Substance Balance Trial of Methoxyethyl Etomidate Hydrochloride
China6 participantsStarted 2023-07-17
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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 ;
What they're measuring
1
pharmacokinetic parameters
Timeframe: Up to 168 hours after drug administration.
✕. those who are not suitable for arterial blood sampling, such as Allen's test positive;
✕. 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;
✕. 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;