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

NCT07516899 | Not Yet Recruiting Phase 1

• 1 other identifier: LY03015/CT-CHN-105
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Huntington Disease

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Treatment-emergent adverse event

  From baseline to 40 days after doing

Study Arms (1)

[14C] LPM3770164

EXPERIMENTAL

20 mg/150 µCi \[14C\] LPM3770164

Drug: [14C] LPM3770164

Interventions

[14C] LPM3770164 DRUG

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

[14C] LPM3770164

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• 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;
• 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;
• Habitual diarrhea or average bowel movement frequency less than once daily;
• 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;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Location

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

yiqing Zhao, Doctor

CONTACT

+8613358100007; 13358100007@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (1)