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 range
18 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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;
. 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;