ClinicalTrials.gg
Not yet recruitingNCT07516899Updated Apr 8, 2026

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

A Phase 1 interventional study of [14C] LPM3770164 in Huntington Disease, sponsored by Luye Pharma Group Ltd.. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Luye Pharma Group Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Huntington Disease

Browse trials for

03

In context

Huntington Disease

293 studies on the registry are indexed under Huntington Disease; 54 are open to participants now.

This study's planned enrollment of 8 is below the median of 40 across 207 interventional studies indexed under Huntington Disease.

Browse Huntington Disease studies →

Lead sponsor

Luye Pharma Group Ltd. is the lead sponsor of 74 studies on the registry; 15 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy adult Chinese males;
  2. Age at : 18-45 years (including boundary value);
  3. (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 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

Exclusion Criteria:

  1. Abnormal and 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. interval > 450 ms in men; or other abnormalities are clinically significant in the judgment of the investigator;
  4. Abnormal tests of surface antigen, virus antibody IgG (Anti-HCV IgG), treponema pallidum antibody and 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 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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Experimental
    [14C] LPM3770164

    20 mg/150 µCi \[14C\] LPM3770164

    Drug: [14C] LPM3770164

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. Recovery of total radioactivity in excreta (urine and feces) per collection period;

    Time frame: within up to 40 days after dosing

  2. Cumulative recovery of total radioactivity in excreta (urine and feces)

    Time frame: 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

    Time frame: within up to 40 days after dosing

  4. Percentage of parent drug and its metabolites in urine and feces to administered dose (% administered dose)

    Time frame: within up to 40 days after dosing

  5. Identification of major metabolites in human plasma, urine and feces

    Time frame: within up to 40 days after dosing

  6. Peak concentration (Cmax) of total radioactivity in human plasma

    Time frame: 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.

    Time frame: within up to 40 days after dosing

Secondary outcomes

  1. Treatment-emergent adverse event

    Time frame: From baseline to 40 days after doing

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07516899
Responsible party
Sponsor
First posted
Apr 8, 2026
Start date
Apr 30, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Jul 30, 2026 (estimated)
Last update
Apr 8, 2026

Study contacts

yiqing Zhao, Doctor
Contact
13358100007@126.com
+8613358100007

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: LPM3770164

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