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

NCT06822153 | Completed Phase 1

• 1 other identifier: ET-26-HCL-CP-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

QT Interval, Variation in

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters

  Cmax

  from 1 hour before administration of et-26 until 24 hours after the end of administration.

Secondary Outcomes (2)

• MOAA/S

  up to 10 minutes after drug administration

• Eyelash reflex

  up to 2 minutes after drug administration

Study Arms (2)

low-dose group

OTHER

Placebo+ET-26 0.8mg/kg

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

High dose group

OTHER

Placebo+ET-26 2.8mg/kg

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

Interventions

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

In a 2:1 ratio, Placebo was administered with normal saline and ET-26 0.8mg/kg for a duration of 60 ±5 seconds.

low-dose group

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

In a 2:1 ratio, Placebo was administered with normal saline and ET-26 2.8mg/kg for a duration of 60 ±5 seconds.

High dose group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Ahon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Qing Wen, Master

  Jinan Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 12, 2025
• Study Start: November 9, 2023
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

CN (1)