Huntington DiseasePhase 1NCT07516899
Mass Balance Study of [14C] LPM3770164 in Healthy Participants
A Phase 1 study testing [14C] LPM3770164 in people with Huntington Disease, run by Luye Pharma Group Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- [14C] LPM3770164
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 30 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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 with special requirements for diet or failing to comply with the unified diet;
- Those who plan to have strenuous exercise during the trial;
- Workers engaged in long-term exposure to radioactive conditions, or those with significant radioactive exposure;
- Blood loss or blood donation;
- Those with a history of fainting, blood, or difficult to collect blood or unable to tolerate venipuncture blood collection;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu
yiqing Zhao, Doctor, +8613358100007, 13358100007@126.com
About this study
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
- Being tested
- [14C] LPM3770164
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] LPM3770164Drug
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
| Study group | Role | What they receive |
|---|---|---|
| [14C] LPM3770164 | Experimental | 20 mg/150 µCi [14C] LPM3770164 Receives: Drug: [14C] LPM3770164 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of total radioactivity in excreta (urine and feces) per collection period;
Measured: within up to 40 days after dosing
Cumulative recovery of total radioactivity in excreta (urine and feces)
Measured: within up to 40 days after dosing
Percentage of parent drug and its metabolites in plasma to total radioactivity exposure (% AUC) in human plasma
Measured: within up to 40 days after dosing
Percentage of parent drug and its metabolites in urine and feces to administered dose (% administered dose)
Measured: within up to 40 days after dosing
Identification of major metabolites in human plasma, urine and feces
Measured: within up to 40 days after dosing
Peak concentration (Cmax) of total radioactivity in human plasma
Measured: 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.
Measured: within up to 40 days after dosing
Secondary outcomes (1)
Treatment-emergent adverse event
Measured: From baseline to 40 days after doing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516899
- Sponsor's protocol ID
- LY03015/CT-CHN-105
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Balance Study of [14C] LPM3770164 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07516899
- Acronym / sponsor ID
- LY03015/CT-CHN-105
- Conditions
- Huntington Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C] LPM3770164 | Experimental | Drug: [14C] LPM377016420 mg/150 µCi [14C] LPM3770164 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C] LPM3770164The 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 | Drug | [14C] LPM3770164 |
Primary outcome
Recovery of total radioactivity in excreta (urine and feces) per collection period;
Time frame: within up to 40 days after dosing
Cumulative recovery of total radioactivity in excreta (urine and feces)
Time frame: within up to 40 days after dosing
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
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
Identification of major metabolites in human plasma, urine and feces
Time frame: within up to 40 days after dosing
Peak concentration (Cmax) of total radioactivity in human plasma
Time frame: 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.
Time frame: within up to 40 days after dosing
1 secondary outcome
Treatment-emergent adverse event
Time frame: From baseline to 40 days after doing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C] LPM3770164 in people with Huntington Disease, run by Luye Pharma Group Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yiqing Zhao, Doctor (+8613358100007, 13358100007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of total radioactivity in excreta (urine and feces) per collection period; (time frame: within up to 40 days after dosing). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.