use of any prescribed medication within 14 days before dose;
use of over-the-counter medications, Chinese herbal medicines, or food supplements such as vitamins and calcium supplements within 7 days before administration;

History of disease and surgery:
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;
with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;
a history of severe cardiovascular disease, including but not limited to organic heart disease, such as heart failure, myocardial infarction, angina pectoris, or malignant arrhythmia, as judged by the investigator; 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);
underwent any surgery within 6 months before screening;
allergic constitution, such as known allergic history to two or more substances; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;

Living habits:
heavy drinking or regular drinking in the 6 months before screening, i.e. 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 during the screening period;
used nicotine-containing products between 3 months before screening and study enrollment;
with drug abuse or drug abuse history within 3 months before screening; Or the urine drug test was positive in the screening period;
habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages and inability to quit during the trial;

Others:
who had difficulty in blood collection or could not tolerate blood collection by venipuncture;
participated in any other clinical trial (including drug and device clinical trials) within 3 months before screening;
vaccinated within 1 month before screening or planned to be vaccinated during the trial period;
pregnant or lactating women;
during the trial and within half a year after the completion of the trial, or those who do not agree that the subjects and their spouses should take strict contraceptive measures during the trial and within half a year after the completion of the trial (see Appendix 4 for details);
had blood loss or donation > 400 mL within 3 months before screening, or received blood transfusion within 1 month;
had any factors considered by the investigator to preclude participation in the trial.