NCT06822114

Brief Summary

This study was a single-center, single-dose, open-label design with 6-8 healthy adult male subjects to evaluate the body material balance of \[14C\]ET-26. Each subject received a single intravenous injection of \[14C\]ET-26 at a dose of 50 µCi/48 mg. Blood, urine, and stool samples were collected at specified times during the study. The pharmacokinetic parameters were calculated, and the distribution of total radioactivity in venous whole blood and plasma was analyzed. The excretion rate and pathway were analyzed. The metabolic pathway and elimination pathway of ET-26 in human body were analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

14 days

First QC Date

January 25, 2025

Last Update Submit

February 12, 2025

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetic parameters

    Cmax

    Up to 168 hours after drug administration.

Secondary Outcomes (1)

  • MOAA/S score

    Up to 20 minutes after drug administration.

Study Arms (1)

experimental group

EXPERIMENTAL

Methoxyethyl Etomidate Hydrochloride

Drug: Methoxyethyl Etomidate Hydrochloride

Interventions

Methoxyethyl Etomidate HydrochlorideDRUG

The dose is 50 μCi/48 mg，in the fasting state, a single intravenous injection was given slowly

experimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy Chinese men;
  • The age of signing the informed consent: 18-45 years old;
  • Body mass index of 19-26 kg/m2, body weight of 60 kg±5kg;
  • fully understand the purpose and requirements of the study, and voluntarily sign the informed consent;
  • Able to communicate well with investigators and complete the trial according to the protocol.

You may not qualify if:

  • Auxiliary examination:
  • Those with clinically significant abnormalities in comprehensive physical examination, vital signs, laboratory tests, serum cortisol, 12-lead electrocardiogram, chest X-ray, digital anal examination, abdominal ultrasound ;
  • potentially difficult airway ;
  • resting corrected QT interval (QTcF) \> 450 ms obtained by 12-lead electrocardiogram;
  • hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG , or treponema pallidum antibody testing, human immunodeficiency virus antigen/antibody combination testing ;
  • those who are not suitable for arterial blood sampling, such as Allen's test positive;
  • Medication history:
  • patients who had taken any prescription drugs, over-the-counter drugs, Chinese herbal medicine, or food supplements from 14 days before screening to the time of drug administration;
  • Use of any drugs that inhibit or induce liver drug enzymes or affect the body's cortisol level between 30 days before screening and before drug administration;
  • History of disease and surgery:
  • patients with a history of any clinically serious disease or disease or condition considered by the investigators to be likely to affect the results of the trial, including but not limited to a history of cardiovascular, 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 with anesthetic accident history, malignant high fever history or related family history;
  • previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, long QT syndrome or symptoms of long QT syndrome and family history ;
  • had a history or current respiratory disease, including respiratory insufficiency, obstructive lung disease, asthma, or bronchospasm requiring treatment within 3 months before screening; Or acute respiratory infection within one week before screening, with obvious symptoms such as fever, wheezing, nasal congestion and cough;
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Study Officials

  • Liyan Miao, Doctor

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2025

First Posted

February 12, 2025

Study Start

July 17, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

February 14, 2025

Record last verified: 2025-02

Locations

CN(1)