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NCT07516899Not yet recruitingPhase 1

Mass Balance Study of [14C] LPM3770164 in Healthy Participants

Source: ClinicalTrials.gov · Last updated 8 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
8 (estimated)
First submitted
1 Apr 2026
Start date
30 Apr 2026
Primary completion date
30 Jun 2026
Lead sponsor
Luye Pharma Group Ltd.
NCT number
NCT07516899

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 8
  • From 30 Apr 2026 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • . Patients with dysphagia, esophageal stenosis or gastrointestinal diseases that cause clinically significant symptoms or with a history of severe vomiting and diarrhea in the week prior screening;
  • Patients who previously underwent surgery that would affect the absorption, distribution, metabolism and excretion of drugs, or had undergone major surgery or had incomplete healing of surgical incision within 6 months prior to the screening period; or planned to undergo surgery during the study period;
  • History of drug, food, or environmental allergy, especially to components similar to the investigational product, or a known allergic constitution;
  • Alcoholics or regular drinkers within 6 months before screening, that is, drinking more than 14 units of alcohol per week, or alcohol breath test results \> 0 mg/100ml at screening, or drinkers within 48 hours before the use of the test drug, or unable to abstain from alcohol during the test;
  • The average daily smoking amount in the 3 months before screening is greater than 5 cigarettes or habitual use of nicotine-containing products, or unable to abstain during the trial;
  • Previous history of drug abuse or drug abuse, or positive urine drug abuse screening;
  • Excessive consumption of tea, coffee and/or caffeine-rich beverages, grapefruit juice and other beverages that affect liver enzyme activity per day within 3 months before screening, or inability to abstain during the trial;
  • Those who have participated in any clinical trial within 3 months prior to screening and have received investigational drugs or used investigational devices; or those who plan to participate in other clinical trials during this study;
  • Those who have received vaccination within 4 weeks prior to screening or plan to receive vaccination during the trial to 1 month after the end of the trial.

Other illness

  • 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;
  • History of any clinically significant disease or disease or condition that may affect the results of the trial;
  • Patients with symptomatic hemorrhoids or diseases accompanied by regular/ongoing hematochezia, irritable bowel syndrome, and inflammatory bowel disease;
  • History of congenital or acquired urinary tract stenosis, prostatic hyperplasia, or abnormal bladder function;
  • Workers engaged in long-term exposure to radioactive conditions, or those with significant radioactive exposure;
  • Those with a history of fainting, blood, or difficult to collect blood or unable to tolerate venipuncture blood collection;

Lab values

  • Abnormal laboratory examination during the screening period, and clinically significant according to the investigator's judgment:
  • 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;

Other

  • Abnormal and clinically significant vital signs, physical examination, chest X-ray (anteroposterior), ophthalmic examination, anal digital examination and abdominal B ultrasound examination;
  • QTcF interval \> 450 ms in men; or other abnormalities are clinically significant in the judgment of the investigator;
  • Habitual diarrhea or average bowel movement frequency less than once daily;
  • Those with special requirements for diet or failing to comply with the unified diet;
  • Those who plan to have strenuous exercise during the trial;
  • Blood loss or blood donation;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 45 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Affiliated Hospital of Jiangnan University
Coordinator of this site? Confirm its status
WuxiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.