Mass Balance Study of [14C] LPM3770164 in Healthy Participants (NCT07516899) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Mass Balance Study of [14C] LPM3770164 in Healthy Participants
China8 participantsStarted 2026-04-30
Plain-language summary
This is a phase 1, single-center, single-dose, open-label mass-balance study to evaluate radioactive recovery rate, radioactive PK characteristics, metabolite identification, and to observe the safety in healthy male subjects of \[14C\] LPM3770164.
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion criteria
✓. Healthy adult Chinese males;
✓. Age at informed consent: 18-45 years (including boundary value);
✓. Body mass index (BMI) range of 19-26 kg/m2 (including the boundary value), and body weight of not less than 50 kg;
✓. There is no plan to have children or donate sperm within 1 year after the participant signs the informed consent form and the participant voluntarily takes strict contraceptive measures within 1 year after signing the informed consent form and completing the trial;
✓. Fully understand the purpose and requirements of this study, and voluntarily sign the informed consent form;
✓. Able to communicate well with the investigators and be able to complete the trial according to the protocol.
Exclusion criteria
✕. Abnormal and clinically significant vital signs, physical examination, chest X-ray (anteroposterior), ophthalmic examination, anal digital examination and abdominal B ultrasound examination;
✕. Abnormal laboratory examination during the screening period, and clinically significant according to the investigator's judgment:
✕. QTcF interval \> 450 ms in men; or other abnormalities are clinically significant in the judgment of the investigator;
✕. Abnormal tests of hepatitis B surface antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), treponema pallidum antibody and human immunodeficiency virus antibody are clinically significant at the investigator's discretion;
What they're measuring
1
Recovery of total radioactivity in excreta (urine and feces) per collection period;
Timeframe: within up to 40 days after dosing
2
Cumulative recovery of total radioactivity in excreta (urine and feces)
Timeframe: within up to 40 days after dosing
3
Percentage of parent drug and its metabolites in plasma to total radioactivity exposure (% AUC) in human plasma
Timeframe: within up to 40 days after dosing
4
Percentage of parent drug and its metabolites in urine and feces to administered dose (% administered dose)
Timeframe: within up to 40 days after dosing
5
Identification of major metabolites in human plasma, urine and feces
Timeframe: within up to 40 days after dosing
6
Peak concentration (Cmax) of total radioactivity in human plasma
Timeframe: within up to 40 days after dosing
7
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf) of total radioactivity in human plasma.
✕. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicine, food supplements within 4 weeks prior to screening;
✕. Use of any drugs that inhibit or induce hepatic drug metabolizing enzyme activity within 4 weeks prior to screening;
✕. History of any clinically significant disease or disease or condition that may affect the results of the trial;
✕. History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, tachycardia, atrioventricular block, QT prolongation syndrome or a family history of QT prolongation syndrome symptoms;