Safety and Pharmacokinetics/ Pharmacodynamics of Methoxyethyl Etomidate Hydrochloride in Healthy Elderly Subjects

NCT06764147 | Completed Phase 1

• 1 other identifier: ET-26-HCL-CP-005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Elderly Subjects

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic parameters

  Cmax

  up to 24 hours after infusion

• Pharmacokinetic parameters

  Tmax

  up to 6 hours after infusion

• Pharmacokinetic parameters

  T1/2

  up to 12 hours after infusion

• Pharmacokinetic parameters

  AUC0-t

  immediately after infusion to 24 hours after infusion

Secondary Outcomes (3)

• Pharmacodynamic indicators

  MOAA/S score was measured within 60 minutes before administration, was performed every 1 minute±5second within 5minutes of administration and every 2minutes ±30seconds after 5minutes of administration

• Pharmacodynamic indicators

  BIS score was measured within 60 minutes before administration as baseline value,was performed every 1 minute±5second within 5minutes of administration and every 2minutes±30seconds after 5minutes of administration

• Pharmacodynamic indicators：Eyelash reflex

  every 1 minute± 5seconds during the first 5minutes of administration and every 2minutes ±30seconds after 5minutes of administration

Study Arms (2)

Non-elderly group

EXPERIMENTAL

aged 18-64 years (including boundary value)

Drug: ET-26HCl

Elderly group

EXPERIMENTAL

aged ≥65 years old, of which no less than 3 cases were ≥75 years old

Drug: ET-26HCl

Interventions

ET-26HCl DRUG

The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.

Elderly group; Non-elderly group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Auxiliary examination:
• 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;
• potentially difficult airway (modified Mallampati score III-IV);
• 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;
• 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;
• 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;
• patients with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;
• patients who 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:
• binge drinking or regular drinking in the 6 months before screening, i.e. 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 at baseline;

Sponsors & Collaborators

• Ahon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)

Jinan, Shandong, 250014, China

Location

MeSH Terms

Interventions

ET-26 compound

Study Officials

• Wei Zhao, Pharmaciae Doctor

  The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 8, 2025
• Study Start: December 25, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

CN (1)