Phase 1 Renal Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride

NCT06747520 | Completed Phase 1

• 1 other identifier: ET-26-HCL-CP-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Twenty-four subjects were divided into three groups: subjects with mild renal insufficiency, subjects with moderate renal insufficiency and subjects with normal renal function, with 8 subjects in each group.Subjects with mild renal insufficiency and moderate renal insufficiency were enrolled first, and then subjects with normal renal function were matched according to age, weight and gender. All patients received a single intravenous injection of 0.8mg/kg ET-26. To compare the pharmacokinetic characteristics of ET-26 and etomidate acid in subjects with mild and moderate renal insufficiency and normal renal function, and to provide clinical guidance for the use of ET-26 in patients with mild and moderate renal insufficiency.

Conditions

Renal Insufficiency

Keywords

Clinical Pharmacology; renal insufficiency

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic parameters

  Cmax

  up to 24 hours after infusion

• Pharmacokinetic parameters

  AUC0-t

  immediately after infusion to 24 hours after infusion

• Pharmacokinetic parameters

  t1/2

  up to 6 hours after infusion

Secondary Outcomes (2)

• Pharmacodynamic indicators

  MOAA/S score was measured three times within 60 minutes before administration as baseline value, was performed every 1 minute±5seconds for 5minutes after administration and every 2minutes±30seconds for 5minutes after administration

• Pharmacodynamic indicators

  BIS score was measured three times within 60 minutes before administration as baseline value,was performed every 1 minute±5seconds within 5minutes after administration, and every 2minutes±30seconds after 5minutes, until MOAA/S score ≥5

Study Arms (3)

mild renal insufficiency（group A）

EXPERIMENTAL

0.8mg/kg group

Drug: ET-26HCl

moderate renal insufficiency（group B）

EXPERIMENTAL

0.8mg/kg group

Drug: ET-26HCl

normal renal function（group C）

EXPERIMENTAL

0.8mg/kg group

Drug: ET-26HCl

Interventions

ET-26HCl DRUG

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

mild renal insufficiency（group A）; moderate renal insufficiency（group B）; normal renal function（group C）

Eligibility Criteria

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

You may qualify if:

• \- All subjects
• adult male and female subjects aged ≥18 years;
• Body weight: body mass index (BMI) between 18.0 and 30.0 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;
• The subjects had good communication with the investigators, voluntarily signed the informed consent form and were able to complete the trial in accordance with the protocol; Subjects with renal insufficiency
• The glomerular filtration rate (GFR) should meet the following criteria: mild renal insufficiency 60-89 mL/min (including both ends), moderate renal insufficiency subjects 30-59 mL/min (including both ends);
• stable renal function with two absolute eGFR results (separated by at least 3 days) within the same CKD stage before administration;
• no medication within 14 days before screening or with a stable medication regimen for renal impairment or other comorbidities (no adjustment in medication type, dose, or frequency for at least 2 weeks);
• In addition to renal insufficiency and complications, the investigator judged the recipient's physical status according to medical history inquiry, physical examination, vital signs, cortisol test, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), and 12-lead electrocardiogram.
• Subjects with normal renal function 8) matched with the renal insufficiency group by age (±10 years), weight (±15 kg), and gender (1:1); 9) GFR ≥90 mL/min; 10) normal or abnormal results of physical examination, vital signs, cortisol test, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), and 12-lead electrocardiogram without clinical significance.

You may not qualify if:

• \- All subjects
• potentially difficult airway (modified Mallampati score III-IV);
• hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
• use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 14 days before screening;
• a history of severe cardiovascular disease, including but not limited to organic heart disease, such as heart failure, myocardial infarction, angina pectoris, and malignant arrhythmia; 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);
• patients with severe infection, trauma, major surgery, or digestive system surgery within 1 month before screening that affect drug absorption;
• those with allergic constitution, such as those with a known history of allergic to two or more substances; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;
• binge drinking or regular drinking in the 6 months before screening, defined as 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 at baseline;
• smokers with an average of more than 5 cigarettes per day in the 3 months before screening or unable to quit smoking during the study;
• those with drug abuse or drug use history within 3 months before screening; Or the baseline urine drug test was positive;
• habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages and inability to quit during the trial;
• those who have difficulty in blood collection or cannot tolerate blood collection by venipuncture;
• participated in any other clinical trials (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;

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

Conditions

Renal Insufficiency

Interventions

ET-26 compound

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Wei Zhao, Pharmaciae Doctor

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

  STUDY DIRECTOR

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 18, 2024
• First Posted: December 24, 2024
• Study Start: November 30, 2023
• Primary Completion: February 21, 2024
• Study Completion: February 28, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

CN (1)