Study on Human Mass Balance of SPH3127 Tablets (NCT05593562) | Clinical Trial Compass
CompletedPhase 1/2
Study on Human Mass Balance of SPH3127 Tablets
China6 participantsStarted 2022-10-16
Plain-language summary
To quantitatively analyze the total radioactivity in the excreta of healthy male subjects after oral administration of \[14C\] SPH3127, and determine the cumulative excretion rate and main excretion routes of radioactive substances; to investigate the partition in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of \[14C\]SPH3127 in healthy male subjects; to identify the main metabolites in healthy male subjects after an oral administration of \[14C\] SPH3127, determine the main biotransformation pathways and main metabolites, quantitatively analyze the concentration of SPH3127 and main metabolites in plasma by validated LC-MS/MS method, and establish the pharmacokinetic parameters of SPH3127 and its main metabolites in plasma.
Who can participate
Age range18 Years ā 45 Years
SexMALE
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Inclusion criteria
ā. Healthy adult male;
ā. Age: 18-45 years (inclusive);
ā. Body weight: the body weight of the subject is ā„ 50 kg, and the body mass index (BMI) is between 19 and 26 kg/m2 (inclusive);
ā. Subject who fully understands the objective, requirements, content, process and possible adverse reactions of this trial, volunteers for the trial, is able to complete the trial according to the trial requirements and comply with study instructions, and the process of obtaining informed consent conforms to GCP;
ā. Subject who can communicate well with the investigator and complete the trial according to the protocol.
Exclusion criteria
ā. Those with clinically significant abnormalities in physical examination, vital signs, laboratory tests, thyroid function, 12-lead ECG, chest CT, abdominal ultrasound and other examinations;
ā. Those positive for combined detection of hepatitis B surface antigen or e antigen, hepatitis C virus antibody IgG, human immunodeficiency virus antigen/antibody and Treponema pallidum antibody;
What they're measuring
1
Cumulative excretion rate of total radioactive substances in excreta
Timeframe: 240 hours
2
The concentration of SPH3127 in plasma
Timeframe: Sampling performed at predose, and 10 minute,20 minute,0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24,48,72,96,120,144and 168 hours post-dose.
3
The total radioactivity in the collected plasma samples
. Screening for SARS-COV-2 infection: those with clinically significant abnormalities in C-reactive protein or positive for SARS-COV-2 RNA;
ā. Those who have used any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days prior to screening;
ā. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements within 14 days prior to screening;
ā. Those who have a history of any clinical serious disease or any disease or condition that the investigator thinks may affect the trial results, including but not limited to the medical history of circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic disorders;
ā. Those with a personal history or family history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmias, torsades de pointes, ventricular tachycardia, atrioventricular block, prolonged QT syndrome;
ā. Those who have undergone major surgery or have incomplete healing of surgical incision within 6 months prior to screening; major surgery includes, but is not limited to, any surgery with significant bleeding risk, prolonged general anesthesia, or open biopsy or significant traumatic injury;