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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Huntington Disease
• Intervention / Treatment: Drug: [14C] LPM3770164

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: yiqing Zhao, Doctor; Phone Number: +8613358100007; Email: 13358100007@126.com

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China
      • Affiliated Hospital of Jiangnan University
      • Contact: yiqing Zhao, Doctor; Phone Number: +8613358100007; Email: 13358100007@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult Chinese males;
2. Age at informed consent: 18-45 years (including boundary value);
3. Body mass index (BMI) range of 19-26 kg/m2 (including the boundary value), and body weight of not less than 50 kg;
4. 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;
5. Fully understand the purpose and requirements of this study, and voluntarily sign the informed consent form;
6. Able to communicate well with the investigators and be able to complete the trial according to the protocol.

Exclusion Criteria:

1. Abnormal and clinically significant vital signs, physical examination, chest X-ray (anteroposterior), ophthalmic examination, anal digital examination and abdominal B ultrasound examination;
2. Abnormal laboratory examination during the screening period, and clinically significant according to the investigator's judgment:
3. QTcF interval > 450 ms in men; or other abnormalities are clinically significant in the judgment of the investigator;
4. 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;
5. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicine, food supplements within 4 weeks prior to screening;
6. Use of any drugs that inhibit or induce hepatic drug metabolizing enzyme activity within 4 weeks prior to screening;
7. History of any clinically significant disease or disease or condition that may affect the results of the trial;
8. 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;
9. . 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;
10. 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;
11. History of drug, food, or environmental allergy, especially to components similar to the investigational product, or a known allergic constitution;
12. Patients with symptomatic hemorrhoids or diseases accompanied by regular/ongoing hematochezia, irritable bowel syndrome, and inflammatory bowel disease;
13. History of congenital or acquired urinary tract stenosis, prostatic hyperplasia, or abnormal bladder function;
14. Habitual diarrhea or average bowel movement frequency less than once daily;
15. 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;
16. 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;
17. Previous history of drug abuse or drug abuse, or positive urine drug abuse screening;
18. 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;
19. Those with special requirements for diet or failing to comply with the unified diet;
20. Those who plan to have strenuous exercise during the trial;
21. Workers engaged in long-term exposure to radioactive conditions, or those with significant radioactive exposure;
22. Blood loss or blood donation;
23. Those with a history of fainting, blood, or difficult to collect blood or unable to tolerate venipuncture blood collection;
24. 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;
25. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C] LPM3770164; 20 mg/150 µCi [14C] LPM3770164	Drug: [14C] LPM3770164; The subjects are required to take 20 mg/150 µCi [14C] LPM3770164 tablet (s) in the fasted state with a total of approximately 240 mL of water to ensure completion within 5 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recovery of total radioactivity in excreta (urine and feces) per collection period;	within up to 40 days after dosing
Cumulative recovery of total radioactivity in excreta (urine and feces)	within up to 40 days after dosing
Percentage of parent drug and its metabolites in plasma to total radioactivity exposure (% AUC) in human plasma	within up to 40 days after dosing
Percentage of parent drug and its metabolites in urine and feces to administered dose (% administered dose)	within up to 40 days after dosing
Identification of major metabolites in human plasma, urine and feces	within up to 40 days after dosing
Peak concentration (Cmax) of total radioactivity in human plasma	within up to 40 days after dosing
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf) of total radioactivity in human plasma.	within up to 40 days after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment-emergent adverse event	From baseline to 40 days after doing

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Neurocognitive Disorders; Cognition Disorders; Dementia; Neurodegenerative Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Basal Ganglia Diseases; Dyskinesias; Chorea; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Huntington Disease
• Other Study ID Numbers: LY03015/CT-CHN-105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No